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Ketorolac

  • Prescription medicine
  • Withdrawn
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Ketorolac does in the body

Ketorolac blocks the same prostaglandin-making enzymes as ibuprofen.

What makes it different is delivery: given into a vein or muscle it reaches a high blood concentration quickly, which produces pain relief comparable to what an opioid dose would give, without touching opioid receptors — so no sedation, no respiratory depression, no dependence. The cost is that every NSAID effect arrives at that same intensity: platelets stop working, the stomach lining loses its protection and the kidney loses its backup blood-flow control, all at once. That is why the licensed course is five days and why the list of people who must not receive it is longer than for any other drug in this group.

Why people take it. Severe short-term pain, usually after surgery or in hospital

What happened in people

Intravenous ketorolac at 10, 15 and 30 mg produced indistinguishable pain reduction at 30 minutes in 240 randomised patients

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That ketorolac is pharmacologically as strong as an opioid — the label describes it as opioid-sparing and as indicated for pain requiring analgesia at the opioid level, which is a statement about the setting rather than the molecule

Where it acts
The cyclooxygenase channel throughout the body, reached rapidly by injection — including in platelets, gastric mucosa and kidney, all three of which appear in the boxed warning
Kind of result
Symptoms and quality of life
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C19H24N2O6, weighing 376.41.

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 141 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
PainWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer11 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
time to a 50 reduction in reported pain intensity; vas pain; pain at rest; pain; pain on movement; pain relief local anti flammatory effects; pain after instilation; numerical rating scale pain scores during hospitalization

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Pain reduction on a numeric rating scale at 30 minutes

The study showed what it set out to show

Who was studied
Three-dose intravenous ketorolac trial (Ann Emerg Med 2017;70:177-184)
How many people
240
Study design
Randomised, double-blind, three-arm dose comparison
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
No differences between 10, 15 and 30 mg intravenously — 95% confidence intervals 4.5 to 5.7, 4.5 to 5.6 and 4.2 to 5.4 respectively; mean scores falling from 7.7, 7.5 and 7.8 at baseline to 5.1, 5.0 and 4.8 at 30 minutes
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The trial demonstrates equal analgesia and did not measure whether platelet inhibition, renal effects or gastric prostaglandin suppression were also equal across the three doses — and the surveillance data show a dose-response for bleeding. Single-centre, ages 18 to 65, with ulcer, renal and hepatic disease excluded.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Gastrointestinal and operative site bleeding with parenteral ketorolac against matched courses of a parenteral opiate

The study did not show it

Who was studied
Parenteral ketorolac postmarketing surveillance cohort (JAMA 1996;275:376-382)
How many people
20519
Study design
Postmarketing surveillance inception cohort study across 35 hospitals, 1991-1993
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Gastrointestinal bleeding adjusted odds ratio 1.30 (95% CI 1.11 to 1.52); operative site bleeding 1.02 (0.95 to 1.10). Beyond five days of therapy, gastrointestinal bleeding 2.20 (1.36 to 3.57) against 1.17 (0.99 to 1.30) at five days or fewer. Age 75 or older: 1.66 (1.23 to 2.25)
Repeated elsewhere
Partially Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Observational, with courses matched by hospital, admitting service and start date rather than randomised. A dose-response relationship was evident for both bleeding endpoints (trend test P<0.001). This is the study behind the five-day boxed limit.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions

Interval reported. 95% CI 1

Written into the record, not signed off as a reviewed claim.

Adjusted relative risk of upper gastrointestinal complications for individual NSAIDs against non-use

The study did not show it

Who was studied
SOS project pooled observational analysis (Drug Saf 2012;35:1127-1146)
How many people
28
Study design
Systematic review and meta-analysis of 28 cohort and case-control studies of upper gastrointestinal complications
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Ketorolac relative risk 11.50 (95% CI 5.56 to 23.78) — second highest of any NSAID examined, behind azapropazone at 18.45
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. The confidence interval is very wide and confounding by indication is acute: ketorolac is given to postoperative and severely injured inpatients whose baseline bleeding risk differs sharply from a community NSAID user’s. The sample-size field records pooled studies, not participants.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions

Interval reported. 95% CI 5

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.11 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Ketorolac

    What a person takes: Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions.

    The measurement behind this step

    Given as the tromethamine salt for water solubility. The maximum daily injection dose is 120 mg against 40 mg for the oral tablets, and the injection ceiling falls to 60 mg total daily in patients 65 or older, under 50 kg, or with moderately elevated serum creatinine. Oral ketorolac is not a stand-alone product: the label states it is indicated only as continuation treatment following intravenous or intramuscular dosing, with a combined five-day maximum across both routes.

  2. Getting in

    An ordinary NSAID delivered in an extraordinary way

    At the enzyme, ketorolac is nothing special — a non-selective blocker like ibuprofen. What makes it different is that it goes into a vein or a muscle and reaches a high concentration within minutes.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    A pyrrolizine carboxylic acid given as the tromethamine salt for solubility. Non-selective PTGS1 and PTGS2 inhibition, activity residing in the S-enantiomer of the marketed racemate. Maximum daily injection dose 120 mg against 40 mg orally — a threefold difference that is the whole basis of the drug’s clinical position.

  3. The change it makes

    Pain relief arrives at opioid-level intensity, without an opioid receptor

    It relieves pain severe enough that an opioid would otherwise be used, and it does so without sedation, without slowing breathing and without dependence.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    The label indicates it for moderately severe acute pain requiring analgesia at the opioid level, usually postoperatively, and records an opioid-sparing effect when used with morphine or meperidine. There is no opioid receptor interaction; the mechanism is prostaglandin suppression at a high plasma concentration.

  4. What it acts on

    And it stops there — the curve is flat above 10 mg

    Tripling the intravenous dose does not triple the relief. In a randomised trial, 10, 15 and 30 mg gave identical pain scores at thirty minutes.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Randomised double-blind trial in 240 emergency department patients: mean numeric rating scale 7.7, 7.5 and 7.8 at baseline falling to 5.1, 5.0 and 4.8 at 30 minutes for 10, 15 and 30 mg, with overlapping confidence intervals, similar rescue analgesia and similar adverse effects. The boxed warning had asserted this ceiling since approval.

  5. Reaching the cell

    Every other cyclooxygenase effect arrives at the same intensity

    Platelets stop clumping, the stomach lining loses its protection and the kidney loses its backup blood-flow control — all at the concentration that produced the pain relief.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Platelet function inhibition is why the label contraindicates use before major surgery and in any bleeding-risk state. Gastric mucosal prostaglandin suppression underlies the absolute contraindication in peptic ulcer disease or prior gastrointestinal bleeding. Renal prostaglandin dependence underlies the contraindication in advanced renal impairment and volume depletion.

  6. What that does for a person

    Which is why the clock starts on day one

    Within five days, the bleeding difference against an opioid is marginal. Past five days it more than doubles. That is where the limit comes from.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Gastrointestinal bleeding odds ratio against parenteral opiates: 1.17 (0.99 to 1.30) at five days or fewer, 2.20 (1.36 to 3.57) beyond five days, across 20,519 matched courses. Age 75 or older raised the overall odds ratio to 1.66 (1.23 to 2.25). Operative site bleeding was unaffected by duration at 1.02 (0.95 to 1.10).

  7. What that does for a person

    What was measured, and what was assumed

    Measured: the dose ceiling, the five-day threshold, the absence of extra surgical bleeding, and the highest gastrointestinal complication risk in this file. Assumed: that it is as powerful as morphine, which its label describes only as opioid-sparing.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Pooled observational upper gastrointestinal complication relative risk 11.50 (5.56 to 23.78), second highest of any NSAID examined. Label: not indicated for paediatric patients, not for minor or chronic painful conditions, contraindicated alongside aspirin or any other NSAID, and contraindicated as a prophylactic analgesic before major surgery.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • time to a 50 reduction in reported pain intensity
  • vas pain
  • pain at rest
  • pain
  • pain on movement
  • pain relief local anti flammatory effects
  • pain after instilation
  • post operative pain
  • pain scale
  • headache pain level on a 0 10 verbal scale

and 1 more.

Measured

Things only a test, a scale or a device shows.

  • maximum observed plasma concentration

Meaningful

Things that change how a life goes, not only a number.

  • numerical rating scale pain scores during hospitalization

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (27)
  • best corrected visual acuity at all study visits
  • degree of corneal haze at all study visits
  • time to epithelial closure in each eye after prk
  • satisfaction
  • interocular pressure
  • ocular comfort
  • acute pseudophakic cystoid macular edema
  • opioid consumption
  • hyperalgesia
  • post operative febrile morbidity
  • morphine consumption
  • intraocular pressure
  • intraocular pressure change
  • peak aqueous penetration
  • aqueous pge2 inhibition
  • visual analog
  • analgesic efficacy
  • cmax
  • tmax
  • auc 0 8h

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 2.5 hours hours

    Read from the label, which states: “The half-life of the ketorolac tromethamine S-enantiomer was approximately 2.5 hours (SD ± 0.4) compared with 5 hours (SD ± 1.7) for the R-enantiomer.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with severe acute pain, usually in hospital or an emergency department. The label states it is not indicated for paediatric patients, not for minor or chronic pain, and is contraindicated as a prophylactic analgesic before any major surgery.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of ketorolac in pediatric patients 17 years of age and younger have not been established.”

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

  • On older people, the label states: “Exercise caution when treating the elderly (65 years and older) with SPRIX.”

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Use of NSAIDs, including SPRIX, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.”

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including SPRIX, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.”

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

Where the result stopped carrying

  • Dose escalation: three doses spanning a threefold range produced the same analgesia
  • Any use beyond five days: gastrointestinal bleeding risk against opioids more than doubles at that boundary
  • Use in patients already taking aspirin or another NSAID, which is a contraindication rather than a caution
  • Paediatric use and use for minor or chronic pain, both explicitly excluded in the boxed warning
  • Intrathecal and epidural routes, contraindicated because of the formulation’s alcohol content
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Withdrawn

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S8.

No source is stored against this line.

What is in the pack

Given as the tromethamine salt for water solubility.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: The maximum daily injection dose is 120 mg against 40 mg for the oral tablets, and the injection ceiling falls to 60 mg total daily in patients 65 or older, under 50 kg, or with moderately elevated serum creatinine. Oral ketorolac is not a stand-alone product: the label states it is indicated only as continuation treatment following intravenous or intramuscular dosing, with a combined five-day maximum across both routes.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warning covering gastrointestinal, cardiovascular, renal, bleeding, hypersensitivity, route, obstetric and drug-interaction risks. Contraindicated in active or previous peptic ulcer disease or gastrointestinal bleeding; in advanced renal impairment or risk of renal failure from volume depletion; in suspected cerebrovascular bleeding, haemorrhagic diathesis, incomplete haemostasis or high bleeding risk; as a prophylactic analgesic before any major surgery; in the setting of coronary artery bypass graft surgery; in aspirin or NSAID hypersensitivity; for intrathecal or epidural administration because of alcohol content; in labour and delivery; and in patients currently receiving aspirin or any other NSAID. Not indicated in paediatric patients or for minor or chronic painful conditions. Total duration across all routes must not exceed five days.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intravenous and intramuscular injection, oral tablets licensed only as continuation of parenteral dosing, an intranasal spray, and ophthalmic solutions

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

A recorded note compares this form with the others that are sold. It is kept below, word for word.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

The recorded note, unchanged: The maximum daily injection dose is 120 mg against 40 mg for the oral tablets, and the injection ceiling falls to 60 mg total daily in patients 65 or older, under 50 kg, or with moderately elevated serum creatinine. Oral ketorolac is not a stand-alone product: the label states it is indicated only as continuation treatment following intravenous or intramuscular dosing, with a combined five-day maximum across both routes.

No source is stored against this line.

What is recorded as being sold

  • 213 products list this as an active ingredient in the United States drug directory. 209 of them contain it and nothing else.

    FDA National Drug Code directory · 71872-7288 · read 2026-08-29

  • They are sold as injection, injection, solution, injection, solution, concentrate, powder, solution and solution/ drops, taken intramuscular, intraocular, intravenous and nasal.

    FDA National Drug Code directory · 71872-7288 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anti-inflammatory agents, cyclooxygenase inhibitor [epc] and cyclooxygenase inhibitors [moa].

    FDA National Drug Code directory · 71872-7288 · read 2026-08-29

  • 148 published labels name it as an active ingredient. 146 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 2266e650-a0e9-027d-e063-6394a90a795d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 2266e650-a0e9-027d-e063-6394a90a795d · read 2026-08-29

  • Sprix is nasal at 3 DOSAGE FORMS AND STRENGTHS SPRIX (ketorolac tromethamine) Nasal spray: 15.75 mg of ketorolac tromethamine in each 100 μL spray., recorded as fda label in effect 2024-12-05 in the United States.

    US prescribing information · 97005a1c-167e-4676-bae7-e49b38c36f9e · read 2026-08-30

  • Recorded price in US: 0.16585 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 13 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

  • Recorded price in US: 0.49805–12.71006 USD per one millilitre, across 40 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine, withdrawn medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Ketorolac studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That ketorolac is pharmacologically as strong as an opioid — the label describes it as opioid-sparing and as indicated for pain requiring analgesia at the opioid level, which is a statement about the setting rather than the molecule

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a higher dose gives better relief, contradicted by both the boxed warning and a randomised three-dose comparison

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That because operative site bleeding was not increased, platelet inhibition is clinically unimportant — the label still contraindicates prophylactic use before major surgery and in incomplete haemostasis

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the observational gastrointestinal figure of 11.50 transfers to a community outpatient setting, when the exposed population is postoperative and hospitalised

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Ketorolac are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

A randomised trial confirmed the ceiling the label had asserted for decades
In plain words
Ketorolac’s boxed warning has always said that raising the dose will not work better and will cause more harm. In 2017 someone tested it: 10 mg, 15 mg and 30 mg into a vein relieved pain identically in 240 emergency patients.
What was measured
Pain reduction on a numeric rating scale at 30 minutes across intravenous doses of 10, 15 and 30 mg, with rescue analgesia rates
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The randomised double-blind trial enrolled 240 patients aged 18 to 65 presenting with moderate to severe acute pain (numeric rating scale 5 or above), 80 per dose group, excluding peptic ulcer disease, gastrointestinal haemorrhage, renal or hepatic insufficiency, NSAID allergy, pregnancy, and extremes of blood pressure or pulse. Mean baseline pain scores were 7.7, 7.5 and 7.8 in the 10, 15 and 30 mg groups, improving to 5.1, 5.0 and 4.8 at 30 minutes, with overlapping confidence intervals (4.5 to 5.7, 4.5 to 5.6 and 4.2 to 5.4) and no difference between groups. Rescue analgesia rates were similar, adverse effect rates were similar — most commonly dizziness, nausea and headache — and there were no serious adverse events. The authors’ conclusion is that intravenous ketorolac at the analgesic ceiling dose of 10 mg provided effective relief. This is the rare case of a boxed-warning assertion — "increasing the dose beyond the label recommendations will not provide better efficacy but will increase the risk of developing serious adverse events" — being tested prospectively and holding.
Source
Motov S, Yasavolian M, Likourezos A, et al. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med 2017;70:177-184; ketorolac tromethamine prescribing information, boxed warning
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The five-day rule comes from a 20,519-course study, and the risk doubles at day six
In plain words
The famous five-day limit is not arbitrary. A surveillance study across 35 hospitals compared ten thousand courses of ketorolac with ten thousand matched courses of injectable opioid: within five days the bleeding difference was marginal; beyond five days it more than doubled.
What was measured
Adjusted odds ratio for gastrointestinal and operative site bleeding against parenteral opiates, stratified by age, dose and duration
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The postmarketing surveillance inception cohort study covered 10,272 courses of parenteral ketorolac and 10,247 courses of a parenteral opiate, matched by hospital, admitting service and start date, across 35 hospitals in the Philadelphia region between 1991 and 1993. The multivariate adjusted odds ratio comparing ketorolac with opiates was 1.30 (95% CI 1.11 to 1.52) for gastrointestinal bleeding and 1.02 (0.95 to 1.10) for operative site bleeding. In patients aged 75 or older both rose — gastrointestinal bleeding 1.66 (1.23 to 2.25), operative site bleeding 1.12 (0.94 to 1.35). A dose-response relationship was evident between average daily dose and both bleeding endpoints (trend test P<0.001 for both). Duration was decisive for gastrointestinal bleeding and irrelevant for operative site bleeding: at five days or fewer the odds ratio was 1.17 (0.99 to 1.30), and beyond five days it was 2.20 (1.36 to 3.57). The authors concluded that the overall associations were small but that risk becomes clinically important at higher doses, in older patients and beyond five days. That sentence is the boxed warning, and it is unusual for a labelling restriction to have a study this specific behind it.
Source
Strom BL, Berlin JA, Kinman JL, et al. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding: a postmarketing surveillance study. JAMA 1996;275:376-382
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The highest gastrointestinal complication risk of any NSAID here, by a wide margin
In plain words
In the pooled analysis of observational studies, ketorolac’s risk of serious upper gastrointestinal complications was 11.50 times that of non-use — second only to a drug withdrawn from most markets, and more than six times ibuprofen’s.
What was measured
Pooled adjusted relative risk of upper gastrointestinal complications against non-use, by individual NSAID
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The SOS project meta-analysis of 28 observational studies ranked individual NSAIDs by pooled adjusted relative risk of upper gastrointestinal complications against non-use. The range ran from 1.43 for aceclofenac to 18.45 for azapropazone. Ketorolac came second highest at 11.50 (95% CI 5.56 to 23.78), above piroxicam at 7.43 and far above indometacin 4.14, naproxen 4.10, meloxicam 3.47, diclofenac 3.34, ibuprofen 1.84 and celecoxib 1.45. The confidence interval is wide, reflecting how few studies capture a drug used mostly in hospital for short courses, and the estimate carries the confounding-by-indication problem in an acute form — ketorolac is given to postoperative and severely injured patients whose baseline bleeding risk is not that of a community NSAID user. Even discounting heavily for both, this is the drug in this file whose gastrointestinal warning is most firmly grounded, and the label reflects it with an absolute contraindication in active or previous peptic ulcer disease or gastrointestinal bleeding.
Source
Castellsague J, Riera-Guardia N, Calingaert B, et al. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf 2012;35:1127-1146
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The contraindication list is the longest of any drug in this file, and it is specific
In plain words
Most NSAID labels warn. This one forbids: before major surgery, alongside any other NSAID or aspirin, in labour, in children, into the spine, in anyone with a bleeding tendency or advanced kidney disease.
What was measured
Labelled contraindications, population exclusions and dose ceilings against the corresponding warnings in other NSAID labels
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The boxed warning contraindicates ketorolac in active peptic ulcer disease, recent gastrointestinal bleeding or perforation and any history of either; in advanced renal impairment and in patients at risk of renal failure from volume depletion; in suspected or confirmed cerebrovascular bleeding, haemorrhagic diathesis, incomplete haemostasis and high bleeding risk; as a prophylactic analgesic before any major surgery; in the setting of coronary artery bypass graft surgery; in previously demonstrated hypersensitivity to ketorolac or allergic manifestations to aspirin or other NSAIDs; for intrathecal or epidural administration, because of the formulation’s alcohol content; in labour and delivery, because it may adversely affect fetal circulation and inhibit uterine contractions; and in patients currently receiving aspirin or NSAIDs, because of cumulative risk. It further states the drug is not indicated for paediatric patients and not indicated for minor or chronic painful conditions, and sets a reduced injection ceiling of 60 mg total daily for patients 65 or older, under 50 kg, or with moderately elevated serum creatinine. Each of these is a place where an ordinary NSAID would carry a caution and this one carries a prohibition — a reasonable proxy for how much drug a parenteral dose actually delivers.
Source
Ketorolac tromethamine United States prescribing information, boxed warning and Indications and Usage (openFDA drug label endpoint, ANDA 074802)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
"As strong as morphine" is a route effect, and the label does not say it
In plain words
Ketorolac is often described as being as powerful as morphine. What its label actually says is that it is for pain requiring analgesia at the opioid level and that it has an opioid-sparing effect — which is a different and weaker claim.
What was measured
That ketorolac is pharmacologically equivalent to an opioid analgesic — an inference from the clinical setting in which it is used, which the label describes as opioid-sparing rather than opioid-equivalent
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Indications section states that ketorolac is indicated for the short-term management of moderately severe acute pain that requires analgesia at the opioid level, that it has been used concomitantly with morphine and meperidine and shown an opioid-sparing effect, and that for breakthrough pain the lower end of the ketorolac dosage range should be supplemented with low doses of narcotics as needed. None of that asserts equivalence to an opioid; it describes a drug used in a setting where an opioid would otherwise be, alongside one when needed. At the enzyme ketorolac is not extraordinary — it is a non-selective cyclooxygenase inhibitor like ibuprofen. What is extraordinary is the plasma concentration a parenteral dose reaches, which is why the maximum daily injection dose is 120 mg against 40 mg orally, and why the same molecule is an unremarkable eye drop and a boxed-warning drug in a syringe. Reading the parenteral effect as intrinsic potency leads directly to the error the boxed warning was written to prevent: escalating the dose for inadequate relief.
Source
Ketorolac tromethamine United States prescribing information, Indications and Usage and boxed warning (openFDA drug label endpoint, ANDA 074802)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
It did not increase surgical site bleeding — and that finding is often forgotten
In plain words
Surgeons frequently avoid ketorolac for fear of bleeding at the operation site. In the 20,519-course study that fear was not borne out: the odds ratio for operative site bleeding was 1.02, essentially identical to opioids.
What was measured
Adjusted odds ratio for operative site bleeding, ketorolac against parenteral opiates, overall and in patients aged 75 or older
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the postmarketing surveillance study the multivariate adjusted odds ratio for operative site bleeding comparing ketorolac with parenteral opiates was 1.02 (95% CI 0.95 to 1.10) — no detectable increase — against 1.30 (1.11 to 1.52) for gastrointestinal bleeding. In patients aged 75 or older it rose to 1.12 (0.94 to 1.35), still not significant. Two qualifications keep this from being a licence: a dose-response relationship with average daily dose was evident for operative site bleeding as well as gastrointestinal bleeding (trend test P<0.001 for both), and the label separately contraindicates ketorolac as a prophylactic analgesic before any major surgery and in incomplete haemostasis. So the correct reading is narrow — postoperative ketorolac at licensed doses was not associated with more surgical bleeding in this cohort — rather than a general statement that platelet inhibition does not matter. This audit is included because an evidence audit that only reports findings unfavourable to a drug is not an audit either.
Source
Strom BL, Berlin JA, Kinman JL, et al. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding: a postmarketing surveillance study. JAMA 1996;275:376-382
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 146 documents were read for this substance.

    RNAWiki source record

  • 118 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 108 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 54 of them state the same tMax, and they agree.

    RNAWiki source record

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S8.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 64 approved applications cover products containing this substance. The earliest was NDA019698, approved 19891130 to ROCHE PALO.

    Drugs@FDA application register · NDA019698 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA019698 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19921109.

    FDA National Drug Code directory · 71872-7288 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

3 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A parenteral non-selective NSAID licensed for no more than five days, whose own boxed warning states that exceeding the recommended dose will not improve efficacy but will increase serious harm — a claim a 240-patient randomised trial confirmed by finding 10 mg, 15 mg and 30 mg intravenously identical at 30 minutes — and whose pooled observational upper gastrointestinal complication risk of 11.50 is the second highest of any NSAID studied.

Recorded evidence blocks (11)

What did Ketorolac's largest trial (1561 people) and its longest (11 years) measure?


1561 people in Ketorolac's largest registered study, 11 years in its longest registered window, measuring Maximum Observed Plasma Concentration (Cmax). ClinicalTrials.gov · 2026-09-01

143 phase4, 58 phase2, 51 phase3, 45 na, 31 phase1, 14 early phase1, 3 na or unstated; NCT01260883; 2010-12. Last human test completed 2026, NCT05776953.

Interpretation These counts include studies where Ketorolac was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase4
    143
  • phase2
    58
  • phase3
    51
  • na
    45
  • phase1
    31
  • early phase1
    14
2 more recorded rows
  • na or unstated
    3
  • Last recorded human test NCT05776953
    2026-08-12

recorded 2026-09-01 · last checked 2026-09-04

From C. elegans to human: where has Ketorolac shown lifespan?


C. elegans: lifespan, mouse: mechanism-only, rat: mechanism-only and human: biomarker (333): the rungs where Ketorolac has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Maximum Observed Plasma Concentration (Cmax) — the recorded outcome words.

Yeast C. elegans lifespanDrosophila Mouse mechanism-onlyRat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • C. elegans
    lifespan
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • human NCT01355588
    biomarker; Maximum Observed Plasma Concentration (Cmax); 333

recorded 2026-09-01 · last checked 2026-09-04

50 of Ketorolac's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?


futility/efficacy (3), accrual/recruitment (21), funding/business (6) and other (20): Ketorolac's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Poor accrual"; 50 of 333 registered studies

Show the evidence

Trial

  • NCT00115336
    terminated; "Poor accrual"
  • NCT00349401
    withdrawn; "Study was not initiated. No subjects were screened or enrolled."
  • NCT00478036
    terminated; "insufficient enrollment"
  • NCT00621530
    terminated; "Terminated due to discontinuation of Acular PF (investigational medication)"
  • NCT00634972
    terminated; "The study could not be completed as the company producing this product interrupted their supply of this medication"
  • NCT00693160
    terminated; "the manufacturing of preservative free ketorolac (Acular-PF) was discontinued"
14 further recorded trials
  • NCT01133639
    terminated; "PI no longer with the institution, funding issues, poor accrual"
  • NCT01374828
    withdrawn; "lack of funding"
  • NCT01449448
    withdrawn; "PI didn't have time to finish approval process"
  • NCT01498796
    terminated; "PI no longer at institution"
  • NCT01534806
    withdrawn; "Drug is backordered;"
  • NCT01609881
    withdrawn; "Due to lack of funding"
  • NCT01736358
    terminated; "Interim analysis showed futility of primary endpoint"
  • NCT02266433
    terminated; "due to PI's change to private practice"
  • NCT02297906
    terminated; "Enrolment issues"
  • NCT02400645
    terminated; "It was determined that one member of the team had falsified data."
  • NCT02465138
    withdrawn; "Lack of Funding"
  • NCT02570503
    terminated; "Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable."
  • NCT02571283
    withdrawn; "PI decided to focus on more current topics of interest."
  • NCT02765815
    withdrawn; "competing protocol"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Ketorolac used Ketorolac 30 mg — over how long?


studies of Ketorolac used the recorded amount. ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; IV, ophthalmic; also "Ketorolac 30 mg", "KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC", "ketorolac 0.5%"

Show the evidence

human

  • NCT00293631
    Ketorolac 30 mg
  • NCT00478036
    KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
  • NCT00485108
    ketorolac 0.5%
  • NCT00634972
    Acular LS 0.4% 5 mL
  • NCT00791323
    Ketorolac 0.4%
  • NCT00974753
    Ketorolac 0.5%
14 more recorded rows
  • human NCT01001806
    Ketorolac Tromethamine 0.45%
  • human NCT01260883
    Ketorolac Tromethamine 1 mg/kg
  • human NCT01260883
    Ketorolac Tromethamine 0.5 mg/kg
  • human NCT01355588
    Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)
  • human NCT01355588
    Ketorolac Tromethamine with 5% Lidocaine HCl
  • human NCT01355588
    30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
  • human NCT01609881
    Ketorolac 0.45%
  • human NCT01806259
    IV; Ketorolac 30 mg IV
  • human NCT02078492
    10 mg of Ketorolac
  • human NCT02078492
    15 mg of Ketorolac
  • human NCT02078492
    30 mg of Ketorolac
  • human NCT02082067
    Ketorolac 30mg
  • human NCT02646072
    ophthalmic; Ketorolac tromethamine ophthalmic solution 0.45%
  • human NCT02681211
    Ketorolac 0.5mg/kg, max 30mg

recorded 2026-09-01 · last checked 2026-09-04

Ketorolac's half-life is 2.5 hours — which schedules were studied?


2.5 hours, the half-life Ketorolac's label states. openfda-label · 59d86768-6214-8389-e063-6394a90a0a3d · 2026-08-30

Show the evidence
  • half life
    2.5 hours hours; The half-life of the ketorolac tromethamine S-enantiomer was approximately 2.5 hours (SD ± 0.4) compared with 5 hours (SD ± 1.7) for the R-enantiomer.

recorded 2026-08-30 · last checked 2026-09-04

Which of acute pseudophakic cystoid macular edema, analgesic efficacy and aqueous pge2 inhibition did Ketorolac's trials measure?


acute pseudophakic cystoid macular edema, analgesic efficacy and aqueous pge2 inhibition lead 40 outcome terms across Ketorolac's trials. ClinicalTrials.gov · 2026-09-01

Interpretation time to epithelial closure in each eye after prk, vas pain, satisfaction, interocular pressure, ocular comfort and pain at rest follow.

Show the evidence
  • time to a 50 reduction in reported pain intensity
    1
  • best corrected visual acuity at all study visits
    1
  • degree of corneal haze at all study visits
    1
  • time to epithelial closure in each eye after prk
    1
  • vas pain
    1
  • satisfaction
    1
14 more recorded rows
  • interocular pressure
    1
  • ocular comfort
    1
  • pain at rest
    1
  • acute pseudophakic cystoid macular edema
    1
  • pain
    1
  • opioid consumption
    1
  • pain on movement
    1
  • hyperalgesia
    1
  • pain relief local anti flammatory effects
    1
  • post operative febrile morbidity
    1
  • morphine consumption
    1
  • pain after instilation
    1
  • intraocular pressure
    1
  • intraocular pressure change
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Ketorolac's 40 ongoing trials reports first?


40 registered trials of Ketorolac are open; earliest completion 2020-05-20. ClinicalTrials.gov · 2026-09-01

Clearance (CL) or apparent oral clearance (CL/F); Microneurography (MSNA); latest 2031-09

Show the evidence

Trial

  • NCT03427736
    "Anesthetics and Analgesics in Children"; n 551; "Clearance (CL) or apparent oral clearance (CL/F)"; 2027-09-09
  • NCT03513770
    "Autonomic Control of the Circulation and VDR"; n 18; "Microneurography (MSNA)"; 2027-11-01
  • NCT03638999
    "NSAIDs Stent Study"; n 36; "Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1"; 2027-10
  • NCT03823534
    "Post-Op Pain Control for Prophylactic Intramedullary Nailing."; n 60; "Milligram Morphine Equivalent (MME) of Opioid Medications Utilized"; 2027-03-31
  • NCT03825809
    "Nonopioid Analgesia After Labral Surgery"; n 100; "Pain Levels"; 2020-05-20
  • NCT04130464
    "Intraperitoneal Infusion of Analgesic for Postoperative Pain Management"; n 120; "Pain Level 1 Hour Postoperative"; 2026-12
14 further recorded trials
  • NCT04205916
    "A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery"; n 50; "Patient Preference"; 2020-12-01
  • NCT04771156
    "Ketorolac in Palatoplasty"; n 74; "Volume of oral intake"; 2027-04-01
  • NCT05019638
    "Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures"; n 200; "Visual Analog Scale (VAS) pain"; 2028-05
  • NCT05037812
    "Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures"; n 150; "Visual Analog Scale (VAS) pain"; 2028-03
  • NCT05336266
    "A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma"; n 28; "Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days."; 2026-12-05
  • NCT05488847
    "Opioid-Free Pain Protocol After Shoulder Arthroplasty"; n 83; "Pain Levels"; 2026-09-01
  • NCT05543785
    "Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries"; n 76; "The postoperative analgesic duration"; 2027-12-30
  • NCT05842044
    "NSAID Use After Robotic Partial Nephrectomy"; n 110; "Rate of Opioid Use in Postoperative Period"; 2026-09-30
  • NCT05992883
    "NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis"; n 240; "Visual Analogue Scale (VAS) of Pain"; 2026-12-31
  • NCT06081101
    "Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain"; n 20; "Sacroiliac (SI) joint pain"; 2026-06
  • NCT06150898
    "Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)"; n 112; "To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac"; 2027-10
  • NCT06158620
    "Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease"; n 80; "Change in pain scores as measured by USSQ Pain Survey"; 2027-12-01
  • NCT06160778
    "Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain"; n 495; "Pain relief as measured on the verbal numerical rating scale"; 2029-12
  • NCT06201676
    "Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients"; n 458; "Chronic Opioid Use"; 2027-08-31

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Ketorolac could settle inflammatory markers?


NCT06150898 measures To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac, reading out 2027-10.

1 open trial; n 112; "Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)"

Show the evidence
  • Trial NCT06150898
    "Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)"; n 112; "To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac"; 2027-10

Which 102 trials of Ketorolac posted no result?


Posted no result
102 of 102 completed trials
Registrations
NCT00845754, NCT02642718, NCT01356212, NCT00293631, NCT00161577 and NCT00347204, and 96 more
Completion dates
oldest 2001-08; newest 2024-08-15
Show the evidence

Trial

  • NCT00845754
    2001-08
  • NCT02642718
    2001-11
  • NCT01356212
    2002-12
  • NCT00293631
    2006-03
  • NCT00161577
    2006-06
  • NCT00347204
    2006-06
14 further recorded trials
  • NCT01347853
    2007-06
  • NCT01363063
    2007-06
  • NCT00366691
    2007-09
  • NCT00504283
    2007-10
  • NCT00576329
    2007-10
  • NCT00548678
    2007-11
  • NCT01363089
    2008-02
  • NCT00520260
    2008-08
  • NCT00405262
    2008-10
  • NCT00603083
    2008-10
  • NCT00595543
    2009-03
  • NCT00785863
    2009-04
  • NCT00707421
    2009-05
  • NCT01103401
    2010-01

At the median, Ketorolac's trials enrolled 70 people — anything larger?


Median enrolment
70
Largest enrolment
1561
Registered trials counted
333

Was Ketorolac studied with exercise?


exercise is named in Ketorolac's label sentences: "In Trial 1, the first 5 min served as control exercise (CON), followed by 5 min of L-NMMA or ketorolac over the last 5 min of exercise." openfda-label+europepmc · 2015-03-28

1 recorded statement; exercise

Show the evidence
  • exercise
    In Trial 1, the first 5 min served as control exercise (CON), followed by 5 min of L-NMMA or ketorolac over the last 5 min of exercise.

recorded 2015-03-28 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
181818
CAS number
66635-93-6
InChIKey
OZWKMVRBQXNZKK-LLVKDONJSA-N
Salt form
Ketorolac Tromethamine
Trade name
Toradol, Acular, Acuvail, Sprix, Acular Ls, Toronova II Suik, Toronova SUIK, Toradol, Sprix (intranasal), Acular and Acuvail (ophthalmic), Omidria
Also called
1H-PYRROLIZINE-1-CARBOXYLIC ACID, 5-BENZOYL-2,3-DIHYDRO-, (R)-, R-(+)-KETOROLAC
Sources (9)

Sources

3 more sources
  • openfda-label 59d86768-6214-8389-e063-6394a90a0a3d ·
  • openfda-label+europepmc K1:10A5O25ILE ·
  • national registers US, CA ·

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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