Can a common painkiller curb opiate use in the ICU?
NCT ID NCT06819956
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether a low dose of ketorolac, an NSAID, can safely reduce pain and the need for opiates in critically ill ICU patients. Thirty adults with pain will receive either ketorolac or a placebo for up to three days. The main goal is to see if this approach is feasible for a larger future trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketorolac (an NSAID painkiller)
- What this could lead to
- If it works, this could point toward a way to reduce opiate use in the ICU, lowering the risk of addiction after discharge.
- What could go wrong
- This is a small pilot study with only 30 patients, so results may not be definitive. NSAIDs carry risks of bleeding and kidney injury, though patients are closely monitored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \> 18 years * Admission to intensive care unit (ICU) * Participants with pain (Critical Care Pain Observation Tool \[CPOT\] \> 1 and/or self-report pains score \>1 on visual analogue scale \[VAS\] or numerical rating scale \[NRS\]) Exclusion Criteria: * Serum Cr \> 100 mmol/L for females, and \>130 mmol/L for males * Ongoing ACEi (angiotensin converting enzyme inhibitor)/ARB (angiotensin receptor blocker) use in ICU * Known hyperkalemia \> 5.5 * Pre-existing chronic kidney disease (CKD Stage \> 3), defined by a serum Cr \> 100 mmol/L for females, and \>130 mmol/L for males (at the time of screening, based on pre-hospital stable outpatient baseline values) * New acute kidney injury KDIGO Stage \> 2 (increased more than \> 2-to-3 times in serum creatinine above baseline AND/OR \<0.5mL/kg/hour urine output for \>12 hours) * Pre-existing gastrointestinal bleeding (within 12 weeks of hospital admission, requiring hospitalization or medical evaluation), new peptic ulcer disease, esophagitis, esophageal varices within the last 3 months * Active gastric / duodenal / peptic ulcer, active GI bleeding * Prior contraindications/allergies to NSAIDS or stress ulcer prophylaxis, specifically if a participant has had an anaphylactic reaction (asthma or urticaria) or non-anaphylactic asthma reaction to NSAIDs or any stress ulcer prophylaxis, e.g. proton pump inhibitor, histamine-2-blockers, etc. (e.g. proton pump inhibitor, histamine-2-blockers, etc.) * Complete or partial syndrome of ASA-intolerance (e.g. rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) * Participants who are not receiving stress ulcer prophylaxis (e.g. proton pump inhibitor, histamine-2-blockers, etc.) while in ICU * Any active bleeding (requiring any blood products or adjunctive coagulation agents, any output of blood \>100 mL/hr, e.g. chest tube drainage, abdominal cavity drain, etc.) * Currently receiving NSAID(s) for another indication * Inflammatory bowel disease (e.g. participants with prior diagnosis of Crohn's disease or ulcerative colitis) * Receiving probenecid, oxpentifylline or pentoxifylline * Active ischemic heart disease (acute myocardial infarction, acute coronary syndrome during current hospital admission) * Moderate-severe uncontrolled heart failure (New York Heart Association: Class II-IV) * Moderate to severe liver impairment or active liver disease (Operational definition: participants with prior history of Child-Pugh class B (moderate) or C (severe) liver cirrhosis, OR Model for End-Stage Liver Disease-Sodium (MELD-Na) score \>25, OR active acute liver failure: severe acute liver injury with encephalopathy and impaired synthetic function International Normalized Ratio (INR) \>1.5 with or without pre-existing liver disease) * Active cerebrovascular bleeding or stroke (cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax, e.g. participants with active stroke symptoms within current hospital admission) * Cerebrovascular bleeding or other bleeding disorders * Coagulation disorders, post-operative patients with high haemorrhagic risk or incomplete haemostasis in patients with suspected or confirmed cerebrovascular bleeding * Neuraxial (epidural or intrathecal) administration of ketorolac tromethamine injection due to its alcohol content * Rhabdomyolysis (creatinine kinase \>5000 U/L) * Recent transplant (during same hospital admission, e.g., heart, lung, kidney, liver, etc.) * Known allergy to ketorolac or other NSAIDs * Participants expected to stay in ICU \< 48 hours * In the opinion of the attending physician, expected death or withdrawal of life-sustaining treatments within 48 hours * Participant is known to be pregnant and/or breastfeeding * Most responsible physician, participant, or substitute decision maker declines study participation (and reason)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alberta Hospital
RECRUITINGEdmonton, Alberta, T6G 2B7, Canada
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