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New treatment option for Pain Management
Official title Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study
ClinicalTrials.gov ID: NCT06819956
What this study is testing
What is Ketorolac?
Ketorolac is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain management.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Opiates are commonly used to control pain in critically ill patients in the ICU. However, increased rates of opiate use in hospital may lead to increased prescription-based opiate dependence after leaving the ICU.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- New acute kidney injury KDIGO Stage \> 2 (increased more than \> 2-to-3 times in serum creatinine above baseline AND/OR \ 12 hours)
- Pre-existing gastrointestinal bleeding (within 12 weeks of hospital admission, requiring hospitalization or medical evaluation), new peptic ulcer...
See the full eligibility 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])
- 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 \ 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.