Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT06819956
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06819956
Study Brief:
Protocol Section:
NCT06819956