Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06819956

Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study

Led by University of Alberta · Updated on 2025-09-23

30

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. This may contribute to the ongoing opiate epidemic across the world. Other medications that can reduce pain, like non-steroidal anti-inflammatory drugs (NSAIDs), are being studied in critically ill patients. These drugs block the enzyme, cyclooxygenases (COX), which causes inflammation in the body. Blocking these enzymes can decrease pain, fever, and inflammation. Traditionally, NSAIDs are not commonly used in critically ill patients due to the perceived risk of gastrointestinal (GI) bleeding and acute kidney injury (AKI). However, many critically ill patients are already receiving medications and treatments to prevent GI bleeding and AKI and are closely monitored so these medications may be useful in reducing pain for these patients. The purpose of this study is to see whether NSAIDs can be used safely in critically ill patients to reduce the dose of opiates required for pain control. This is a pilot study or a feasibility study, which is not expected to answer the question definitively. Its main purpose is to determine if NSAIDs could reduce the use of opiates in critically ill patients while in the ICU. The data collected in this study may be used in a larger study in the future.

CONDITIONS

Official Title

Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Admission to intensive care unit (ICU)
  • Presence of pain with Critical Care Pain Observation Tool (CPOT) score greater than 1 and/or self-reported pain score greater than 1 on visual analogue scale (VAS) or numerical rating scale (NRS)
Not Eligible

You will not qualify if you...

  • Serum creatinine greater than 100 mmol/L for females and greater than 130 mmol/L for males
  • Current use of ACE inhibitors or angiotensin receptor blockers in ICU
  • Known high potassium level (hyperkalemia) above 5.5
  • Chronic kidney disease Stage greater than 3 based on baseline creatinine values
  • New acute kidney injury stage greater than 2 per KDIGO criteria
  • Recent gastrointestinal bleeding or active peptic ulcers within the last 3 months
  • Allergic reactions or intolerance to NSAIDs or stress ulcer prevention medications
  • Not receiving stress ulcer prophylaxis while in ICU
  • Any active bleeding requiring blood products or significant blood loss
  • Current use of NSAIDs for other indications
  • History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  • Use of probenecid, oxpentifylline, or pentoxifylline
  • Active ischemic heart disease or acute coronary syndrome during this hospital stay
  • Moderate to severe uncontrolled heart failure (NYHA Class II-IV)
  • Moderate to severe liver impairment or active liver disease
  • Active cerebrovascular bleeding or recent stroke symptoms
  • Blood clotting disorders or high bleeding risk post-surgery
  • Use of epidural or intrathecal ketorolac injection
  • Rhabdomyolysis with creatinine kinase above 5000 U/L
  • Recent organ transplant during this hospital stay
  • Known allergy to ketorolac or other NSAIDs
  • Expected ICU stay less than 48 hours
  • Expected death or withdrawal of life support within 48 hours
  • Known pregnancy or breastfeeding
  • Declined study participation by patient, physician, or decision maker

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

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Research Team

V

Vincent I Lau, MD MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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