Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study
ConditionPain Management
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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])
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
DrugKetorolac 15 mg IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The ketorolac will be diluted in a 0.9% normal saline 10 mL syringe.
Placebo
DrugMatching placebo IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The matching placebo will be diluted in a 0.9% normal saline 10 mL syringe.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: KetorolacExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Recruitment and Retention
Recruitment rate at pilot site (participants/month), consent rates of eligible participants, proportion of eligible participants not randomized, and participant retention rates.
Time frame
Days 1-7, 902
Feasibility - Protocol Adherence
Rates of protocol adherence and reasons for protocol non-adherence.
Time frame
Days 1-7, 90Secondary outcomes
1
Opioid Use
The administration of opioid medications (converted into oral morphine equivalents)
Time frame
Baseline; Days 1-7, 14, 21, 28, 902
Pain Scores - Critical Care Pain Observation Tool (CPOT)
The critical care pain observation tool (CPOT) is used by healthcare workers to measure four indicators of pain: facial expression, body movements, muscle tension, and compliance with the ventilator (or vocalization for extubated participants). Each of the four indicators are ranked from 0 to 2, with higher numbers describing more pain behaviors.
Time frame
Baseline; Days 1-7, 14, 21, 283
Pain Scores - Visual Analog Scale (VAS)
The visual analog scale (VAS) is a self-reported measure of a participant's level of pain. This tool consists of a single, 10cm long line, with one end titled "No pain" and the other end titled "Pain as bad as it could possibly be." The participant then draws a mark on the line that corresponds to their level of pain. This mark is later quantified in distance from the "no pain" side of the line.
Time frame
Baseline; Days 1-7, 14, 21, 284
Pain Scores - Numerical Pain Rating Scale (NRS)
The numerical pain rating scale (NRS) is a self-reported measure of a participant's level of pain. Participants are asked to rank their pain on a scale of 0 to 10, with 0 representing no pain, and 10 representing the worst possible pain.
Time frame
Baseline; Days 1-7, 14, 21, 28Sponsors and contacts
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Source ClinicalTrials.gov