Low-Dose Ketorolac for Multiple Trauma
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic polytrauma patients. The main questions this study aims to answer are:1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo?2. Does scheduled ketorolac during the first five hospital days improve functional responses to pain at discharge, 3 months, and 6 months after injury?3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?Participants will be enrolled and randomized to either the ketorolac (treatment) group or placebo group to be given every 6 hours during the first five hospital days. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.Researchers will compare ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain.
Who Is on the Research Team?
Arun Aneja, MD, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for orthopaedic polytrauma patients with multiple injuries who may be at risk of developing chronic opioid use. Participants must not have conditions that prevent NSAID use, such as certain bleeding disorders, kidney failure, or known allergies to ketorolac.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 15 mg of intravenous ketorolac or placebo every 6 hours during the first five hospital days, in addition to standard of care multimodal analgesia
Follow-up
Participants are monitored for opioid use and functional response to pain at discharge, 2 weeks, 6 weeks, 3 months, and 6 months post-injury
Long-term Follow-up
Participants' chronic opioid use is assessed at 6 months post-injury
What Are the Treatments Tested in This Trial?
Interventions
- Ketorolac
Ketorolac is already approved in United States, European Union, Switzerland for the following indications:
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Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
United States Department of Defense
Collaborator