Condition: Orthopaedic Trauma · Chronic Opioid Use · Sponsor: Massachusetts General Hospital
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 trauma patients. The main questions this study aims to answer are: 1. Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone? 2. Does scheduled ketorolac during the first five days of the perioperative period 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 the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. 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 comp…
This description comes directly from the study's public registry record.
Arun Aneja, MD, PhD · 617-726-6546 · aaneja@mgh.harvard.edu
Healy S. Vise, BS · 617-643-1232 · hvise@mgh.harvard.edu
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| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06201676