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Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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 compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patient age: 18-70

• Patient or legally authorized representative (LAR) able to provide consent

• Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and/or intramedullary nailing)

• Anticipated hospital admission

• Patients who speak English or Spanish

• Patients who can be followed at the enrolling facility for at least 6 months

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Arun Aneja, MD, PhD
aaneja@mgh.harvard.edu
617-726-6546
Backup
Adam N Musick, MD
adamnmusick@gmail.com
423-765-3223
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 458
Treatments
Experimental: Standard of Care (SOC) + Ketorolac
The treatment arm will receive a scheduled five-day course of low-dose ketorolac in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol. Ketorolac will be administered intravenously at a dose of 15 mg every 6 hours during the perioperative period. Participants discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours.
Active_comparator: Standard of Care (SOC)
The control arm will receive standard of care (SOC) multimodal analgesia according to each site's institutional protocol.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov