Actively Recruiting
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Led by Massachusetts General Hospital · Updated on 2026-05-14
458
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a low-dose, short-term use of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), can reduce chronic opioid use in adults with orthopaedic trauma. The trial aims to find out if scheduled ketorolac during the first five days after surgery, combined with standard pain care, lowers the chance of ongoing opioid use six months after injury. The study also investigates if ketorolac improves patients' functional response to pain and how early pain control may affect longer-term opioid use and recovery. Participants are randomly assigned to one of two groups: one receives ketorolac intravenously every six hours for up to five days during the perioperative period, switching to oral ketorolac if discharged early, alongside standard multimodal analgesia (MMA). The other group receives only the standard MMA as per institutional protocols. The study compares these groups to see if ketorolac affects chronic opioid use and pain recovery outcomes. During the study, patients' pain levels and opioid use are tracked daily over the five-day treatment period. Functional pain responses are measured using surveys at hospital discharge and at 2 weeks, 6 weeks, 3 months, and 6 months post-injury. The main outcome is chronic opioid use at six months, with additional assessments including pain inventories, resilience scales, and opioid dose measurements. Participants are followed for at least six months to assess these effects thoroughly.
CONDITIONS
Brief Title
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age between 18 and 70 years
- Patient or legally authorized representative can provide consent
- Acute musculoskeletal trauma requiring surgical fixation
- Anticipated hospital admission
- Ability to speak English or Spanish
- Ability to be followed at the enrolling facility for at least 6 months
You will not qualify if you...
- Patient younger than 18 or older than 70 years
- Injury occurred more than 24 hours before evaluation
- Active hemorrhagic shock or risk of significant bleeding
- Pregnant or breastfeeding
- History of active gastrointestinal bleeding or ulcers
- Chronic use of steroids, immune-modulating drugs, or history of organ transplant
- Preexisting chronic kidney, liver, heart, or lung disease
- Creatinine level of 1.30 mg/dL or higher at enrollment
- History of heart attack, stroke, or bleeding disorder
- Head or chest injury needing surgery
- Allergy to ketorolac or aspirin sensitivity
- Current chronic opioid therapy or treatment for opioid use disorder
- Current intravenous drug use
- Need for daily NSAID or aspirin use, except low-dose aspirin (81 mg)
- Inability to complete follow-up due to death, loss to follow-up, severe psychiatric illness, unstable living situation, planned follow-up elsewhere, distance, or incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days
Participants receive a scheduled five-day course of low-dose ketorolac alongside standard pain management or standard pain management alone after orthopaedic surgery.
Daily visits during hospital stay for up to 5 days
Duration - 6 months
Participants attend follow-up visits to assess pain, function, resilience, and opioid use over 6 months post-injury.
Visits at hospital discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
A
Arun Aneja, MD, PhD
H
Healy S. Vise, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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