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

Who can join

Ages 18 to 70 · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient age \< 18 or \> 70 years
* Patients with injury more than 24 hours prior to evaluation
* Patients with active hemorrhagic shock or risk of significant hemorrhage
* Patients who are pregnant or breastfeeding
* Patients with a history of active gastrointestinal bleeds or ulceration
* Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation
* Patients with preexisting chronic renal, liver, heart, or lung disease
* Patients with a creatinine ≥ 1.30 mg/dL during enrollment
* Patients with history of myocardial infarction, stroke, or bleeding disorder
* Patients with head or chest injury requiring surgical intervention
* Patients with allergy to ketorolac or hypersensitivity to aspirin
* Patients receiving chronic opioid therapy or treatment for opioid use disorder
* Patients who are current IV drug users
* Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)
* Patients with insufficient follow-up or anticipated difficulty in completing follow-up at a study site for a minimum of 6 months due to any of the follow reasons: death, no follow-up after initial discharge, severe psychiatric conditions, unstable living conditions, planned follow-up at another medical center not participating in this study, live far away from the clinic, and/or incarcerated

About the study

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.

What is being tested

• Ketorolac Injection (drug)
• Standard of Care (SOC) Multimodal Analgesia (other)

Sponsor: Massachusetts General Hospital · Participants: 458 · Started: Feb 28, 2025

Contact the study team

• Arun Aneja, MD, PhD · Phone: 617-726-6546
• Healy S. Vise, BS · Phone: 617-643-1232

Official record on ClinicalTrials.gov — NCT06201676

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.