Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT06201676

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

130 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Able to provide consent or have a legally authorized representative provide consent
  • Have acute musculoskeletal trauma requiring surgical fixation (such as ORIF or intramedullary nailing)
  • Anticipated hospital admission
  • Speak English or Spanish
  • Able to be followed at the enrolling facility for at least 6 months
Not Eligible

You will not qualify if you...

  • Age under 18 or over 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 bleeds or ulcers
  • Chronic use of steroids or immune-modulating drugs or history of organ transplantation
  • Preexisting chronic kidney, liver, heart, or lung disease
  • Creatinine level greater than or equal to 1.30 mg/dL at enrollment
  • History of heart attack, stroke, or bleeding disorder
  • Head or chest injury requiring surgery
  • Allergy to ketorolac or aspirin hypersensitivity
  • Current chronic opioid therapy or treatment for opioid use disorder
  • Current intravenous drug use
  • Require daily NSAIDs or aspirin, except low-dose aspirin (81 mg)
  • Unable to complete follow-up at study site for at least 6 months due to reasons such as death, no follow-up, severe psychiatric issues, unstable living conditions, planned care elsewhere, distance, or incarceration

AI-Screening

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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

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Research Team

A

Arun Aneja, MD, PhD

CONTACT

H

Healy S. Vise, BS

CONTACT

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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