🏛️ Verified NIH Record • Updated 2026-05-13

Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients (NCT06201676)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Massachusetts General Hospital

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (16 items).

Location: Massachusetts General Hospital — Boston, Massachusetts

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Massachusetts General Hospital — Boston, Massachusetts
  • Vanderbilt University Medical Center — Nashville, Tennessee

📞 Contact the Study Coordinator

Phone: (617) 726-6546

Email: aaneja@mgh.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗