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NCT06201676 · ClinicalTrials.gov registry record · Phase 4
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
A Phase 4 study of Chronic Opioid Use and Orthopaedic Trauma, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 458
- Enrollment target
- 2
- Study locations
NCT06201676 is a Phase 4 study of Chronic Opioid Use and Orthopaedic Trauma that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 458 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06201676, a Phase 4 study of Chronic Opioid Use and Orthopaedic Trauma, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 458 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ketorolac Injection
- OTHER Standard of Care (SOC) Multimodal Analgesia
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06201676
The ClinicalTrials.gov registry entry for NCT06201676 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 458 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which Ketorolac Injection is the first listed.
NCT06201676 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06201676 about?
NCT06201676 is a clinical study titled "Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients". 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 ke...
What is the current status of trial NCT06201676?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 458 participants. The study started on 2025-02-28. Estimated completion is 2027-08-31.
What conditions does trial NCT06201676 study?
This clinical trial studies the following conditions: Chronic Opioid Use, Orthopaedic Trauma.
What interventions are being tested in trial NCT06201676?
The interventions under investigation include: Ketorolac Injection (DRUG), Standard of Care (SOC) Multimodal Analgesia (OTHER).
Who is sponsoring clinical trial NCT06201676?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06201676 being conducted?
This trial has 2 study locations across Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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