Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06201676 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contacts updated at 1 of 2 sitesv9
  2. Minor Interventions: Ketorolac Injection (Drug), Normal Saline (Other) to Ketorolac Injection (Drug), Standard of Care (SOC) Multimodal Analgesia (Other) Eligibility criteria revised · Study description expanded, about 21 words · Site contacts updated at 1 of 2 sitesv8 Show 3 more changesShow less
    • Eligibility criteria revised
    • Study description expanded, about 21 words
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Eligibility criteria expanded, about 7 wordsv7 See this version in full on ClinicalTrials.gov ↗
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2025 to Feb 28, 2025 · Site details revised at 2 of 2 sitesv6 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2025 to Feb 28, 2025
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Nov 2024 to Jan 2025 Study sites: 1 to 2v5 Show 1 more changeShow less
    • Study sites: 1 to 2
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Jul 1, 2024 to Nov 2024 Study description expanded, about 19 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Start date: May 1, 2024 to Jul 1, 2024v3
  3. Notable Start date: Jan 1, 2024 to May 1, 2024v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06201676
Lead Sponsor Massachusetts General Hospital
Collaborators: United States Department of Defense
Conditions Orthopaedic Trauma, Chronic Opioid Use
Enrollment 458 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov