RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 polytrauma patients. The main questions this study aims to answer are: 1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo? 2. Does scheduled ketorolac during the first five hospital days 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 placebo group to be given every 6 hours during the first five hospital days. 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 ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain.

Official Title

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

Quick Facts

Study Start:2025-02-28
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06201676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age: 18-70
  2. * Patient or legally authorized representative (LAR) able to provide consent
  3. * Patients with NISS \> 9 at time of admission with musculoskeletal trauma requiring surgical fixation
  4. * Anticipated admission ≥ 5 days
  5. * Patients who speak English or Spanish
  6. * Patients who can be followed at our facility for at least 6 months
  1. * Patient age \< 18 or \> 70 years
  2. * Patients with injury more than 24 hours prior to evaluation
  3. * Hemorrhagic shock or risk of significant hemorrhage
  4. * Patients who are pregnant or breastfeeding
  5. * Patients with a history of active gastrointestinal bleeds or ulceration
  6. * Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation
  7. * Patients with preexisting chronic renal, liver, heart, or lung disease
  8. * Patients with a creatinine ≥ 1.30 mg/dL during enrollment
  9. * Patients with history of myocardial infarctions, stroke, or bleeding disorder
  10. * Patients with head or chest injury requiring surgical intervention
  11. * Patients with allergy to ketorolac or hypersensitivity to aspirin
  12. * Patients receiving chronic opioid therapy or treatment for opioid use disorder
  13. * Patients with insufficient follow-up:
  14. * Death
  15. * No follow-up after initial discharge
  16. * Patients who have difficulty maintaining follow-up for clinic visits, including:
  17. * Severe psychiatric conditions,
  18. * Unstable living conditions,
  19. * Planned follow-up at another medical center not participating in this study,
  20. * Live far away from the clinic, and/or
  21. * Incarcerated
  22. * Patients who are current IV drug users
  23. * Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)
  24. * Patients with hospital length of stay greater than 14 days

Contacts and Locations

Study Contact

Arun Aneja, MD, PhD
CONTACT
617-726-6546
aaneja@mgh.harvard.edu
Adam N Musick, BS
CONTACT
617-643-1232
anmusick@mgh.harvard.edu

Principal Investigator

Arun Aneja, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Arun Aneja, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • orthopaedic polytrauma
  • chronic opioid use
  • NSAID
  • IV ketorolac
  • acute pain management

Additional Relevant MeSH Terms

  • Orthopaedic Polytrauma
  • Chronic Opioid Use