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

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.

Conditions

Orthopaedic Polytrauma, Chronic Opioid Use

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Orthopaedic Polytrauma
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient age: 18-70
  • * Patient or legally authorized representative (LAR) able to provide consent
  • * Patients with NISS \> 9 at time of admission with musculoskeletal trauma requiring surgical fixation
  • * Anticipated admission ≥ 5 days
  • * Patients who speak English or Spanish
  • * Patients who can be followed at our facility for at least 6 months
  • * Patient age \< 18 or \> 70 years
  • * Patients with injury more than 24 hours prior to evaluation
  • * 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 infarctions, stroke, or bleeding disorder
  • * Patients with head or chest injury requiring surgical intervention
  • * Patients with allergy to ketorolac or hypersensitivity to aspirin
  • * Patients receiving chronic opioid therapy or treatment for opioid use disorder
  • * Patients with insufficient follow-up:
  • * Death
  • * No follow-up after initial discharge
  • * Patients who have difficulty maintaining follow-up for clinic visits, including:
  • * Severe psychiatric conditions,
  • * Unstable living conditions,
  • * Planned follow-up at another medical center not participating in this study,
  • * Live far away from the clinic, and/or
  • * Incarcerated
  • * Patients who are current IV drug users
  • * Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)
  • * Patients with hospital length of stay greater than 14 days

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

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

Study Record Dates

2027-08-31