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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is researching whether a low dose of ketorolac, a type of pain-relieving medication, can help reduce the long-term use of opioids in patients with severe orthopedic injuries. The study will compare patients who receive ketorolac during their first five days in the hospital to those who receive a placebo, which looks like the medication but doesn't have any active ingredients. The researchers want to find out if those taking ketorolac are less likely to need opioids six months after their injury and if they experience less pain and better recovery during their treatment.

To participate in this trial, individuals must be between 18 and 70 years old and have suffered significant musculoskeletal injuries that require surgery. Patients should also be able to communicate in English or Spanish and be willing to attend follow-up visits for at least six months. During the study, participants will receive either ketorolac or placebo every six hours for five days while in the hospital. They will have their pain and use of opioids tracked daily and will also complete surveys about their pain at several points after being discharged. This trial is still recruiting, and it aims to provide valuable information on managing pain and reducing reliance on opioids after serious injuries.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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