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NCT07430345PHASE1, PHASE2Recruiting

Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department

The Cooper Health System

Start Date

5/7/2026

Completion Date

1/1/2027

Summary

The goal of this clinical trial is to learn if buprenorphine can treat pain in older adults who have broken bones. The main questions it aims to answer are: Is buprenorphine as effective as opioids to treat pain? Are there less side effects with buprenorphine? Researchers will compare buprenorphine and hydromorphone to see if there are differences in pain control and side effects. Participants will be given one of the two study drugs after breaking a bone and asked about their pain scores and side effects for the next 48 hours.

Detailed Description

Older adults are prone to fractures but are less likely to receive adequate analgesia in the Emergency Department (ED)due to concerns for side effects including respiratory depression, sedation, delirium, and constipation, however untreated pain can induce delirium, decrease satisfaction, and impede functional recovery. Buprenorphine is a partial opioid agonist with analgesic properties, does not require dosing changes in renal or hepatic insufficiency, and may have a ceiling on respiratory depression. Prior studies have demonstrated similar or improved efficacy compared to full agonist opioids in treating acutely painful conditions, however older adults are underrepresented or excluded as a population in this research and have unique considerations due to polypharmacy, comorbidities, and aging physiology, leaving a gap in knowledge for this population. This proposal will test the hypothesis that buprenorphine is a feasible intervention that is as effective as full-agonist opioids for the treatment of acute pain in older adults but with reduced adverse drug events, with the long-term goal to improve pain control in older adults in acute settings. Demonstrating safety of buprenorphine to manage older adults experiencing acute pain could improve emergency care, reduce adverse events associated with full agonist opioids, and improve patient satisfaction.

Eligibility Criteria

Age Range: 65 years to No maximum

Inclusion Criteria: * Age 65 years or older * Emergency Department patient * Diagnosis of suspected or confirmed acute fracture * Numerical Rating Scale 4 or greater at time of presentation * Must be able to give informed consent or have a surrogate decisionmaker to provide informed consent * Subjects who may require a surgical procedure are eligible for enrollment, as given the low dose of buprenorphine, this is not anticipated to affect future anesthesia. If additional pain control is needed for surgical procedure, full agonist opioid can be used without contraindication. Exclusion Criteria: * Prior history of opioid use disorder * Participants taking chronic opioid therapy (defined as opioids taken during the past month) * Allergy to study medications * Hemodynamic instability requiring immediate resuscitation * Inability to consent and absence of surrogate decisionmaker

Interventions

DRUG

Buprenorphine 0.15 MG

DRUG

Hydromorphone 0.25 mg IV

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Conditions

Fracture

Locations

Cooper University Hospital

Camden, New Jersey 08103

United States