Buprenorphine for pain relief in older adults with broken bones in the ED

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in older adults with suspected or confirmed acute fractures in the emergency department compares buprenorphine and hydromorphone for pain control over 48 hours. It is conducted in two phases (Phase 1 and Phase 2) to assess safety and efficacy in a geriatric population. Buprenorphine is a partial opioid with potential advantages in older patients, including fewer respiratory effects and no dose adjustments for liver or kidney issues. The trial will measure pain scores and adverse events after administration of the two drugs. Eligible participants are adults aged 65 and older seeking ED care for fracture who can consent or have a surrogate decision-maker.

Why it matters

Who can join: the full rules

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

Where it's running

• Cooper University Hospital
  Camden, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Katherine E Selman, MD
• Email: selman-katherine@cooperhealth.edu
• Phone: 856-342-2627

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.