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NCT Number: NCT07430345

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

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location status: Recruiting

Location contact

Katherine Selman, MD

CONTACT

[email protected]

856-342-2627

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buprenorphine 0.15 MG

Drug

given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses

Hydromorphone 0.25 mg IV

Drug

given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses

Primary outcomes

  1. Difference in pain scores

    Time frame: 4 hours

    Difference in pain scores measured on the numerical rating scale (scale of 0-10, with 10 being maximum pain and 0 being no pain), collected on arrival and measured at one hour and four hours after medication administration

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: 48 hours

    Gastrointestinal symptoms such as nausea, vomiting, constipation, and diarrhea, including by inferring from antiemetic administration; respiratory depression; and delirium. Delirium will be assessed at least 8 hours after enrollment and first dose of medication and within 48 hours. Presence of delirium is determined by a positive Brief Confusional Assessment Method (bCAM) screen. Patients will also be interviewed about other adverse effects at the time of delirium assessment.

  2. Number of patients requiring naloxone

    Time frame: 4 hours

    Need for naloxone administration

  3. Number of patients who receive rescue medications

    Time frame: 4 hours

    Administration of rescue medications (yes/no)

  4. Total oral morphine equivalents

    Time frame: 8 hours

    Administered in the ED

  5. Mortality

    Time frame: 30 days

    Mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine E Selman, MD

CONTACT

[email protected]

856-342-2627

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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