Recruiting
Phase 1
Phase 2

Buprenorphine vs. Hydromorphone

Sponsor:

The Cooper Health System

Code:

NCT07430345

Conditions

Fracture

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine 0.15 MG

Hydromorphone 0.25 mg IV

Study Details

Brief 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.

Conditions

Fracture

Study ID

NCT07430345

Start date

May 7, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hydromorphone

0.25mg hydromorphone IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses

experimental: Buprenorphine

0.15mg buprenorphine IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses

Interventions

Buprenorphine 0.15 MG

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

Hydromorphone 0.25 mg IV

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

Primary outcome measure

  • Difference in pain scores [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Katherine E Selman, MD

856-342-2627selman-katherine@cooperhealth.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Katherine Selman, MD

856-342-2627selman-katherine@cooperhealth.edu

More Information

Sponsor

The Cooper Health System

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • buprenorphine
  • geriatric
  • analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2026-06-29.