NCT07430345

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
6mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

February 18, 2026

Last Update Submit

April 20, 2026

Conditions

Fracture

Keywords

buprenorphinegeriatricanalgesia

Outcome Measures

Primary Outcomes (1)

  • Difference in pain scores

    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

    4 hours

Secondary Outcomes (5)

  • Number of patients with adverse events

    48 hours

  • Number of patients requiring naloxone

    4 hours

  • Number of patients who receive rescue medications

    4 hours

  • Total oral morphine equivalents

    8 hours

  • Mortality

    30 days

Study Arms (2)

Hydromorphone

ACTIVE COMPARATOR

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

Drug: Hydromorphone 0.25 mg IV

Buprenorphine

EXPERIMENTAL

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

Drug: Buprenorphine 0.15 MG

Interventions

Buprenorphine 0.15 MGDRUG

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

Buprenorphine
Hydromorphone 0.25 mg IVDRUG

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

Hydromorphone

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (9)

  • Selman K, Perelman S, Blatcher C, Fett D, Adams A, Roberts B. Buprenorphine for acute pain in older adults: a systematic review with meta-analysis. Pain Med. 2024 Jul 18:pnae064. doi: 10.1093/pm/pnae064. Online ahead of print.

    PMID: 39024042BACKGROUND

  • Albaqami MS, Alqarni AA, Alabeesy MS, Alotaibi AN, Alharbi HA, Alshammari MM, Aldhfery AH. Buprenorphine for acute post-surgical pain: A systematic review and meta-analysis. Saudi J Anaesth. 2023 Jan-Mar;17(1):65-71. doi: 10.4103/sja.sja_822_22. Epub 2023 Jan 2.

    PMID: 37032687BACKGROUND

  • White LD, Hodge A, Vlok R, Hurtado G, Eastern K, Melhuish TM. Efficacy and adverse effects of buprenorphine in acute pain management: systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2018 Apr;120(4):668-678. doi: 10.1016/j.bja.2017.11.086. Epub 2017 Dec 2.

    PMID: 29576108BACKGROUND

  • Jalili M, Fathi M, Moradi-Lakeh M, Zehtabchi S. Sublingual buprenorphine in acute pain management: a double-blind randomized clinical trial. Ann Emerg Med. 2012 Apr;59(4):276-80. doi: 10.1016/j.annemergmed.2011.10.021. Epub 2011 Nov 23.

    PMID: 22115823BACKGROUND

  • Saini M, Samanta J, Kumar A, Choudhury A, Dhar J, Jafra A, Chauhan R, Muktesh G, Gupta P, Gupta V, Yadav TD, Kochhar R, Capurso G, De-Madaria E, Facciorusso A. Buprenorphine Versus Diclofenac for Pain Relief in Acute Pancreatitis: A Double-Blinded Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):532-541.e8. doi: 10.1016/j.cgh.2023.10.021. Epub 2023 Nov 3.

    PMID: 37924855BACKGROUND

  • Dahan A, Yassen A, Romberg R, Sarton E, Teppema L, Olofsen E, Danhof M. Buprenorphine induces ceiling in respiratory depression but not in analgesia. Br J Anaesth. 2006 May;96(5):627-32. doi: 10.1093/bja/ael051. Epub 2006 Mar 17.

    PMID: 16547090BACKGROUND

  • Boger RH. Renal impairment: a challenge for opioid treatment? The role of buprenorphine. Palliat Med. 2006;20 Suppl 1:s17-23.

    PMID: 16764217BACKGROUND

  • Hale M, Garofoli M, Raffa RB. Benefit-Risk Analysis of Buprenorphine for Pain Management. J Pain Res. 2021 May 24;14:1359-1369. doi: 10.2147/JPR.S305146. eCollection 2021.

    PMID: 34079354BACKGROUND

  • Coe MA, Lofwall MR, Walsh SL. Buprenorphine Pharmacology Review: Update on Transmucosal and Long-acting Formulations. J Addict Med. 2019 Mar/Apr;13(2):93-103. doi: 10.1097/ADM.0000000000000457.

    PMID: 30531584BACKGROUND

MeSH Terms

Conditions

Fractures, BoneAgnosia

Interventions

BuprenorphineHydromorphone

Condition Hierarchy (Ancestors)

Wounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Central Study Contacts

Katherine E Selman, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)