AzTrials
AzTrials

FracturePhase 1/2NCT07430345

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

A Phase 1/2 study testing Buprenorphine 0.15 MG and Hydromorphone 0.25 mg IV in people with Fracture, run by Cooper Norcross Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Fracture
What is being tested?
Buprenorphine 0.15 MG and Hydromorphone 0.25 mg IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
7 May 2026to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katherine E Selman, MD contact

856-342-2627

selman-katherine@cooperhealth.edu

United States1 site, 1 recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Katherine Selman, MD, 856-342-2627, selman-katherine@cooperhealth.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Fracture
Being tested
Buprenorphine 0.15 MG, Hydromorphone 0.25 mg IV
Keywords
buprenorphine, geriatric, analgesia
Medical subject headings
Fractures, Bone, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine 0.15 MGDrug

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

  • Hydromorphone 0.25 mg IVDrug

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

Study groups in NCT07430345
Study groupRoleWhat they receive
HydromorphoneActive comparator0.25mg hydromorphone IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
Receives: Drug: Hydromorphone 0.25 mg IV
BuprenorphineExperimental0.15mg buprenorphine IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
Receives: Drug: Buprenorphine 0.15 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 hours

Secondary outcomes (5)

  1. Number of patients with adverse events

    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.

    Measured: 48 hours

  2. Number of patients requiring naloxone

    Need for naloxone administration

    Measured: 4 hours

  3. Number of patients who receive rescue medications

    Administration of rescue medications (yes/no)

    Measured: 4 hours

  4. Total oral morphine equivalents

    Administered in the ED

    Measured: 8 hours

  5. Mortality

    Mortality

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start7 May 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07430345
Sponsor's protocol ID
25-151
Status last verified
Jun 2026
First submitted
18 Feb 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: There is not a plan to make individual participant data collected in this study available at this time given the small sample size. The authors may be contacted at any time to discuss further.

Publications

  • 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 Dec 1;25(12):691-702. doi: 10.1093/pm/pnae064.

    PubMed 39024042

  • 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.

    PubMed 37032687

  • 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.

    PubMed 29576108

  • 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.

    PubMed 22115823

  • 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.

    PubMed 37924855

  • 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.

    PubMed 16547090

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

    PubMed 16764217

  • 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.

    PubMed 34079354

  • 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.

    PubMed 30531584

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Buprenorphine 0.15 MG and Hydromorphone 0.25 mg IV in people with Fracture, run by Cooper Norcross Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katherine E Selman, MD (856-342-2627, selman-katherine@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in pain scores (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07430345, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in