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Recruiting NCT07430345

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

Phase I / Phase II Interventional Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buprenorphine 0.15 MG, Hydromorphone 0.25 mg IV.
Who it may be relevant to
Registry conditions: Fracture. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug Buprenorphine 0.15 MG
    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
    given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses

Primary outcome measures

  • Difference in pain scores [Time frame: 4 hours]
Secondary outcome measures (5)
  • Number of patients with adverse events [Time frame: 48 hours]
  • Number of patients requiring naloxone [Time frame: 4 hours]
  • Number of patients who receive rescue medications [Time frame: 4 hours]
  • Total oral morphine equivalents [Time frame: 8 hours]
  • Mortality [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cooper University Hospital — Camden

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 16547090
  • Boger RH. Renal impairment: a challenge for opioid treatment? The role of buprenorphine. Palliat Med. 2006;20 Suppl 1:s17-23. PMID 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. PMID 34079354

Identifiers

NCT: NCT07430345 · 25-151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗