Cooper University Hospital
Camden, New Jersey, 08103, United States
Location status: Recruiting
NCT Number: NCT07430345
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 1 / Phase 2
Camden, New Jersey, 08103, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
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
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.
Time frame: 4 hours
Need for naloxone administration
Time frame: 4 hours
Administration of rescue medications (yes/no)
Time frame: 8 hours
Administered in the ED
Time frame: 30 days
Mortality
Contact information is provided by the study sponsor or research team.
The Cooper Health System
Other
Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study
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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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