Fracture
Conditions
Keywords
buprenorphine, geriatric, analgesia
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.
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
given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
DRUGHydromorphone 0.25 mg IV
given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pain scores | 4 hours | Difference in pain scores measured on the numerical rating scale, collected on arrival and measured at one hour and four hours after medication administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 48 hours | GI 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. |
| Naloxone use | 4 hours | Need for naloxone administration |
| Rescue medication use | 4 hours | Administration of rescue medications (yes/no) |
| Total oral morphine equivalents | 8 hours | Administered in the ED |
| Mortality | 30 days | Mortality |
Countries
United States
Contacts
CONTACTKatherine E Selman, MD
Outcome results
None listed