Health TrialsbyHealthPanel

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

ConditionFracture
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe Cooper Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Buprenorphine 0.15 MG

    Drug

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

  • Hydromorphone 0.25 mg IV

    Drug

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: HydromorphoneActive comparator 1 intervention
Group B: BuprenorphineExperimental treatment 1 intervention

Trial outcomes

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

Time frame
4 hours

Secondary outcomes

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.

Time frame
48 hours
2

Number of patients requiring naloxone

Need for naloxone administration

Time frame
4 hours
3

Number of patients who receive rescue medications

Administration of rescue medications (yes/no)

Time frame
4 hours
4

Total oral morphine equivalents

Administered in the ED

Time frame
8 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cooper Health System

Lead sponsor

Source ClinicalTrials.gov
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