Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in pain scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Hydromorphone
0.25mg hydromorphone IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
干预措施: Hydromorphone 0.25 mg IV (Drug)
Buprenorphine
0.15mg buprenorphine IV given every 15 minutes as needed for numerical pain score 4 or greater for a maximum of three doses
干预措施: Buprenorphine 0.15 MG (Drug)
结局指标
主要结局
Difference in pain scores
时间窗: 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
次要结局
- Number of patients with adverse events(48 hours)
- Number of patients requiring naloxone(4 hours)
- Number of patients who receive rescue medications(4 hours)
- Adverse events(48 hours)
- Naloxone use(4 hours)
- Rescue medication use(4 hours)
- Total oral morphine equivalents(8 hours)
- Mortality(30 days)
研究者
Katherine Selman
Assistant Professor of Emergency Medicine
The Cooper Health System