NCT01298297已完成4 期
Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in pain severity/score
研究概览
简要总结
The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of extremity bone fracture Age>16 years Acute pain of score 3 or greater on numerical rating scale
排除标准
- •Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)
研究组 & 干预措施
Buprenorphine + Placebo
Active Comparator
干预措施: Buprenorphine (Drug)
Morphine + Placebo
Placebo Comparator
干预措施: Morphine (Drug)
结局指标
主要结局
Change in pain severity/score
时间窗: After 60 min
次要结局
- Need for rescue analgesia(After 60 min)
- Occurrence of adverse events(During 60 min)
研究者
研究点 (1)
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