Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Faces Pain scale - revised
研究概览
简要总结
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen
干预措施: Ibuprofen (Drug)
Oral morphine
干预措施: Oral morphine (Drug)
结局指标
主要结局
Faces Pain scale - revised
时间窗: 30 minutes post intervention compared to baseline
The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.
次要结局
- Acetaminophen doses(24 hours)
研究者
Naveen Poonai
Principal Investigator
Lawson Health Research Institute