A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Successful reduction
研究概览
简要总结
Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a "clic" or "clunk" is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.
详细描述
The usual therapy consists of one of two maneuvers: supination maneuver or pronation maneuver. They both are safe to perform but none of them have been statistically superior over the other. More studies are needed to confirm or discard the tendency of the studies to favor the pronation maneuver.
The investigators intend to perform a randomized trial evaluating which of these techniques is better than the other in terms of returning the mobility of the affected arm and decreasing pain.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulled elbow suspected in any child presenting one of the following:
- •History of an adult or bigger person that had pulled the child's elbow non-intentionally
- •Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.
排除标准
- •Any suspect of injury that could be intentional (child abuse)
- •Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.)
- •The mechanism was from multiple trauma
- •Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)
结局指标
主要结局
Successful reduction
时间窗: 10 to 20 minutes
✦ Patient can move his/her arm without pain in the next 20 minutes after the technique is applied: i.e., the mother asks the child to hold an object (toy) and the toddler can hold it without problem.
次要结局
- Pain of the procedure(1 to 5 min)
研究者
Carlos Alberto Cuello-Garcia
Director of the Center for Evidence Based Medicine & Knowledge Translation
Instituto Tecnologico y de Estudios Superiores de Monterey