NCT07553000招募中不适用
The Additional Pain Relieving Benefit of Using a Splint in Suspected Wrist Fractures in Adult Patients at an Emergency Department - a Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.
详细描述
Randomized controlled trial of suspected wrist fractures in patients seeking emergency department care. Comparison of pain relief. Randomized to standard care or standard care + aluminium splint.
Primary outcome: Numeric rating scale (NRS) pain rating at 1 hour. Secondary outcomes: Pain medication usage between groups. Negative impact on radiology results.
Safety endpoint: Reported side effects
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected distal fracture of radius
排除标准
- •No X-ray veriefied fracture.
研究组 & 干预措施
SAM splint
Active Comparator
Recieves SAM splint for pain relief
干预措施: SAM splint (Device)
Control
No Intervention
Treatment as usual
结局指标
主要结局
Pain assessment
时间窗: 60 minutes
Self assessed pain according to NRS (numeric rating scale)
次要结局
- Negative impact on radiology(24 hours from enrollment in study.)
- Pain relief medication(24 hours from enrollment.)
- Adverse events(24 from enrollment in ER.)
研究者
研究点 (1)
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