Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Total sedation time
研究概览
简要总结
The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English or Spanish speaking
- •Ages 3-17
- •Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
- •Fracture involves the distal third of the forearm
排除标准
- •Multiple trauma victims
- •Associated nerve or vascular damage
- •Associated elbow or humerus injury
- •Sensitivity or allergy to lidocaine
- •Contraindications to procedural sedation
- •Previous attempts at reduction for the same injury
研究组 & 干预措施
Lidocaine
Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.
干预措施: Lidocaine (Drug)
Normal Saline
Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site
干预措施: Saline (Drug)
结局指标
主要结局
Total sedation time
时间窗: Evaluated upon completion of procedure
次要结局
- Non-union(1 month)
- Need for re-manipulation(1 week)
- Adverse effects of sedation(For the duration of the procedure)
- Adverse effects of hematoma block(1 month)
- Pain control(For entire duration of procedure)
研究者
Erika Constantine
Clinical Assistant Professor
Rhode Island Hospital
