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临床试验/NCT00763880
NCT00763880终止4 期

Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erika Constantine

Clinical Assistant Professor

Rhode Island Hospital

研究点 (1)

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