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临床试验/NCT00130104
NCT00130104已完成4 期

Transthecal Metacarpal Block vs Traditional Digital Block for Painful Finger Procedures in Children

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
92
试验地点
2
主要终点
Success of the two types of digital blocks

研究概览

简要总结

The purpose of this study is to determine if the transthecal metacarpal block is superior to the traditional digital block for regional digital anesthesia in children.

详细描述

Background: Finger injuries and infections are common presenting problems in the pediatric emergency department. A traditional digital block, requiring at least two injections of anesthetic, is the traditional method of regional anesthesia for many finger procedures. Digital blocks can sometimes be difficult to administer and assess for effectiveness especially in children. A newer procedure, the transthecal metacarpal block, may be easier to administer, and more effective with one injection.

Objective

To determine if the transthecal metacarpal block (MCB) provides superior digit anesthesia in children requiring painful finger procedures as compared to the traditional digital block (TDB).

Methods: A randomized clinical trial comparing the MCB to the TDB will be conducted in an urban, tertiary care pediatric emergency department. Children <18 years of age, presenting to the emergency department with a finger injury or infection, which requires regional anesthesia for repair will be screened for eligibility. Eligible patients, with appropriate consent will be randomized to receive either the MCB or TDB with 1% Lidocaine. The primary outcome, success of the block will be assessed using pinprick testing after a standardized wait time. Secondary outcomes including pain with the block and repair, repairing physician satisfaction, and short-term complications will also be assessed.

Implications: Finding successful methods of anesthesia and pain control are paramount in the pediatric emergency department. In addition, using a type of digital block which is easy to administer, successful, and requires only one injection would give physicians confidence to treat finger injuries in children with regional anesthesia and possibly avoid procedural sedation in some cases. To date, no studies have been published on the efficacy of digital blocks in children. This study will also serve to give baseline success rates for both types of digital blocks.

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
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age <18 years
  • Greater than 10 kg in weight
  • Have finger injuries or infections that will require digital regional anesthesia
  • Require only local anesthesia for the repair
  • English speaking

排除标准

  • Have previous participation in this study
  • Need procedural sedation at the onset of the repair
  • Have allergy to lidocaine or amide-type local anesthetics
  • Have infection at the sites of block injection
  • Have known coagulopathy

结局指标

主要结局

Success of the two types of digital blocks

时间窗: immediate

次要结局

  • Pain experienced with the digital block(immediate)
  • complications associated with digital block(30 days)
  • Repairing physician satisfaction with the procedure(immediate)

研究者

申办方类型
Other

研究点 (2)

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