跳至主要内容
临床试验/NCT00878345
NCT00878345撤回不适用

Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics

Washington University School of Medicine1 个研究点 分布在 1 个国家开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
failure of sedation

研究概览

简要总结

The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Requiring sedation for non-painful procedures
  • Normal airway per exam

排除标准

  • Congenital syndromes with known difficult airways
  • Known difficult airway during past anesthesia or sedation experience
  • Parent/guardian refusal of participation

研究组 & 干预措施

1

Active Comparator

Dexmedetomidine sedation protocol

干预措施: dexmedetomidine sedation protocol (Drug)

2

Active Comparator

Pentobarbital sedation protocol

干预措施: pentobarbital sedation protocol (Drug)

结局指标

主要结局

failure of sedation

时间窗: day of sedation

次要结局

  • side effect profile(48 hours)
  • post-sedation recovery and discharge time(day of sedation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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