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临床试验/NCT00949780
NCT00949780已完成2 期

Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

Pontificia Universidade Catolica de Sao Paulo2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
36 patients slept

研究概览

简要总结

Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in pediatric and dental procedures owing to the low depressive effect it has over respiratory and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and sudden death in children, especially when using high doses, probably due to accumulation of serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the drug. A possible carcinogenic action observed in guinea pigs has also been reported, even though it has not been confirmed in human beings.

Among the least severe complications there are paradoxical agitation, nausea, vomiting and excessive sleepiness.

CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test (ABR), in which any movement or muscle contraction may generate artifacts that interfere in the analysis.

Profound sleep that lasts on average one hour is rapidly induced depending on the used dose, causing no residual sleepiness after this period; however, there is consensus in the literature about the best dose, which may range from 40 to 100 mg/kg.

Objective:

To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
1 Year 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • no success in previous attempts to perform the test during natural sleep

排除标准

  • severe heart or lung disease

研究组 & 干预措施

chloral hydrate , sedative

Active Comparator

干预措施: Chloral Hydrate (Drug)

结局指标

主要结局

36 patients slept

时间窗: one hour

次要结局

未报告次要终点

研究者

发起方
Pontificia Universidade Catolica de Sao Paulo
申办方类型
Other

研究点 (2)

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