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