NCT01255904已完成4 期
A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to Complete Study
研究概览
简要总结
The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.
排除标准
- •Patients younger than 6 months or older than 8 years
- •Previously failed sedation
- •Weight greater than 25 kg
- •Weight less than 5 kg
- •BMI above 30
- •Diagnosis of ADHD
- •Any patient deemed inappropriate for nurse administered sedation
- •Patients with any cardiac disease
- •Obstructive sleep apnea
研究组 & 干预措施
Arm 1
Experimental
Oral Chloral and intranasal placebo
干预措施: Chloral Hydrate (Drug)
Arm 1
Experimental
Oral Chloral and intranasal placebo
干预措施: Intranasal placebo (Other)
Arm 2
Experimental
oral placebo and intranasal dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Arm 2
Experimental
oral placebo and intranasal dexmedetomidine
干预措施: Oral placebo (Other)
结局指标
主要结局
Time to Complete Study
时间窗: 60-180 minutes
Time from medication administration to study completion.
次要结局
未报告次要终点
研究者
Jason Reynolds
Assistant Professor of Pediatrics
Baylor College of Medicine
研究点 (1)
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