NCT00636428已完成4 期
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Tabriz University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- efficacy and safety of endoscopy in children with used midazolam
研究概览
简要总结
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
详细描述
Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation.
Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of patients scheduled for endoscopy participated in the study.
排除标准
- •Exclusion criteria were as follows:
- •Children younger than 3 years;
- •Children with significant neurological disability;
- •Children with a history of allergies to benzodiazepines, or to their components;
- •Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;
- •Children with respiratory distress
- •Age under 1 mo and bigger than 17y
- •History of erythromycin used in 4 week ago
研究组 & 干预措施
1
Active Comparator
Oral midazolam
干预措施: Midazolam (Drug)
2
Active Comparator
IV Midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
efficacy and safety of endoscopy in children with used midazolam
次要结局
- The level of sedation
- patient complications, ease of performing the procedure, time of preparation, time for recovery
研究者
研究点 (1)
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