NCT03635398Unknown不适用
Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sedation level
研究概览
简要总结
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •every child >1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair
排除标准
- •Active respiratory infection
- •systemic illness
- •Allergy to Midazolam
研究组 & 干预措施
Intranasal Midazolam by SipNose device
Experimental
干预措施: Sipnose device (Device)
Intranasal Midazolam by MAD (Mucosal Atomization Device)
Active Comparator
干预措施: MAD (Mucosal Atomization Device) (Device)
oral administration of midazolam
Active Comparator
干预措施: midazolam (Drug)
结局指标
主要结局
Sedation level
时间窗: within 60 minute
measured by RAMSAY SEDATION SCALE
Anexiety level
时间窗: within 60 minute
measured by modified PREOPERATIVE ANXIETY SCALE (YALE)
次要结局
未报告次要终点
研究者
研究点 (1)
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