Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- time until sedation is achieved
研究概览
简要总结
Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.
A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 5 months to 6 years.
- •need to undergo a minimal invasive procedure that requires light sedation.
- •ASA (American Society of Anesthesiologists) I-II
- •parent that can read, understand and sign an informed consent form
排除标准
- •patients with life threatening conditions.
- •patients with respiratory or cardiac chronic illnesses or ASA other than I-II.
- •patients with traumatic injury for the nose or the oral cavity.
- •patients that would not or cannot take the drug in the route picked in a randomized way.
研究组 & 干预措施
oral midazolam
oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
干预措施: Midazolam (Drug)
intranasal midazolam
intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
干预措施: Midazolam (Drug)
buccal midazolam
buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
干预措施: Midazolam (Drug)
结局指标
主要结局
time until sedation is achieved
时间窗: 1 hour
duration of sedation
时间窗: 4 hour
time from achieving sedation until reaching full consciousness
convenience of administration
时间窗: 15 minutes
described by the parent and the physician by a numerical rating scale (NRS) questionaire
efficacy of the sedation
时间窗: 4 hours
described by the parent, nurse and physician by a NRS questionaire
次要结局
未报告次要终点
研究者
Muriel Konopnicki
Head of Pediatric emergency room
Carmel Medical Center