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临床试验/NCT07045597
NCT07045597已完成不适用

Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
sedative effect of preanesthetic Midazolam

研究概览

简要总结

This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.

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
None

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •pediatric patient of age 2-6 y
  • •ASA I-II children
  • •child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy

排除标准

  • •Parent refusal .
  • •Allergy to any of the drug included in this study
  • •Nasal infection , allergy and pathology
  • •Mentally affected children , neurological disable .
  • •Blood disesases and any other contraindications of surgery

研究组 & 干预措施

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

Placebo Comparator

Patient will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group

干预措施: intranasal normal saline for preanasthetic sedation for Adenotonsillectomy (Drug)

intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

Active Comparator

Patient will receive intranasal midazolam by dose 0.2 mg/kg

干预措施: intranasal midazolam for preanasthetic sedation for Adenotonsillectomy (Drug)

结局指标

主要结局

sedative effect of preanesthetic Midazolam

时间窗: 5 minutes,10 minutes and 15 minutes preoperative

Glasgow coma scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ramadan Hassan

Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Sohag University

研究点 (1)

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