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临床试验/CTRI/2026/03/105433
CTRI/2026/03/105433招募中2 期

amnesic effect of oral midazolam and intranasal dexmedetomidine in children: a randomized clinical study

pooja nellore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
amnesic effect of midazolam compared to dexmedetomidine.

研究概览

简要总结

To evaluate the amnestic effect of oral midazolam using amnesia test.

To evaluate the amnestic effect of intranasal dexmedetomidine using amnesia test.

To compare the amnestic effect of oral midazolam and intranasal dexmedetomidine.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • ASA category.
  • 1 childs weight within normal range frankls positive or negative behavior children with at least 2 carious lesions.

排除标准

  • children with identifiable risk factors for airway obstruction, such as enlarged tonsils or adenoids, nasal polyps, septal deviation and a mallampati score of 3 or 4.

结局指标

主要结局

amnesic effect of midazolam compared to dexmedetomidine.

时间窗: assessed every 15 minutes till the procedure ends.

次要结局

  • ramsay sedation scoring(15 minutes after administration of the drug)

研究者

发起方
pooja nellore
申办方类型
Other [Postgraduate student]
责任方
Principal Investigator
主要研究者

pooja nellore

Manipal College of Dental Sciences Mangalore

研究点 (1)

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