CTRI/2025/12/099174尚未招募3 期
A Randomised Control Trial comparing the Efficacy and Safety of Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine for Procedural Sedation in children aged 5-14 years.
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Depth of Sedation
研究概览
简要总结
The index Clincal trial "Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine in Children aged 5-14 years for Procedural Sedation" will be a Randomised Control Trial and is being registered in Clinical Trial Registry of India will be carried out in Department of Paediatrics PGIMS Rohtak with complete adherence to Clinical Trial protocols PI Dr. Kapil Bhalla , Co PI Dr. Bhaviya . The trial results will be avaliable in public domain and any clinical deviation if any, will be duly reported. Total duration of trial will be 9 months from the date of generation of ctri number
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5 -14 years having ASA physical status 1 and 2 as per ASA guidelines.
排除标准
- •1-Any known allergy to drug 2- Children having Severe Liver or Renal Insufficiency 3- Severe bradycardia or atrioventricular block above II degree type 2 4- Children whose parents refuse to give consent.
结局指标
主要结局
Depth of Sedation
时间窗: 120 minutes or till clinical recovery.
次要结局
- Time of recovery from sedation(30,45,60,75,90,105,120 minutes)
研究者
Dr Kapil Bhalla
Department of Paediatrics
研究点 (1)
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