CTRI/2025/10/096551尚未招募2/3 期
To Compare the Effectiveness and Safety of Melatonin versus Triclofos Sodium in Procedural Sedation of Children
Dr Ruchika Myrtle Calton1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月10日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- compare time taken to achieve effective sedation
研究概览
简要总结
To compare the effectiveness and safety of the drugs Melatonin and Triclofos Sodium in the procedural sedation of children. Oral form of each medications will be given to respective groups of equal number of participants and the quality and time required to achieve sedation will be recorded. also, the vital monitoring of participants will be done after giving drug, once sedation is achieved and during the procedure to assess the safety profile of the drugs.
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
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3 to 18 years of age.
- •Children posted for elective procedures (BERA, EEG, and CT scan).
排除标准
- •Children with Weight less than 5 Kilograms.
- •High risk children defined by ASA-PS Score more than or equal to
- •History of adverse events during prior sedation with either of the study drugs.
- •Invasive procedures such as biopsies and aspirations or tapping.
- •requiring long sedation.
- •Children already on sedation for ventilation.
结局指标
主要结局
compare time taken to achieve effective sedation
时间窗: level of sedation monitoring to be done for each 5 minute for one hour after giving drug.
次要结局
- compare the safety profile of both the drugs(vital monitoring to be done for each 5 minute for one hour after giving drug. then for each 5 minute for one hour after sedation achieved.)
研究者
Ruchika Myrtle Calton
Christian Medical College Ludhiana
研究点 (1)
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