CTRI/2021/04/032662尚未招募3 期
Comparison of intranasal dexmedetomidine and ketamine for paediatric premedication: A randomized study.
Neha Kumari1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月26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
- 100
- 试验地点
- 1
- 主要终点
- FLACC scoring
研究概览
简要总结
Comparison of intranasal dexmedetomidine and ketamine for paediatric premedication. This will enable us to decide the optimum drug for having a calm child before surgery. The study will include 100 paediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •patients able to comprehend and willing to participate.
- •Patients of ASA physical status 1 and 2.
排除标准
- •patients with known sensitivity to given drugs.
- •patients on concomitant anti arrhythmic or sedative medication.
- •patients with history of nausea/vomiting, apnoeic spells,cardiorespiratory and neurological illnesses.
结局指标
主要结局
FLACC scoring
时间窗: 45 minutes
次要结局
- Preoperative anxiety score, acceptance of intranasal delivery, sedation score and any adverse effect.(60 minutes)
研究者
研究点 (1)
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