Comparison of caudal bupivacaine and dexmedetomidine with caudal bupivacaine and intravenous dexmedetomidine for post operative analgesia in children.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare caudal and intravenous dexmedetomidine for prolongation of post operative analgesia in children undergoing elective surgeries using FLACC scale
研究概览
简要总结
This study is randomized participant blinded parallel group study comparing two groups of 48 children each undergoing elective surgeries. One group is given caudal bupivacaine and caudal dexmedetomidine and other group is given caudal bupivacaine and intravenous dexmedetomidine .The study will be conducted in VMMC and Safdarjung Hospital,New Delhi . The primary objective of the study is post operative analgesia in children undergoing elective surgeries using FLACC scale and secondary objective of the study is intraoperative haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologists physical status I-II Age 1 to 8 year old children.
- •Scheduled for elective surgery.
排除标准
- •Infection at the site of block.
- •Coagulopathy.
- •Pre-existing neurological or spinal disease and abnormalities of the sacrum.
- •Allergy to local anaesthetics.
结局指标
主要结局
To compare caudal and intravenous dexmedetomidine for prolongation of post operative analgesia in children undergoing elective surgeries using FLACC scale
时间窗: Measuring post operative analgesia using FLACC score and Ramsay sedation score at 1 2 4 8 12 24hrs after surgery
次要结局
- To compare the intra operative haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route(Monitoring baseline HR BP SPO2 preoperatively)