Comparison of levobupivacaine tramadol with levobupivacaine clonidine in caudal block in children undergoing infraumbilical surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- time duration of analgesia in the post operative period
研究概览
简要总结
The study will be comparing the effect of drug combinations given in caudal block analgesia for the post operative pain relief in the patients. The patients will be children in the age group of 2 to 10 years who will be randomly allocated into 3 groups which will be receiving a particular combination of the drugs. Group I - Levo Bupivacaine 0.25% 1 ml/kg , Group II - Levo Bupivacaine 0.25% 1ml/kg + tramadol 1mg/kg and Group III - Levo bupivacaine 1 ml/kg + Clonidine 1ug/kg after administration of general anaesthesia but before the start of surgery. Outcome will be measured as haemodynamic stability measured in terms of HR, MAP every 5, 10, 15, 30, 45, 60 and 90 mins intra operatively till the completion of the surgery and then duration of post operative analgesia in these patients measured with the help of CHIPPS score and Ramsay sedation score and also hemodynamic parameters at 1 hour interval till the 6th hour and then at 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •children in ASA status 1 and 2 undergoing any type of surgical procedure in the lower abdominal region.
排除标准
- •ASA status 3,4 or 5 Any contraindication to caudal block such as scaral agenesis, tumors, local infection history of seizures hypersensitivity to any of the drugs in the study.
结局指标
主要结局
time duration of analgesia in the post operative period
时间窗: time duration of analgesia in the post operative period measured at 5, 10, 15,30,45,60,90 minutes
次要结局
- hemodynamic stability in the intra operative period(5,10,15,30,45,60,90 intra operatively)