Comparison of Analgesic Effects of Nalbuphine and Buprenorphine on Caudal Ropivacaine in Children Undergoing Infraumbalical surgery: - A Prospective Randomised Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia
研究概览
简要总结
CAudal epidural analgesia is a very common method of providing analgesia for children undergoing surgeries. It can be used for providing both intraoperative and post operative analgesia. A lot of adjuvant drugs are available for proving extended duration of post operative analgesia when mixed along with local anesthetic for caudal epidural. Ropivacaine is a long acting local anesthetic which in a concentration of 0.2% provides sensory block without motor blockade. Buprenorphine and Nalbuphine are synthetically derived opioids which provide analgesia without risk of respiratory depression due to its agonist-antagonist properties. the primary purpose of our study is to find out which among the two (nalbuphine and buprenorphine) is a better adjuvant when compared to each other and with plain ropivacaine in terms of duration of post operative analgesia, sedation, and incidence of side effects.
Primary hypothesis : -Nalbuphine is a better adjuvant than buprenorphine when given through epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries
Alternative Hypothesis : - Buprenorphine is a better adjuvant than nalbuphine when given through caudal epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •weight between 3- 20 kilograms American Society of Anesthesiologists physical status 1 and 2 undergoing infraumbalical surgeries under general anesthesia supplemented with caudal epidural analgesia.
排除标准
- •patients having neurological, neuromuscular and coagulation disorders 2) patients having infection or deformity at site of caudal epidural injection 3) patients with known allergy to the study drugs.
结局指标
主要结局
Time to first rescue analgesia
时间窗: Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery
次要结局
- Sedation score
- Degree of motor blockade(Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery)
- Incidence of side effects(Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery)