Effect of single shot intravenous dexmedetomidine for the supplementation of caudal analgesia in children - a prospective randomized comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AIIMS
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of intravenous dexmedetomidine on caudal analgesia , to compare the time to rescue analgesia.
研究概览
简要总结
Dexmedetomidine is a short acting selective alpha 2 agonist with sedative anxiolytic and analgesic properties. It has been used as adjunct to general and regional anaesthesia in adults.In adults, there are studies showing analgesic action of Intravenous dexmedetomidine on epidural block.
After a vast literature search ,we found that there are limited studies on the effect of intravenous dexmedetomidine on caudal analgesia in children. We hypothesis that intravenous dexmedetomidine might prolong the caudal analgesia in children. Hence we planned to conduct this study to evaluate the efficacy of intravenous dexmedetomidine for the supplementation of caudal analgesia in children.
the study results is statistically significant increase duration of analgesia with dexmedetomidine group of mean duration 425 minutes and that of saline group of 300 minutes
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 8.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I-II Age 2- 8 yrs Undergoing urethroplasty.
排除标准
- •Parental or guardian refusal Hypersensitivity to any local anaesthetic Bleeding diathesis Infection at puncture site Children with uncorrected heart disease Children with heart block or liver impairment Preexisting neurological diseases.
结局指标
主要结局
To assess the effect of intravenous dexmedetomidine on caudal analgesia , to compare the time to rescue analgesia.
时间窗: The duration of analgesia is from the time of caudal injection to the time of FLACC score 4.
次要结局
- To compare the incidence of emergence agitation(To compare the time for discharge based on modified aldrete score.)