Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to first analgesic rescue medication
研究概览
简要总结
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.
However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.
In order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. However, their use has been limited by adverse effects in children.
Recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. But there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.
The investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.
80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.
After discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h.
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA status I-II
- •Children aged 6 months to 5 years
- •Undergoing day-case unilateral orchiopexy
排除标准
- •Hypersensitivity to any local anesthetics
- •Bleeding diathesis
- •Infections at puncture sites
- •Preexisting neurological disease
- •Diabetes mellitus
研究组 & 干预措施
Group R
Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered.
干预措施: Caudal block (Procedure)
Group DR
Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.
干预措施: Caudal block (Procedure)
结局指标
主要结局
Time to first analgesic rescue medication
时间窗: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
次要结局
未报告次要终点
研究者
Jeong-Rim LEE
Assistant Professor
Yonsei University
