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临床试验/NCT01604915
NCT01604915已完成不适用

Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy

Yonsei University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2012年5月最近更新:
适应症
干预措施

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

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

Placebo Comparator

Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered.

干预措施: Caudal block (Procedure)

Group DR

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-Rim LEE

Assistant Professor

Yonsei University

研究点 (2)

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