Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The overall postoperative consumption of analgesics.
研究概览
简要总结
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
详细描述
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urogenital pediatric surgery
- •Status physical(ASA) 1 and 2
排除标准
- •Cutaneous infection in puncture site
研究组 & 干预措施
B
compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
干预措施: Bupivacaine (Drug)
C
compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
干预措施: Clonidine (Drug)
M
compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
干预措施: Morphine (Drug)
CM
compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
干预措施: Bupivacaine plus clonidine and morphine (Drug)
结局指标
主要结局
The overall postoperative consumption of analgesics.
时间窗: 24 hours
次要结局
- The peroperative consumption of volatile anesthetics.(3 hours)
- The peroperative Bispectral Index measure.(3 hours)
- Postoperative Wong-Baker faces scale(24 hours)
- Postoperative pain and discomfort score scale(24 hours)