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临床试验/NCT01869036
NCT01869036已完成4 期

Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery - Prospective Study

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire

研究概览

简要总结

The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal anesthesia in children who undergo renal surgery in our department.

详细描述

The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy.

One of the main goals in the postoperative period is to provide a painless recovery following by early mobilization of the child and early discharge home. Caudal anesthesia has become a gold standard in the renal surgery providing painless postoperative period, allowing earlier child feeding and speedy recovery. However some researchers have pointed out that caudal anesthesia with supplemented with Marcaine may provide painless postoperative period only for a very limited period of time and required additional painkiller therapy during postoperative period. Caudal anesthesia supplemented with Morphine has demonstrated their benefits in children who undergo infraumbilical surgery.

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
Single (Participant)

入排标准

年龄范围
2 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children who are scheduled for renal surgery from two months age to puberty
  • operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy

排除标准

  • malignancy

研究组 & 干预措施

caudal anesthesia supplemented with morphine

Active Comparator

干预措施: caudal anesthesia supplemented with morphine (Drug)

caudal anesthesia

Active Comparator

干预措施: caudal anesthesia (Drug)

结局指标

主要结局

statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire

时间窗: at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)

The following parameters will be compared between two groups: the length of surgery, intraoperative and postoperative narcotic requirements. The children parents or children thyself will be asked to fill out the pain assessment questionnaire.

次要结局

  • Side-effects measuring(during operation and within 1 post-op day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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