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临床试验/NCT00287326
NCT00287326终止3 期

Comparison of Epidural Bupivacaine-Clonidine With Intravenous Morphine Versus Intravenous Morphine Alone for Post-Operative Pain Relief in Pediatric Patients Undergoing Lower Extremity or Pelvic Osteotomy.

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
40
试验地点
2
主要终点
24 hour recording of pain, sedation, narcotic usage, and satisfaction.

研究概览

简要总结

The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

详细描述

Post-operative pain in patients undergoing osteotomy can be severe. Current methods of treatment involve parenteral narcotics and regional anesthesia. Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. However, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). Parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. Further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).

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

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Elective lower extremity osteotomy
  • Expected length of stay greater than 24 hours

排除标准

  • History of previous spine surgery
  • Current infection overlying catheter insertion site
  • Coagulopathy

结局指标

主要结局

24 hour recording of pain, sedation, narcotic usage, and satisfaction.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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