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临床试验/NCT01070108
NCT01070108已完成不适用

EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Ketamine affects postoperative pain when administered intravenously immediately before, during or at the end of surgical procedures. We assessed the effects of multiple and escalating doses of ketamine administered many hours before surgery on postoperative pain and analgesia consumption.

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
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia

排除标准

  • allergy to opioids, ketamine or non-steroidal anti-inflammatory drugs (NSAIDs)
  • history of lasting chronic pain or psychiatric disorders or had used opioids or psychotropic drugs of any sort during the past two weeks
  • soldiers and pregnant women

研究组 & 干预措施

Set 1

Active Comparator

group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)

干预措施: ketamine (Drug)

set 2

Active Comparator

2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group

干预措施: ketamine (Drug)

set 3

Active Comparator

3rd set one group had ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS

干预措施: ketamine (Drug)

结局指标

主要结局

postoperative pain

时间窗: 48 hours

次要结局

  • opioid drug consumption(48 hours)

研究者

申办方类型
Other Gov

研究点 (1)

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