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临床试验/NCT00333346
NCT00333346已完成2 期

Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
200
试验地点
2
主要终点
Time course of pain relief

研究概览

简要总结

The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I and II female or male patients
  • Aged 18-70 years
  • Scheduled for ambulatory surgery requiring postoperative pain medication.

排除标准

  • Weight less than 70% or more than 130% of ideal body weight
  • Neurological disorder
  • Recent use of psycho-active medication, including alcohol
  • Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
  • Use of chronic anti-emetic medication, use of chronic corticoid therapy

结局指标

主要结局

Time course of pain relief

Accuracy of pain relief

Onset of side-effects

Duration of side-effects

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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