Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Difference in pain score between groups
研究概览
简要总结
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.
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
- 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
- 否
入选标准
- •ASA I and II female or male patients undergoing wisdom teeth extraction
- •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
研究组 & 干预措施
1
Tramadol per os (Tradonal Odis® orodispersible tablets)
干预措施: Tramadol per os (Tradonal Odis® orodispersible tablets) (Drug)
2
Tramadol IV (Tradonal® IV)
干预措施: Tramadol IV (Tradonal® IV) (Drug)
结局指标
主要结局
Difference in pain score between groups
时间窗: In the first hours after anaesthesia and surgery
次要结局
- Difference in side-effects between the groups(In the first hours after anaesthesia and surgery)