NCT00344045已完成4 期
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2006年4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
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- 24-hour cumulative dose of tramadol
研究概览
简要总结
The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal anesth
- •BMI 10-35
- •No pain conditions/concom med may alter pain quantif.
排除标准
- •Other add. surgery
- •Liver/Renal function altered
- •coagulation alterations
- •Respir / Cardiac insufficiency
- •Agents affecting microsomal syst
研究组 & 干预措施
A
Active Comparator
干预措施: Paracetamol (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
24-hour cumulative dose of tramadol
时间窗: 24 hours, defining TO as the start time of the first dose of study drug
次要结局
- Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs.(24 hours, defining TO as the start time of the first dose of study drug)
研究者
研究点 (1)
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