NCT00508495已完成3 期
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 8
- 主要终点
- Amount of PCA-administered morphine consumed during first six hours of study drug treatment
研究概览
简要总结
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
- •Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.
排除标准
- •Another acute or chronic painful physical condition
- •Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
- •Inability to use and understand Visual Analog Scale and Verbal Rating Score
研究组 & 干预措施
Test drug
Experimental
干预措施: Paracetamol 1% solution (Drug)
Reference drug
Active Comparator
干预措施: Paracetamol (acetaminophen) (Drug)
Placebo
Placebo Comparator
干预措施: 0.9% sodium chloride solution (Drug)
结局指标
主要结局
Amount of PCA-administered morphine consumed during first six hours of study drug treatment
时间窗: 6 hours from first (of four) study drug doses
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental PainPain, PostoperativeNCT00406679Baxter Healthcare Corporation135
已完成
3 期
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to OsteoarthritisPainOsteoarthritisNCT00833794Labopharm Inc.1,028
已完成
3 期
Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)Knee OsteoarthritisNCT00264225Solvay Pharmaceuticals
已完成
3 期
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common ColdPharyngitisCommon ColdTonsillitisNCT01361399Bayer1,088
已完成
3 期
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol HydrochlorideAcute PainNCT01902134Menarini Group641