临床试验/NCT00487110

NCT00487110已完成4 期

Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

University Hospital, Clermont-Ferrand2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2008年6月1日最近更新: 2010年3月29日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 40
试验地点: 2
主要终点: Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

详细描述

The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•More than 18 years
•Men or women
•Ear surgery
•Written consent given

排除标准

•Paracetamol hypersensibility
•Tropisetron hypersensibility

结局指标

主要结局

Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups

时间窗: at 30 min, 1h, 2h, 3h

次要结局

未报告次要终点

研究者

发起方

University Hospital, Clermont-Ferrand

申办方类型

Other

研究点 (2)

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