Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

Phase 4

Completed

• Conditions: Pain

• Registration Number: NCT00487110
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Study Start: 2008-06
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-26
• Last Update Posted: 2010-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Paracetamol hypersensibility
• Tropisetron hypersensibility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU; 🇫🇷 Clermont-Ferrand, France