Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Paracetamol hypersensibility
Tropisetron hypersensibility

Treatment and study plan

tropisetron

Drug

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

Paracetamol

Drug

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

Primary outcomes

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

Time frame: at 30 min, 1h, 2h, 3h

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: Tropisétron

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Jun 15, 2007
Registry last updated: Mar 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed