Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

University Hospital, Clermont-Ferrand40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

TropisetronDRUG

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

paracetamolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * More than 18 years * Men or women * Ear surgery * Written consent given Exclusion Criteria: * Paracetamol hypersensibility * Tropisetron hypersensibility

Locations (1)

CHU

Clermont-Ferrand, France

Outcomes

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

Data from ClinicalTrials.gov

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