Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol (Tropisétron)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Tropisetron; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT00487110

CHU63-0021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Paracetamol hypersensibility
• Tropisetron hypersensibility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind