Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487110

Acronym

Tropisétron

Enrollment

Registered

2007-06-15

Start date

2008-06-30

Completion date

2009-06-30

Last updated

2010-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, serotonin, interaction, Patients with postsurgical pain, after ear surgery

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.

Interventions

DRUGTropisetron

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

DRUGparacetamol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Paracetamol hypersensibility * Tropisetron hypersensibility

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026