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Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis

NCT01739985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.

Conditions

  • Postoperative Vomiting

Interventions

DRUG

Dexamethasone + ondansetron + Placebo

Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1.Administration of the saline 30 minutes before the end of surgery

DRUG

Dexamethasone + ondansetron + Droperidol

Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1Administration of droperidol 30 minutes before surgery at a dose of 50 micrograms.kg-1

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles ORLIAGUET, MD, PhD · Necker Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-07-31
Completion
2014-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739985 on ClinicalTrials.gov