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

Not Applicable

Completed

• Conditions: Postoperative Vomiting
• Interventions: Drug: Dexamethasone + ondansetron + Droperidol; Drug: Dexamethasone + ondansetron + Placebo

• Registration Number: NCT01739985
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

The overall incidence of postoperative vomiting between 25 and 30% for the pediatric population, but it can reach a much higher incidence associated with certain types of surgery, about 80% in some studies like strabismus surgery for example. The identification of patients at high risk of POV is possible through the use of risk score. It is currently only one pediatric validated risk score, but the investigators conducted a multicenter study on this subject, whose results are being analyzed. This should allow us to identify children at high risk of POV. In this targeted population, the prophylaxis should allow a significant reduction in the incidence of POV. In children only one study tried to evaluate the association of ondansetron, dexamethasone and droperidol to prevent postoperative vomiting. However, different doses of the different molecules were combined, the extremely complicated design of this study and important methodological bias do not provide evidence about the superiority of the combination of three anti-emetics compared with two anti-emetics. Our present randomized, double-blind study is designed to compare the effectiveness of Droperidol in combination with a conventional bi-prophylaxis (dexamethasone/ondansetron) to the conventional bi-prophylaxis alone to decrease the occurrence of postoperative vomiting in children at high risk. The combination ondansetron and dexamethasone is frequently assessed as an association to prevent postoperative vomiting also in the adult population and in the pediatric population.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-04
• Primary Completion: 2013-07
• Status Verified: 2013-08
• Study Completion: 2014-05
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

• Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
• Between 3 to 18 years
• Informed consent signed or the owner (s) of parental
• Children receiving a social security system

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Exclusion Criteria

• Ambulatory surgery
• Preoperative corticosteroids
• Postoperative sedation
• Allergy known to droperidol, ondansetron or dexamethasone
• Known hypokaliemia
• Known hypomagnesemia
• Bradycardia (<55 bpm)
• Congenital long QT syndrome
• Treatment that induce prolonged QT
• Pheochromocytoma
• Severe depressive syndrome

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone + ondansetron + Droperidol	Dexamethasone + ondansetron + Droperidol	dexamethasone + ondansetron + Droperidol
Dexamethasone + ondansetron + Placebo	Dexamethasone + ondansetron + Placebo	dexamethasone + ondansetron + Placebo

Primary Outcome Measures

Name	Time	Method
Postoperative vomiting	24 hours

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	24 hours	Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France