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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis

Conditions
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Postoperative Vomiting

Intervention / Treatment
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* Drug: Dexamethasone + ondansetron + Placebo
* Drug: Dexamethasone + ondansetron + Droperidol


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone + ondansetron + Placebo<br>dexamethasone + ondansetron + Placebo | Drug: Dexamethasone + ondansetron + Placebo<br>* 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<br>|
| Experimental: Dexamethasone + ondansetron + Droperidol<br>dexamethasone + ondansetron + Droperidol | Drug: Dexamethasone + ondansetron + Droperidol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative vomiting |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vomiting, Children, Prophylaxis, Droperidol, Ondansetron, Dexamethasone, Postoperative