VPOP2: Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexamethasone + ondansetron + Placebo dexamethasone + ondansetron + Placebo |
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
|
| Experimental: Dexamethasone + ondansetron + Droperidol dexamethasone + ondansetron + Droperidol |
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
|
Outcome Measures
Primary Outcome Measures
- Postoperative vomiting [24 hours]
Secondary Outcome Measures
- Safety and Tolerability [24 hours]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
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Between 3 to 18 years
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Informed consent signed or the owner (s) of parental
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Children receiving a social security system
Exclusion Criteria:
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Ambulatory surgery
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Preoperative corticosteroids
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Postoperative sedation
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Allergy known to droperidol, ondansetron or dexamethasone
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Known hypokaliemia
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Known hypomagnesemia
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Bradycardia (<55 bpm)
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Congenital long QT syndrome
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Treatment that induce prolonged QT
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Pheochromocytoma
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Severe depressive syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Necker Hospital | Paris | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Study Chair: Gilles ORLIAGUET, MD, PhD, Necker Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51.
- Gunter JB, McAuliffe JJ, Beckman EC, Wittkugel EP, Spaeth JP, Varughese AM. A factorial study of ondansetron, metoclopramide, and dexamethasone for emesis prophylaxis after adenotonsillectomy in children. Paediatr Anaesth. 2006 Nov;16(11):1153-65.
- P081228
- 2009-017293-20