Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Vomiting
Intervention: Dexamethasone + ondansetron + Placebo (Drug); Dexamethasone + ondansetron + Droperidol (Drug)
Sponsored by: Assistance Publique - H˘pitaux de Paris
Official(s) and/or principal investigator(s):
Gilles ORLIAGUET, MD, PhD, Study Chair, Affiliation: Necker Hospital
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.
Official title: Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Postoperative vomiting
Secondary outcome: Safety and Tolerability
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.
Minimum age: 3 Years.
Maximum age: 17 Years.
- 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
- 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
- Severe depressive syndrome
Locations and Contacts
Necker Hospital, Paris 75015, France
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.
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.
Starting date: December 2010
Last updated: July 25, 2014