Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
Condition: Postoperative Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

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.
    

Intervention name(s): Dexamethasone + ondansetron + Placebo; Dexamethasone + ondansetron + Droperidol
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Droperidol; Ondansetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Postoperative; Vomiting; Children; Prophylaxis; Droperidol; Ondansetron; Dexamethasone