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

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

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Source 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.

Overall Status Completed
Start Date December 2010
Completion Date May 2014
Primary Completion Date July 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative vomiting 24 hours
Secondary Outcome
Measure Time Frame
Safety and Tolerability 24 hours
Enrollment 322
Condition
Intervention

Intervention type: Drug

Intervention name: Dexamethasone + ondansetron + Placebo

Description: 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

Arm group label: Dexamethasone + ondansetron + Placebo

Intervention type: Drug

Intervention name: Dexamethasone + ondansetron + Droperidol

Description: 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

Arm group label: Dexamethasone + ondansetron + Droperidol

Eligibility

Criteria:

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

Gender: All

Minimum age: 3 Years

Maximum age: 17 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gilles ORLIAGUET, MD, PhD Study Chair Necker Hospital
Location
facility
Necker Hospital
Location Countries

France

Verification Date

August 2013

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Dexamethasone + ondansetron + Placebo

Arm group type: Active Comparator

Description: dexamethasone + ondansetron + Placebo

Arm group label: Dexamethasone + ondansetron + Droperidol

Arm group type: Experimental

Description: dexamethasone + ondansetron + Droperidol

Acronym VPOP2
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov