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

NCT ID: NCT01739985

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-05-31

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.

Conditions

Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone + ondansetron + Placebo

dexamethasone + ondansetron + Placebo

Group Type: ACTIVE_COMPARATOR

Dexamethasone + ondansetron + Placebo

Intervention Type: DRUG

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

Dexamethasone + ondansetron + Droperidol

dexamethasone + ondansetron + Droperidol

Group Type: EXPERIMENTAL

Dexamethasone + ondansetron + Droperidol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles ORLIAGUET, MD, PhD

Role: STUDY_CHAIR

Necker Hospital

Locations

Necker Hospital

Paris, , France

Countries

France

References

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. doi: 10.1111/j.1460-9592.2006.01952.x.

Reference Type: BACKGROUND

PMID: 17040305 (View on PubMed)

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. doi: 10.1056/NEJMoa032196.

Reference Type: BACKGROUND

PMID: 15190136 (View on PubMed)

Bourdaud N, Francois C, Jacqmarcq O, Guye ML, Jean J, Studer C, Engrand-Donal C, Devys JM, Boutin F, Guyot E, Bouazza N, Treluyer JM, Orliaguet GA; VPOP2 group. Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative vomiting. A randomized, controlled, double-blind study. Br J Anaesth. 2017 Jun 1;118(6):918-923. doi: 10.1093/bja/aex099.

Reference Type: RESULT

PMID: 28505233 (View on PubMed)

Other Identifiers

2009-017293-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P081228

Identifier Type: -

Identifier Source: org_study_id