Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
VPOP2
2 other identifiers
interventional
322
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 13, 2026
February 1, 2026
2.6 years
July 20, 2012
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative vomiting
24 hours
Secondary Outcomes (1)
Safety and Tolerability
24 hours
Study Arms (2)
Dexamethasone + ondansetron + Placebo
ACTIVE COMPARATORdexamethasone + ondansetron + Placebo
Dexamethasone + ondansetron + Droperidol
EXPERIMENTALdexamethasone + ondansetron + Droperidol
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necker Hospital
Paris, 75015, France
Related Publications (3)
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.
PMID: 17040305BACKGROUNDApfel 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.
PMID: 15190136BACKGROUNDBourdaud 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.
PMID: 28505233RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gilles ORLIAGUET, MD, PhD
Necker Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
December 4, 2012
Study Start
December 1, 2010
Primary Completion
July 1, 2013
Study Completion
May 1, 2014
Last Updated
February 13, 2026
Record last verified: 2026-02