drugset / Trial / NCT01739985
Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
Completed
322 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2013-07
- Completion
- 2014-05
Outcome
Missed primary endpoint
paper The overall incidence of POV did not differ significantly between the two groups PMID 28505233 ↗
paper 16 patients in Group A (10.5%) and 18 in Group B (11.1%) presenting with one or more episodes of POV, P =0.86. PMID 28505233 ↗
Publications
- Background 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.
- Background 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Droperidol | Small molecule | 50 ug/kg | — |
| Background | Dexamethasone | Small molecule | 125 ug/kg | — |
| Background | Ondansetron | Other / unclassified | 100 ug/kg | — |
Indications
No indication recorded.