DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Assistance Publique - H˘pitaux de Paris
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Vomiting

Intervention: Dexamethasone + ondansetron + Placebo (Drug); Dexamethasone + ondansetron + Droperidol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Gilles ORLIAGUET, MD, PhD, Study Chair, Affiliation: Necker Hospital

Overall contact:
Nathalie BOURDAUD, MD, PhD, Email: nathalie.bourdau@nck.aphp.fr

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Postoperative vomiting

Secondary outcome: Safety and Tolerability

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.

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Nathalie BOURDAUD, MD, PhD, Email: nathalie.bourdau@nck.aphp.fr

Necker Hospital, Paris 75015, France; Recruiting
Nathalie BOURDAUD, MD, PhD, Email: nathalie.bourdau@nck.aphp.fr
Additional Information

Related publications:

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.

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.

Starting date: December 2010
Last updated: November 29, 2012

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012