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Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis (VPOP2)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01739985
First received: July 20, 2012
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Vomiting
 Drug: Dexamethasone + ondansetron + Placebo
Drug: Dexamethasone + ondansetron + Droperidol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Postoperative vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


Estimated Enrollment: 322
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone + ondansetron + Placebo
dexamethasone + ondansetron + Placebo
 Drug: 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
Experimental: Dexamethasone + ondansetron + Droperidol
dexamethasone + ondansetron + Droperidol
 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

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

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739985

Contacts
Contact: Nathalie BOURDAUD, MD, PhD nathalie.bourdau@nck.aphp.fr
Contact: Laurence LECOMTE, MD, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Necker Hospital Recruiting
Paris, France, 75015
Contact: Nathalie BOURDAUD, MD, PhD         nathalie.bourdau@nck.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Gilles ORLIAGUET, MD, PhD Necker Hospital
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01739985     History of Changes
Other Study ID Numbers: P081228, 2009-017293-20
Study First Received: July 20, 2012
Last Updated: November 29, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postoperative
Vomiting
Children
Prophylaxis
 Droperidol
Ondansetron
Dexamethasone

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Dexamethasone acetate
Dexamethasone
Droperidol
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013