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

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ClinicalTrials.gov Identifier: NCT01739985
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Postoperative Vomiting Drug: Dexamethasone + ondansetron + Placebo Drug: Dexamethasone + ondansetron + Droperidol

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis
Study Start Date : December 2010
Primary Completion Date : July 2013
Study Completion Date : May 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Postoperative vomiting [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 24 hours ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739985

Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Study Chair: Gilles ORLIAGUET, MD, PhD Necker Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01739985     History of Changes
Other Study ID Numbers: P081228
2009-017293-20 ( EudraCT Number )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: August 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents