Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children

February 26, 2014 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Comparison of Three Different Prophylactic Treatments of PONV in Children

Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

  • dexamethasone alone (250 mcg/kg)
  • dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
  • dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

  • dexamethasone alone (250 mcg/kg)
  • dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
  • dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children aged 2-10 y.
  • children ASA 1-2
  • weight > 15 kg
  • tonsillectomy with or without adenoidectomy

Exclusion Criteria:

  • intravenous induction
  • contraindication to steroids
  • contraindication to antidopaminergic drugs
  • contraindication to serotoninergic antagonists
  • administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery
  • refusal of parents
  • no-french speaking parents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Active Comparator: Dexamethasone and Droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone and droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Active Comparator: Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PONV after tonsillectomy with or without adenoidectomy
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUV-51-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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