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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone and droperidol
Dexamethasone and Ondansetron
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dexamethasone

Dexamethasone and Droperidol

Dexamethasone and Ondansetron

Arm Description

Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.

Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.

Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

Outcomes

Primary Outcome Measures

Incidence of PONV after tonsillectomy with or without adenoidectomy

Secondary Outcome Measures

Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)

Full Information

First Posted
September 13, 2011
Last Updated
February 26, 2014
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT01434017
Brief Title
Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
Official Title
Comparison of Three Different Prophylactic Treatments of PONV in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Arm Title
Dexamethasone and Droperidol
Arm Type
Active Comparator
Arm Description
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Arm Title
Dexamethasone and Ondansetron
Arm Type
Active Comparator
Arm Description
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and droperidol
Intervention Description
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and Ondansetron
Intervention Description
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Primary Outcome Measure Information:
Title
Incidence of PONV after tonsillectomy with or without adenoidectomy
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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

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