Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
1 other identifier
interventional
300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 27, 2014
February 1, 2014
4.6 years
September 13, 2011
February 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of PONV after tonsillectomy with or without adenoidectomy
48 hours
Secondary Outcomes (1)
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
48 hours
Study Arms (3)
Dexamethasone
ACTIVE COMPARATORPatients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone and Droperidol
ACTIVE COMPARATORPatients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and Ondansetron
ACTIVE COMPARATORPatients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Interventions
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.
Eligibility Criteria
You may qualify if:
- children aged 2-10 y.
- children ASA 1-2
- weight \> 15 kg
- tonsillectomy with or without adenoidectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Albrecht
Centre Hospitalier Universitaire Vaudois
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
November 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 27, 2014
Record last verified: 2014-02