Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
Information source: Centre Hospitalier Universitaire Vaudois
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: Dexamethasone (Drug); Dexamethasone and droperidol (Drug); Dexamethasone and Ondansetron (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Centre Hospitalier Universitaire Vaudois Official(s) and/or principal investigator(s):
Eric Albrecht, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois
Overall contact:
Eric Albrecht, MD, Phone: +16479299367, Email: Eric.Albrecht@chuv.ch
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).
Clinical Details
Official title: Comparison of Three Different Prophylactic Treatments of PONV in Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of PONV after tonsillectomy with or without adenoidectomy
Secondary outcome: Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 10 Years.
Gender(s): Both.
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
Locations and Contacts
Eric Albrecht, MD, Phone: +16479299367, Email: Eric.Albrecht@chuv.ch
Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Vaud 1011, Switzerland; Recruiting
Eric Albrecht, MD, Phone: +16479299367, Email: Eric.Albrecht@chuv.ch
PIerre Flubacher, MD, Phone: +41213141111, Email: Pierre.Flubacher@chuv.ch
Additional Information
Starting date: November 2008
Last updated: September 13, 2011
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