Status:
TERMINATED
Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study
Lead Sponsor:
University Hospital, Geneva
Conditions:
Postoperative Nausea and Vomiting
Postoperative Pain
Eligibility:
All Genders
3-16 years
Phase:
PHASE4
Brief Summary
Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory drugs (NSAIDs...
Detailed Description
1. Primary objective: To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of PONV in children undergoing adeno-tonsillectomy. 2. Secondary objectiv...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Elective tonsillectomy with or without adenoidectomy with or without eartubes
- Exclusion criteria:
- ASA \> II
- Allergie to Dexamethasone
- Recent therapy with steroids or immunotherapy
- Mental retardation
- Children experiencing nausea or vomiting or have taken antiemetic medication within 24 hours before surgery
- Additional surgery
- Enrolement in another investigational study
- Chronic infection or diabetes
- Recent vaccination (less than 1 month prior to surgery)
- Recent varicella infection (less than 1 month prior to surgery)
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00403806
Start Date
February 1 2005
End Date
December 1 2007
Last Update
August 16 2010
Active Locations (1)
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1
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, Switzerland, 1211