Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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)widely used for paincontrol increase the risk of postoperative bleeding and reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy. Antiemetic and analgesic dose-response has never been established.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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)