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

Phase 4 Terminated 215 enrolled University Hospital, Geneva

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2005-02
Primary completion: 2007-12
Completion: 2007-12

Outcome

Outcome not reported

Stopped: “drug-related harm”

Publications

Results Czarnetzki C, Elia N, Lysakowski C, Dumont L, Landis BN, Giger R, Dulguerov P, Desmeules J, Tramer MR. Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial. JAMA. 2008 Dec 10;300(22):2621-30. doi: 10.1001/jama.2008.794.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexamethasone	Small molecule	0.05 mg/kg	Intravenous
Comparator	Dexamethasone	Small molecule	0.15 mg/kg	Intravenous
Comparator	Dexamethasone	Small molecule	0.5 mg/kg	Intravenous

Indications

No indication recorded.