Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study - Full Text View

Sponsor:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00403806

Purpose

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.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting Postoperative Pain	Drug: dexamethasone Drug: Dexamethasone Drug: Saline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised, Placebo-controlled, Double-blind, Dose-finding Study

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Tonsils and Adenoids

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose-effect relationship for the prevention of postoperative pain [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
Oral intake [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Effect on general outcome [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Investigation of safety (drug-related harm) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment:	215
Study Start Date:	February 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Intravenous dexamethasone 0.05 mg per kg bodyweight	Drug: dexamethasone intravenous dexamethasone 0.05 mg per kg bodyweight Other Name: Mephamesone
Active Comparator: 2 Intravenous dexamethasone 0.15 mg per kg bodyweight	Drug: Dexamethasone Intravenous dexamethasone 0.15 mg per kg bodyweight Other Name: mephamesone
Active Comparator: 3 Intravenous dexamethasone 0.5 mg per kg bodyweight	Drug: dexamethasone Intravenous dexamethasone 0.5 mg per kg bodyweight Other Name: mephamesone
Placebo Comparator: 4 Intravenous saline	Drug: Saline Intravenous saline Other Name: mephamesone

Show Detailed Description

Eligibility

Ages Eligible for Study:	3 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403806

Locations

Switzerland
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:	Christoph A Czarnetzki, MD, MBA	Anesthesia Department
Study Chair:	Martin Tramer, MD, PhD	Anesthesia Department

More Information

Publications:

Czarnetzki C, Elia N, Lysakowski C, Dumont L, Landis BN, Giger R, Dulguerov P, Desmeules J, Tramèr 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.

Responsible Party:	Christoph Czarnetzki MD, University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00403806 History of Changes
Other Study ID Numbers:	NAC 04-005, Swissmedic DR 3028
Study First Received:	November 24, 2006
Last Updated:	August 13, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Adenotonsillectomy
Pediatrics
Postoperative Nausea and Vomiting
Pain

Oral intake
Dexamethasone
Dose finding

Additional relevant MeSH terms:

Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012