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

This study has been terminated.
(drug-related harm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403806
First Posted: November 27, 2006
Last Update Posted: August 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Dose-effect relationship for the prevention of postoperative pain [ Time Frame: 24 hours postoperatively ]
  • Oral intake [ Time Frame: 10 days ]
  • Effect on general outcome [ Time Frame: 10 days ]
  • Investigation of safety (drug-related harm) [ Time Frame: 10 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: November 24, 2006
First Posted: November 27, 2006
Last Update Posted: August 16, 2010
Last Verified: January 2009

Keywords provided by University Hospital, Geneva:
Adenotonsillectomy
Pediatrics
Postoperative Nausea and Vomiting
Pain
Oral intake
Dexamethasone
Dose finding

Additional relevant MeSH terms:
Pain, Postoperative
Nausea
Vomiting
Postoperative Nausea and Vomiting
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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