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

This study has been terminated.
(drug-related harm)
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00403806
First received: November 24, 2006
Last updated: August 13, 2010
Last verified: January 2009
  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
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Pain, Postoperative
Vomiting
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 August 28, 2014