NCT00403806

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 16, 2010

Status Verified

January 1, 2009

Enrollment Period

2.8 years

First QC Date

November 24, 2006

Last Update Submit

August 13, 2010

Conditions

Postoperative Nausea and VomitingPostoperative Pain

Keywords

AdenotonsillectomyPediatricsPostoperative Nausea and VomitingPainOral intakeDexamethasoneDose finding

Outcome Measures

Primary Outcomes (1)

  • Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy

    24 hours postoperatively

Secondary Outcomes (4)

  • Dose-effect relationship for the prevention of postoperative pain

    24 hours postoperatively

  • Oral intake

    10 days

  • Effect on general outcome

    10 days

  • Investigation of safety (drug-related harm)

    10 days

Study Arms (4)

1

ACTIVE COMPARATOR

Intravenous dexamethasone 0.05 mg per kg bodyweight

Drug: dexamethasone

2

ACTIVE COMPARATOR

Intravenous dexamethasone 0.15 mg per kg bodyweight

Drug: Dexamethasone

3

ACTIVE COMPARATOR

Intravenous dexamethasone 0.5 mg per kg bodyweight

Drug: dexamethasone

4

PLACEBO COMPARATOR

Intravenous saline

Drug: Saline

Interventions

dexamethasoneDRUG

intravenous dexamethasone 0.05 mg per kg bodyweight

Also known as: Mephamesone
1
SalineDRUG

Intravenous saline

Also known as: mephamesone
4

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Elective tonsillectomy with or without adenoidectomy with or without eartubes

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva, Anesthesia Department

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19066382RESULT

MeSH Terms

Conditions

Postoperative Nausea and VomitingPain, PostoperativePain

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingNeurologic Manifestations

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Christoph A Czarnetzki, MD, MBA

    anesthesia department

    PRINCIPAL INVESTIGATOR

  • Martin Tramer, MD, PhD

    anesthesia department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

February 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 16, 2010

Record last verified: 2009-01

Locations

CH(1)