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Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

This study has been completed.
Sponsor:
Collaborator:
IWK Foundation
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00973687
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 8, 2009
September 8, 2009
September 2004
April 2006   (final data collection date for primary outcome measure)
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma. [ Time Frame: During Emergency Department visit ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation. [ Time Frame: 7-14 days following emergency dept visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Ora Sweet
    A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.
  • Drug: Dexamethasone
  • No Intervention: 10 mg/mL Unsweetened Formulation
    no prior vomiting
    Intervention: Drug: Dexamethasone
  • Experimental: 1 mg/mL Ora Sweet Formulation
    no prior vomiting
    Interventions:
    • Drug: Ora Sweet
    • Drug: Dexamethasone
  • No Intervention: 10 mg/mL Unsweetened with prior vomiting
    with prior vomiting
    Intervention: Drug: Dexamethasone
  • Experimental: 1 mg/mL Ora Sweet with prior vomiting
    with prior vomiting
    Interventions:
    • Drug: Ora Sweet
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
May 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute asthma exacerbation
  • requiring oral systemic corticosteroids for management

Exclusion Criteria:

  • preference for pills over liquid formulation
  • history of Nissen fundoplication surgery
  • needed immediate airway intervention
  • require oral medications to be given via a G or J tube
  • if patient care would be compromised
  • enrolled in the study on a previous visit.
Both
2 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00973687
2967
No
Dr. Lyn Sonnenberg, IWK Health Centre
IWK Health Centre
IWK Foundation
Principal Investigator: Lyn K Sonnenberg, MD IWK Health Centre
IWK Health Centre
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP