Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Purpose

Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.

Conditions

  • Asthma
  • Croup

Eligibility

Eligible Ages
Between 1 Year and 7 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department - Age 1 to 7 years - Dexamethasone treatment indicated - No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis) - Have not received systemic corticosteroid for current episode prior to enrollment

Exclusion Criteria

  • Allergy to dexamethasone or apple sauce and pudding - Unable to take medication orally

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dexamethasone IV for PO
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
  • Drug: Dexamethasone IV for PO
    Common pediatric emergency department practice
    Other names:
    • Dexamethasone injection
Active Comparator
Dexamethasone crushed tablets
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally
  • Drug: Dexamethasone crushed tablets
    Alternative route of administration for patients unable to swallow tablet whole
    Other names:
    • Dexamethasone oral tablet

More Details

Status
Terminated
Sponsor
Vanderbilt University Medical Center

Study Contact