Vanderbilt Clinical Trials

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.