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

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Asthma; Croup

Treatments: Drug: Dexamethasone IV for PO; Drug: Dexamethasone crushed tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03705273

181682

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Dexamethasone IV for PO

Experimental group

Description:

Dexamethasone IV for PO solution mixed with sugar syrup to be given orally

Treatment:

Drug: Dexamethasone IV for PO

Dexamethasone crushed tablets

Active Comparator group

Description:

Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally

Treatment:

Drug: Dexamethasone crushed tablets