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

Phase 4TerminatedNCT03705273

Vanderbilt University Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma Croup

Interventions

Dexamethasone IV for PODRUG

Common pediatric emergency department practice

Dexamethasone crushed tabletsDRUG

Alternative route of administration for patients unable to swallow tablet whole

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of Participants With Nausea

Presence of nausea after medication administration (yes/no) measured by participant self-report

Time frame: 1 hour

Secondary Outcomes

Number of Participants Requiring Second Dose of Dexamethasone

Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose

Time frame: 1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.