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

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.

Full Title of Study: “Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2019

Interventions

  • Drug: Dexamethasone IV for PO
    • Common pediatric emergency department practice
  • Drug: Dexamethasone crushed tablets
    • Alternative route of administration for patients unable to swallow tablet whole

Arms, Groups and Cohorts

  • Experimental: Dexamethasone IV for PO
    • Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
  • Active Comparator: Dexamethasone crushed tablets
    • Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally

Clinical Trial Outcome Measures

Primary Measures

  • Taste
    • Time Frame: 1 hour
    • Child’s reaction to taste of dexamethasone on 5-point smiley-face analog scale that measures taste. Total score will be a number from 1 to 5 (1 = strongly dislike, 5 = strongly like). A higher number is considered to be a better outcome.

Secondary Measures

  • Patients with nausea
    • Time Frame: 1 hour
    • Perceived nausea in the child after receiving dexamethasone; parents will be asked “did your child look like he/she wanted to throw up?”
  • Reason for requiring a second dose of dexamethasone
    • Time Frame: 1 hour
    • Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Donald H Arnold, Professor of Pediatrics – Vanderbilt University Medical Center
  • Overall Official(s)
    • Donald Arnold, MD, MPH, Principal Investigator, Vanderbilt University Medical Center
  • Overall Contact(s)
    • Andrea Goettel, PharmD, (615) 936-5495, Andrea.Goettel@vumc.org

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