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

October 11, 2021 updated by: Donald H Arnold, Vanderbilt University Medical Center

Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup

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 Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone IV for PO
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
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
Alternative route of administration for patients unable to swallow tablet whole
Other Names:
  • Dexamethasone oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Nausea
Time Frame: 1 hour
Presence of nausea after medication administration (yes/no) measured by participant self-report
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring 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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donald Arnold, MD, MPH, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2018

Primary Completion (ACTUAL)

October 2, 2020

Study Completion (ACTUAL)

October 2, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (ACTUAL)

October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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