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

Phase 4

Terminated

• Conditions: Croup; Asthma
• Interventions: Drug: Dexamethasone IV for PO; Drug: Dexamethasone crushed tablets

• Registration Number: NCT03705273
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-10-23
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-02
• Results First Submitted: 2021-09-13
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Results First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Allergy to dexamethasone or apple sauce and pudding
• Unable to take medication orally

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone IV for PO	Dexamethasone IV for PO	Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Dexamethasone crushed tablets	Dexamethasone crushed tablets	Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally

Primary Outcome Measures

Name	Time	Method
Number of Participants With Nausea	1 hour	Presence of nausea after medication administration (yes/no) measured by participant self-report

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Second Dose of Dexamethasone	1 hour	Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States