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

NCT ID: NCT03705273

Last Updated: 2021-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2020-10-02

Brief Summary

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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

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Conditions

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Asthma Croup

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone IV for PO

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

Group Type EXPERIMENTAL

Dexamethasone IV for PO

Intervention Type DRUG

Common pediatric emergency department practice

Dexamethasone crushed tablets

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

Group Type ACTIVE_COMPARATOR

Dexamethasone crushed tablets

Intervention Type DRUG

Alternative route of administration for patients unable to swallow tablet whole

Interventions

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Dexamethasone IV for PO

Common pediatric emergency department practice

Intervention Type DRUG

Dexamethasone crushed tablets

Alternative route of administration for patients unable to swallow tablet whole

Intervention Type DRUG

Other Intervention Names

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Dexamethasone injection Dexamethasone oral tablet

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Donald H Arnold

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald Arnold, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Goettel AM, Hanson HR, Overfield J, Thornton C, Arnold DH. Tastes great, less filling! Randomized trial comparing perceived palatability of dexamethasone preparations in children. Ann Allergy Asthma Immunol. 2023 Jan;130(1):114-115. doi: 10.1016/j.anai.2022.09.016. No abstract available.

Reference Type DERIVED
PMID: 36596609 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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181682

Identifier Type: -

Identifier Source: org_study_id