Back to resultsComparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Primary Purpose
Asthma, Croup
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone IV for PO
Dexamethasone crushed tablets
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexamethasone IV for PO
Dexamethasone crushed tablets
Arm Description
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally
Outcomes
Primary Outcome Measures
Number of Participants With Nausea
Presence of nausea after medication administration (yes/no) measured by participant self-report
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03705273
First Posted
October 9, 2018
Last Updated
October 11, 2021
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03705273
Brief Title
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Official Title
Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Croup
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone IV for PO
Arm Type
Experimental
Arm Description
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Arm Title
Dexamethasone crushed tablets
Arm Type
Active Comparator
Arm Description
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally
Intervention Type
Drug
Intervention Name(s)
Dexamethasone IV for PO
Other Intervention Name(s)
Dexamethasone injection
Intervention Description
Common pediatric emergency department practice
Intervention Type
Drug
Intervention Name(s)
Dexamethasone crushed tablets
Other Intervention Name(s)
Dexamethasone oral tablet
Intervention Description
Alternative route of administration for patients unable to swallow tablet whole
Primary Outcome Measure Information:
Title
Number of Participants With Nausea
Description
Presence of nausea after medication administration (yes/no) measured by participant self-report
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Second Dose of Dexamethasone
Description
Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Arnold, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
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