Asthma Clinical Trial
Official title:
Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
Verified date | October 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | October 2, 2020 |
Est. primary completion date | October 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 7 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Nausea | Presence of nausea after medication administration (yes/no) measured by participant self-report | 1 hour | |
Secondary | 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 | 1 hour |
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