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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03705273
• Other study ID #: 181682
• Status: Terminated
• Phase: Phase 4
• Start date: October 23, 2018
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Asthma
• Croup

Intervention

Drug:
• Dexamethasone IV for PO
Common pediatric emergency department practice
• Dexamethasone crushed tablets
Alternative route of administration for patients unable to swallow tablet whole

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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