Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Study Details
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dexamethasone IV for PO Dexamethasone IV for PO solution mixed with sugar syrup to be given orally |
Drug: Dexamethasone IV for PO
Common pediatric emergency department practice
Other Names:
|
Active Comparator: Dexamethasone crushed tablets Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally |
Drug: Dexamethasone crushed tablets
Alternative route of administration for patients unable to swallow tablet whole
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Nausea [1 hour]
Presence of nausea after medication administration (yes/no) measured by participant self-report
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Donald Arnold, MD, MPH, Vanderbilt University Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 181682
Study Results
Participant Flow
Recruitment Details | Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Dexamethasone Tablets | Dexamethasone-IV Solution-in-syrup |
---|---|---|
Arm/Group Description | Dexamethasone tablets crushed and administered in apple sauce or pudding at a dose of 0.6 mg/kg | Dexamethasone-IV solution-in-syrup at a dose of 0.6 mg/kg |
Period Title: Overall Study | ||
STARTED | 20 | 20 |
COMPLETED | 20 | 20 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
---|---|---|---|
Arm/Group Description | Dexamethasone IV for PO solution mixed with sugar syrup to be given orally Dexamethasone IV for PO: Common pediatric emergency department practice | Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup | Total of all reporting groups |
Overall Participants | 20 | 20 | 40 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
2.75
(1.88)
|
2.70
(1.92)
|
2.75
(1.88)
|
Sex: Female, Male (Count of Participants) | |||
Female |
7
35%
|
12
60%
|
19
47.5%
|
Male |
13
65%
|
8
40%
|
21
52.5%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
15
75%
|
15
75%
|
30
75%
|
White |
5
25%
|
5
25%
|
10
25%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
20
100%
|
20
100%
|
40
100%
|
Diagnosis asthma (Count of Participants) | |||
Count of Participants [Participants] |
15
75%
|
16
80%
|
31
77.5%
|
Diagnosis croup (Count of Participants) | |||
Count of Participants [Participants] |
5
25%
|
4
20%
|
9
22.5%
|
Outcome Measures
Title | Number of Participants With Nausea |
---|---|
Description | Presence of nausea after medication administration (yes/no) measured by participant self-report |
Time Frame | 1 hour |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Dexamethasone Tablets | Dexamethasone IV for PO |
---|---|---|
Arm/Group Description | Dexamethasone tablets crushed and mixed in apple sauce | Dexamethasone IV solution mixed with cherry syrup |
Measure Participants | 20 | 20 |
Count of Participants [Participants] |
3
15%
|
0
0%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Dexamethasone Tablets | Dexamethasone IV for PO |
---|---|---|
Arm/Group Description | Dexamethasone tablets crushed and mixed in apple sauce | Dexamethasone IV solution mixed with cherry syrup |
Measure Participants | 20 | 20 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
Time Frame | Time of randomization up to one hour after last dose of treatment | |||
---|---|---|---|---|
Adverse Event Reporting Description | Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | |||
Arm/Group Title | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | ||
Arm/Group Description | Dexamethasone IV for PO solution mixed with sugar syrup to be given orally Dexamethasone IV for PO: Common pediatric emergency department practice | Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally Dexamethasone crushed tablets: Alternative route of administration for patients unable to swallow tablet whole | ||
All Cause Mortality |
||||
Dexamethasone IV for PO | Dexamethasone Crushed Tablets | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | 0/20 (0%) | ||
Serious Adverse Events |
||||
Dexamethasone IV for PO | Dexamethasone Crushed Tablets | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Dexamethasone IV for PO | Dexamethasone Crushed Tablets | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/20 (0%) | 0/20 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Donald H. Arnold, MD, MPH |
---|---|
Organization | Vanderbilt University School of Medicine |
Phone | 16155790516 |
don.arnold@vumc.org |
- 181682