Trial Outcomes & Findings for Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup (NCT NCT03705273)
NCT ID: NCT03705273
Last Updated: 2021-11-08
Results Overview
Presence of nausea after medication administration (yes/no) measured by participant self-report
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
1 hour
Results posted on
2021-11-08
Participant Flow
Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets.
Participant milestones
| Measure |
Dexamethasone Tablets
Dexamethasone tablets crushed and administered in apple sauce or pudding at a dose of 0.6 mg/kg
|
Dexamethasone-IV Solution-in-syrup
Dexamethasone-IV solution-in-syrup at a dose of 0.6 mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Baseline characteristics by cohort
| Measure |
Dexamethasone IV for PO
n=20 Participants
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Dexamethasone IV for PO: Common pediatric emergency department practice
|
Dexamethasone Crushed Tablets
n=20 Participants
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Diagnosis asthma
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Diagnosis croup
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
2.75 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
2.70 years
STANDARD_DEVIATION 1.92 • n=7 Participants
|
2.75 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourPresence of nausea after medication administration (yes/no) measured by participant self-report
Outcome measures
| Measure |
Dexamethasone Tablets
n=20 Participants
Dexamethasone tablets crushed and mixed in apple sauce
|
Dexamethasone IV for PO
n=20 Participants
Dexamethasone IV solution mixed with cherry syrup
|
|---|---|---|
|
Number of Participants With Nausea
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 hourReason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose
Outcome measures
| Measure |
Dexamethasone Tablets
n=20 Participants
Dexamethasone tablets crushed and mixed in apple sauce
|
Dexamethasone IV for PO
n=20 Participants
Dexamethasone IV solution mixed with cherry syrup
|
|---|---|---|
|
Number of Participants Requiring Second Dose of Dexamethasone
|
0 Participants
|
0 Participants
|
Adverse Events
Dexamethasone IV for PO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone Crushed Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Donald H. Arnold, MD, MPH
Vanderbilt University School of Medicine
Phone: 16155790516
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place