Asthma, Croup
Conditions
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.
Interventions
DRUGDexamethasone IV for PO
Common pediatric emergency department practice
DRUGDexamethasone crushed tablets
Alternative route of administration for patients unable to swallow tablet whole
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nausea | 1 hour | Presence of nausea after medication administration (yes/no) measured by participant self-report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone IV for PO Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Dexamethasone IV for PO: Common pediatric emergency department practice | 20 |
| Dexamethasone Crushed Tablets Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Dexamethasone Crushed Tablets | Total | Dexamethasone IV for PO |
|---|---|---|---|
| Age, Continuous | 2.70 years STANDARD_DEVIATION 1.92 | 2.75 years STANDARD_DEVIATION 1.88 | 2.75 years STANDARD_DEVIATION 1.88 |
| Diagnosis asthma | 16 Participants | 31 Participants | 15 Participants |
| Diagnosis croup | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 12 Participants | 19 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 21 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Number of Participants With Nausea
Presence of nausea after medication administration (yes/no) measured by participant self-report
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Tablets | Number of Participants With Nausea | 3 Participants |
| Dexamethasone IV for PO | Number of Participants With Nausea | 0 Participants |
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Tablets | Number of Participants Requiring Second Dose of Dexamethasone | 0 Participants |
| Dexamethasone IV for PO | Number of Participants Requiring Second Dose of Dexamethasone | 0 Participants |