A Phase 4 interventional study of Dexamethasone IV for PO and Dexamethasone crushed tablets in Asthma and Croup, sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Dexamethasone IV for PO solution mixed with sugar syrup to be given orally
Drug: Dexamethasone IV for PO
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally
Drug: Dexamethasone crushed tablets
Common pediatric emergency department practice
Also known as: Dexamethasone injection
Alternative route of administration for patients unable to swallow tablet whole
Also known as: Dexamethasone oral tablet
Number of Participants With Nausea
Presence of nausea after medication administration (yes/no) measured by participant self-report
Time frame: 1 hour
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
Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets.
| Milestone | Dexamethasone Tablets | Dexamethasone-IV Solution-in-syrup |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Presence of nausea after medication administration (yes/no) measured by participant self-report
| Participants | Dexamethasone Tablets | Dexamethasone IV for PO |
|---|---|---|
| Number of Participants With Nausea | 3 | 0 |
Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose
| Participants | Dexamethasone Tablets | Dexamethasone IV for PO |
|---|---|---|
| Number of Participants Requiring Second Dose of Dexamethasone | 0 | 0 |
Collected over Time of randomization up to one hour after last dose of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone IV for PO | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Dexamethasone Crushed Tablets | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| Mean | 2.75 ± 1.88 | 2.70 ± 1.92 | 2.75 ± 1.88 |
| Sex: Female, Male(Participants) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| Female | 7 | 12 | 19 |
| Male | 13 | 8 | 21 |
| Race (NIH/OMB)(Participants) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 15 | 30 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Diagnosis asthma(Participants) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| Count of participants | 15 | 16 | 31 |
| Diagnosis croup(Participants) | Dexamethasone IV for PO | Dexamethasone Crushed Tablets | Total |
|---|---|---|---|
| Count of participants | 5 | 4 | 9 |
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Vanderbilt University Medical Center