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Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone IV for PO | Experimental | Dexamethasone IV for PO solution mixed with sugar syrup to be given orally |
|
| Dexamethasone crushed tablets | Active Comparator | Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone IV for PO | Drug | Common pediatric emergency department practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nausea | Presence of nausea after medication administration (yes/no) measured by participant self-report | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Arnold, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36596609 | Derived | Goettel AM, Hanson HR, Overfield J, Thornton C, Arnold DH. Tastes great, less filling! Randomized trial comparing perceived palatability of dexamethasone preparations in children. Ann Allergy Asthma Immunol. 2023 Jan;130(1):114-115. doi: 10.1016/j.anai.2022.09.016. No abstract available. |
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Forty participants were enrolled and randomized, of which 20 were randomized to receive dexamethasone tablets.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Tablets | Dexamethasone tablets crushed and administered in apple sauce or pudding at a dose of 0.6 mg/kg |
| FG001 | Dexamethasone-IV Solution-in-syrup | Dexamethasone-IV solution-in-syrup at a dose of 0.6 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Dexamethasone Crushed Tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Nausea | Presence of nausea after medication administration (yes/no) measured by participant self-report | Posted | Count of Participants | Participants | 1 hour |
|
|
Time of randomization up to one hour after last dose of treatment
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald H. Arnold, MD, MPH | Vanderbilt University School of Medicine | 16155790516 | don.arnold@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2018 | Sep 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003440 | Croup |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexamethasone crushed tablets | Drug | Alternative route of administration for patients unable to swallow tablet whole |
|
|
Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally or dexamethasone IV solution in cherry syrup
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis asthma | Count of Participants | Participants |
|
| Diagnosis croup | Count of Participants | Participants |
|
| 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 | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Dexamethasone Crushed Tablets | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007827 | Laryngitis |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |