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The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs. two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.
The emergency department (ED) physician will follow the standard asthma care path to manage a pediatric asthma patient whether the patient meets study criteria or not. Patients' legal guardian will be approached for consent if patient meets the study criteria. Once the consent is obtained, the patient will be randomized into one of the two study groups according to a randomization table generated by a statistician. The first group will receive a single dose of dexamethasone sodium phosphate injection (0.6 mg/kg with max of 16 mg) mixed with equivalent volume of cherry syrup given orally in the ED. The second group will receive a first dose of dexamethasone with cherry syrup (also 0.6 mg/kg with max of 16 mg) in the ED, and a second dose will be prescribed to the patient at home on the day following the ED visit. This dose will be the same dosage of dexamethasone, but may be a pill or liquid form. Patients will continue their previously prescribed asthma regimen and albuterol as needed. Children who vomit the steroids in the ED will be re-dosed. Children who vomit the steroid a second time will be excluded from the study.
2. Data collection. Demographic information such as age, race, duration of asthma symptoms, number of previous hospitalizations, and current medication will be collected on an ED data collection form. Pertinent exam findings such as patient's vital signs, pulse oximetry, Pediatric asthma severity score (PAS), patient asthma severity self-assessment sheets (PSAS), and ED treatment will also be collected on an ED data collection form.
After discharge from the ED, patients will be instructed to complete the PSAS on a daily basis for 5 days. The data will be documented on a home patient self-assessment sheet by the legal guardian. The investigators will train the legal guardians on how to complete the PSAS in the ED.
3. Phone follow-up All patients will be contacted by phone by a research assistant 5 days after the ED visit. Information collected during the phone interview will include PSAS, unexpected visits to medical providers (ED, primary care or urgent care) for asthma symptoms, school days missed due to asthma exacerbation, length of time symptoms persisted, compliance with the recommended steroid regimen, vomiting, other side effects or medication administration problems caused by the steroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Dexamethasone | Experimental | 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once |
|
| Two Dose Dexamethasone | Experimental | 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Returning to Care Following Discharge From the Emergency Department | The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Number of Days Until Symptom Resolution | Will determine number of days to symptom resolution, including missed school days. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Side Effects Experienced by Participants | The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache. | 5 days |
Inclusion Criteria:
History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing which responded to beta agonist medication.
Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan E Martin, MD | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Children's Hospital Of Buffalo | Buffalo | New York | 14222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26712860 | Background | Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28. | |
| 17983880 | Background | National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. |
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Excluded 10 Patients:
Previously enrolled into the study: 2 Admitted to the PICU (pediatric intensive care unit): 5 Required IV steroids in the Emergency Dept: 1 Steroid use within the last 2 weeks: 1 Excessive vomiting in the Emergency Dept: 1
Patients presenting with asthma symptoms to a single pediatric emergency department
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Dose Dexamethasone | 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once Dexamethasone Sodium Phosphate Injection |
| FG001 | Two Dose Dexamethasone | 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form. Dexamethasone Sodium Phosphate Injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Dose Dexamethasone | 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once Dexamethasone Sodium Phosphate Injection |
| BG001 | Two Dose Dexamethasone |
| 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 Returning to Care Following Discharge From the Emergency Department | The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician. | Posted | Count of Participants | Participants | 5 days |
|
5 days
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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 | Single Dose Dexamethasone | This group was the standard arm and received one single dose of dexamethasone in the Emergency department |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment | Reported decrease in appetite |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Martin | Johns Hopkins all childrens hospital | 9417373107 | mmart163@jhmi.edu |
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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 | Nov 9, 2017 | Nov 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2017 | Sep 23, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
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| 1997850 | Background | Chapman KR, Verbeek PR, White JG, Rebuck AS. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. N Engl J Med. 1991 Mar 21;324(12):788-94. doi: 10.1056/NEJM199103213241202. |
| 12897291 | Background | Rachelefsky G. Treating exacerbations of asthma in children: the role of systemic corticosteroids. Pediatrics. 2003 Aug;112(2):382-97. doi: 10.1542/peds.112.2.382. |
| 8414819 | Background | Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8. |
| 9713398 | Background | Zoorob RJ, Cender D. A different look at corticosteroids. Am Fam Physician. 1998 Aug;58(2):443-50. |
| 22909281 | Background | Cronin J, Kennedy U, McCoy S, An Fhaili SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141. |
| 19801100 | Background | Karaman M, Ilhan AE, Dereci G, Tek A. Determination of optimum dosage of intraoperative single dose dexamethasone in pediatric tonsillectomy and adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1513-5. doi: 10.1016/j.ijporl.2009.06.001. Epub 2009 Jul 10. |
| 11445789 | Background | Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021. |
| 18467673 | Background | Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8. |
| 24515516 | Background | Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10. |
| 10831004 | Background | Kelly CS, Andersen CL, Pestian JP, Wenger AD, Finch AB, Strope GL, Luckstead EF. Improved outcomes for hospitalized asthmatic children using a clinical pathway. Ann Allergy Asthma Immunol. 2000 May;84(5):509-16. doi: 10.1016/S1081-1206(10)62514-8. |
| 18803532 | Background | Chang AB, Clark R, Sloots TP, Stone DG, Petsky HL, Thearle D, Champion AA, Wheeler C, Acworth JP. A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised: a randomised controlled trial. Med J Aust. 2008 Sep 15;189(6):306-10. doi: 10.5694/j.1326-5377.2008.tb02046.x. |
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Dexamethasone Sodium Phosphate Injection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Tobacco exposure in home | Count of Participants | Participants |
|
| Number of days with symptoms | Mean | Standard Deviation | days |
|
| Current use of asthma controller medication | Count of Participants | Participants |
|
| Number of previous hospital admissions | Mean | Standard Deviation | admissions |
|
| Pediatric Asthma Score before albuterol administered | Pediatric asthma Scores (based on respiratory rate by age, oxygen requirements, auscultation, retractions, dyspnea): 5-7 Mild exacerbation 8-11 Moderate exacerbation 12-15 Severe exacerbation | PAS scores not available for all participants | Mean | Standard Deviation | PAS score |
|
|
|
| Secondary | Reported Number of Days Until Symptom Resolution | Will determine number of days to symptom resolution, including missed school days. | Posted | Mean | Standard Deviation | Days | 5 days |
|
|
|
| Other Pre-specified | Reported Side Effects Experienced by Participants | The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache. | Posted | Count of Participants | Participants | 5 days |
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| 20 |
| 116 |
| EG001 | Two Doses of Dexamethasone | This group was the intervention group and received a dose of dexma | 0 | 116 | 0 | 116 | 10 | 116 |
|
| Difficulty sleeping | General disorders | Systematic Assessment | Reported difficulty sleeping |
|
| Moodswing/Agitation | Psychiatric disorders | Systematic Assessment | Reported mood swings/agitation |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Difficulty Sleeping |
|
| Mood swings/Agitation |
|
| Headache |
|
| Other |
|
| Multiple |
|