Women and Children's Hospital Of Buffalo
Buffalo, New York, 14222, United States
NCT Number: NCT02192827
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.
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Notify Me2 year–20 year
All sexes
Interventional
Phase 3
Buffalo, New York, 14222, United States
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: 5 days
The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.
Time frame: 5 days
Will determine number of days to symptom resolution, including missed school days.
Time frame: 5 days
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.
University at Buffalo
Other
Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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