Use of Dexamethasone in Pediatric Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dexamethasone Sodium Phosphate Injection
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Asthma; Exacerbation; Dexamethasone