Use of Dexamethasone in Pediatric Asthma Exacerbations

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Dexamethasone Sodium Phosphate Injection

• Registration Number: NCT02192827
• Lead Sponsor: University at Buffalo

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Study Start: 2015-04
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Results First Submitted: 2020-09-23
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Results First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• Children aged 2 to 20 years, from all race and ethnicity groups, with a known history of asthma who present to the Emergency Department of Women and Children's Hospital of Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible for the study. Patients with severe asthma exacerbations will require intravenous steroid therapy, therefore, they will not be enrolled in the study. The investigators plan to enroll patients from winter of 2014 to fall 2016.

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

• Children who have one of the following conditions will be excluded from the study: are less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of dexamethasone in emergency department.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose Dexamethasone	Dexamethasone Sodium Phosphate Injection	0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Two Dose Dexamethasone	Dexamethasone Sodium Phosphate Injection	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Returning to Care Following Discharge From the Emergency Department	5 days	The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.

Secondary Outcome Measures

Name	Time	Method
Reported Number of Days Until Symptom Resolution	5 days	Will determine number of days to symptom resolution, including missed school days.

Trial Locations

Locations (1)

Women and Children's Hospital Of Buffalo; 🇺🇸 Buffalo, New York, United States