Use of Dexamethasone in Pediatric Asthma Exacerbations



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:2 - 20
Updated:2/23/2019
Start Date:April 2015
End Date:March 2018

Use our guide to learn which trials are right for you!

Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department

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, peak
flow, 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 and measure
peak flows on a daily basis for 5 days. These 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 and measure peak flows in the ED. The peak flow meters are
offered to the patients as part of the asthma care path.

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, peak
flows, 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.

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.
We found this trial at
1
site
?
mi
from
Buffalo, NY
Click here to add this to my saved trials