A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

Not Applicable

Completed

Brief Summary: This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.

Detailed Description: Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined.

Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.

Recruitment & Eligibility

Inclusion Criteria

Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.

Exclusion Criteria

Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease
Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.

Primary Outcome Measures

Name	Time	Method
Number of Participant's Admitted to the Hospital for Further Treatment	6 hours	Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.

Secondary Outcome Measures

Name	Time	Method
Emergency Department Length of Stay	6 hours	Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.
Number of Patients With Tachycardia After Treatment	6 hours	Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.
Number of Patients Requiring Ondansetron Dosing	6 hours	Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.
Number of Participants Requiring Repeat Visits	Within 7 days of initial presentation	Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.