BACKGROUND: Asthma remains a leading cause of hospitalization in children. It has been determined that the MDI is equally as effective as nebulized wet aerosol therapy for treatment of acute asthma in adults, and may even work better in children older than 2 years.1 The authors of this study investigated whether the same relationship holds true in children between the ages of 10 months and 4 years.
POPULATION STUDIED: The investigators enrolled 42 children aged 10 months to 4 years presenting to the emergency department of a large hospital in Israel. Children were not included if they had a history of cardiac disease or chronic respiratory disease (other than asthma), had an altered level of consciousness, or were in respiratory failure. Most subjects were referred from their primary care physicians to the emergency department because of the severity of their presentation.
STUDY DESIGN AND VALIDITY: This study was a randomized controlled double-blind double-dummy clinical trial. Subjects were randomly assigned to 2 groups. Randomization assignment was concealed. The first group received a standard dose of salbutamol (2.5 mg in 1.5 cc of normal saline) by nebulized aerosol therapy along with 4 puffs of placebo by MDI with a spacing device and facemask. The second group received 4 puffs of salbutamol (400 μg) by MDI with spacer and facemask along with 2 mL of normal saline by nebulized aerosol. Clinical scores (respiratory rate, pulse rate, pulse oximetry, wheezing, breath sounds, and retractions) were calculated at baseline and also 15 minutes after the conclusion of each respiratory treatment. Each patient received a total of 3 treatments delivered at 20-minute intervals. The study is well designed. The authors do not mention if any treatments were rendered by the referring physicians before arrival in the emergency department. The presence of antecedent b-agonist therapy could have affected the outcomes. This study was large enough to find a difference in the major outcomes (if one exists) but not to determine whether MDI therapy results in a change in the rate of hospitalization.
OUTCOMES MEASURED: The 2 major outcomes were respiratory rate and the patient’s clinical score. Minor outcomes included pulse rate and room air pulse oximetry. Hospitalization rates between the groups were also compared.
RESULTS: The study groups were similar at baseline. The reduction in respiratory rate and the improvement in patients’ clinical scores were similar between groups. Side effect rates were similar in the 2 groups. A total of 31% required hospitalization, but there was no difference in the rate of hospitalization between groups.
The use of a MDI with spacer and facemask is clinically equal to the use of nebulized aerosol for the delivery of b-agonist therapy in acutely wheezing infants between the ages of 10 months and 4 years. Symptoms resolve similarly with the 2 methods. This study was not large enough to determine whether one administration method is superior with regard to hospitalization rate, although a recent meta-analysis1 involving studies of older children demonstrated shorter stays in MDI-treated children. Education regarding the proper use of the MDI-spacer-facemask combination (ie, the facemask should cover the mouth and nose) in infants and children is a key component to ensuring therapeutic success.