OBJECTIVE: To determine if administration of albuterol by a metered-dose inhaler with a spacer device is as efficacious as administration of albuterol by nebulizer to treat wheezing in children aged 2 years and younger. DESIGN: Double-blind, randomized, placebo-controlled clinical trial. SETTING:Pediatric emergency department. PATIENTS: From a convenience sample of wheezing children aged 2 to 24 months, 85 patients were enrolled in the nebulizer group and 83 in the spacer group. INTERVENTIONS: The nebulizer group received a placebo metered-dose inhaler with a spacer followed by nebulized albuterol. The spacer group received albuterol by a metered-dose inhaler with a spacer followed by nebulized isotonic sodium chloride solution. Treatments were given every 20 minutes by a single investigator blinded to group assignment. MAIN OUTCOME MEASURES: The primary outcome was admission rate. Pulmonary Index score and oxygen saturation were measured initially and 10 minutes after each treatment. RESULTS: The nebulizer group had a significantly higher mean (SD) initial Pulmonary Index score compared with the spacer group (7.6 [2.5] vs 6.6 [2.0]; P =.002). With the initial Pulmonary Index score controlled, children in the spacer group were admitted less (5% vs 20%; P =.05). Analyses also revealed an interaction between group and initial Pulmonary Index score; lower admission rates in the spacer group were found primarily in children having a more severe asthma exacerbation. CONCLUSION: Our data suggest that metered-dose inhalers with spacers may be as efficacious as nebulizers for the emergency department treatment of wheezing in children aged 2 years or younger.
RCT Entities:
OBJECTIVE: To determine if administration of albuterol by a metered-dose inhaler with a spacer device is as efficacious as administration of albuterol by nebulizer to treat wheezing in children aged 2 years and younger. DESIGN: Double-blind, randomized, placebo-controlled clinical trial. SETTING: Pediatric emergency department. PATIENTS: From a convenience sample of wheezingchildren aged 2 to 24 months, 85 patients were enrolled in the nebulizer group and 83 in the spacer group. INTERVENTIONS: The nebulizer group received a placebo metered-dose inhaler with a spacer followed by nebulized albuterol. The spacer group received albuterol by a metered-dose inhaler with a spacer followed by nebulized isotonic sodium chloride solution. Treatments were given every 20 minutes by a single investigator blinded to group assignment. MAIN OUTCOME MEASURES: The primary outcome was admission rate. Pulmonary Index score and oxygen saturation were measured initially and 10 minutes after each treatment. RESULTS: The nebulizer group had a significantly higher mean (SD) initial Pulmonary Index score compared with the spacer group (7.6 [2.5] vs 6.6 [2.0]; P =.002). With the initial Pulmonary Index score controlled, children in the spacer group were admitted less (5% vs 20%; P =.05). Analyses also revealed an interaction between group and initial Pulmonary Index score; lower admission rates in the spacer group were found primarily in children having a more severe asthma exacerbation. CONCLUSION: Our data suggest that metered-dose inhalers with spacers may be as efficacious as nebulizers for the emergency department treatment of wheezing in children aged 2 years or younger.
Authors: James A Hedrick; James W Baker; Arthur B Atlas; Aftab A Naz; William R Lincourt; Roopa Trivedi; Anna Ellworth; Angela M Davis Journal: Open Respir Med J Date: 2009-07-16