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Randomized Trial of the Addition of Ipratropium Bromide to Albuterol and Corticosteroid Therapy in Children Hospitalized Because of an Acute Asthma Exacerbation
Norma Goggin, MD, MRCP;
Colin Macarthur, MB, ChB, PhD;
Patricia C. Parkin, MD, FRCPC
Arch Pediatr Adolesc Med. 2001;155:1329-1334.
Objective To determine whether the addition of inhaled ipratropium bromide to
inhaled albuterol and systemic corticosteroid therapy was more efficacious
than inhaled albuterol and systemic corticosteroids alone in the inpatient
treatment of acute asthma exacerbations in children.
Design Double-blind, randomized, placebo-controlled trial.
Setting Pediatric inpatient unit of a tertiary urban hospital.
Participants Eighty children (aged 1-18 years) hospitalized because of an acute asthma
exacerbation.
Intervention Children were randomized to receive either nebulized ipratropium bromide,
250 µg, or nebulized isotonic sodium chloride solution, 1 mL. All children
received albuterol and systemic corticosteroids.
Main Outcome Measures The primary outcome variable was a validated clinical asthma score,
measured at baseline and every 6 hours for 36 hours. Secondary outcome measures
included the forced expiratory volume in 1 second, the oxygen saturation,
the number of doses of inhaled study drug, the time to an inhaled drug-dosing
interval of 4 hours, and the length of the hospital stay.
Results There were no differences between groups on baseline characteristics.
The intention-to-treat analysis, using repeated-measures analysis of variance,
showed no significant (P = .07) difference between the groups
in the clinical asthma score over time. There were also no significant differences
between groups on secondary outcomes.
Conclusion The addition of nebulized ipratropium bromide to nebulized ß2-agonist and corticosteroid therapy in the treatment of children hospitalized
because of asthma (following intensive emergency department treatment) confers
no extra benefit.
From the Department of Paediatrics, University of Toronto Faculty of
Medicine, and the Paediatric Outcomes Research Team (Drs Goggin, Macarthur,
and Parkin) and the Hospital for Sick Children Research Institute (Drs Macarthur
and Parkin), Toronto, Ontario; and the Department of Paediatrics, Waterford
Regional Hospital, Waterford, Ireland (Dr Goggin). The authors have no commercial,
proprietary, or financial interest in the products or companies described
in this article.
Corresponding author and reprints: Patricia C. Parkin, MD, FRCPC,
Division of Paediatric Medicine, Hospital for Sick Children, 555 University
Ave, Toronto, Ontario, Canada M5G 1X8 (e-mail: patricia.parkin{at}sickkids.ca).
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