Background: The role of aminophylline in the management of patients with severe asthma remains controversial. Children with severe asthma are treated initially with continuous BETA-2 agonists, inhaled anticholinergics and intravenous steroids. When expected improvement does not occur, aminophylline is considered as an adjunctive therapy, but there is no scientifically proven benefit in this addition. It is hoped that this study will provide objective data to answer this question.
Methods: A prospective, randomized, double blind, placebo controlled trial in patients > 30 days and up to 18 years of age, with status asthmaticus and admitted to the PICU. The clinical severity of the event was assessed before and during therapeutic interventions by using the Woods-Downes-Lecks clinical asthma score. Patients are randomized to treatment and placebo groups. The patients in the control group receive a loading dose of aminophylline followed by a continuous infusion of this drug. Patients in the control group receive a bolus of Normal Saline followed by a continuous infusion of this solution. A clinical pharmacist adjusted the infusion of aminophylline in the treatment group patients to achieve a level between 13-18 mcg/ml. Similar adjustments were made in the Normal Saline infusion in the control group to ensure the blinding.
Results: A total of 21 patients have been included in the study. Eleven of the 21 patients received aminophylline and ten received placebo. Variables from both groups were statistically compared. 1. There was a significant difference in the number of PICU days, with the aminophylline treated group requiring less days in the PICU (log rank and Wilcox test). (P---0.04>0.04). 2. No significant difference in initial asthma score and adverse effects during infusion of aminophylline or placebo. (P>-0.28 and >0.30 respectively). 3. There was no significant difference in the time of continuous albuterol required to achieve a clinical asthma score equal or less than 4 (significant clinical improvement), using log rank and Wilcox tests. (P->0.32->0.22) 4. No difference in complications (respiratory failure) or use of other medications such as intravenous Terbutaline or Magnesium Sulphate.
Conclusion: Our study suggests that aminophylline use may shorten the length of stay in the PICU, may not decrease the interval between admission and significant clinical improvement and may not decrease the incidence of complications. The cost of hospitalization may be decreased by using aminophylline in this patient population. The final analysis will be performed when a total of 25 patients are included in each group.
Luis Torero, MD, FAAP(*) and J C Maggi, MD, FAAP, FCCP. Department of Pediatric Critical Care and Pulmonary Medicine, Miller Children's at Long Beach Memorial Medical Center, Long Beach, CA.
COPYRIGHT 1999 American College of Chest Physicians
COPYRIGHT 2000 Gale Group
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