The Science Journal of the American Association for Respiratory Care

2006 OPEN FORUM Abstracts

High-Dose Continuous Nebulized Levalbuterol: Pediatric Safety Evaluation

Lisa Tyler, BS, RRT-NPS, CPFT, Timothy Andrews, MD, Erin McGintee, MD, Anoop Kotwal, Joseph Zorc, MD. The Children's Hospital of Philadelphia. Philadelphia, Pennsylvania.

Background: Levalbuterol (LEV), the single active R-isomer of racemic albuterol (RAC), is approved to treat acute asthma in children. There is little published data regarding the safety of high-dose continuous nebulized LEV.

Purpose: To evaluate the systemic effects of delivering a high dose regime of continuous nebulized LEV as compared with an equivalent dose of RAC.

Methods: 80 children ages 6-18 years with a severe asthma exacerbation were enrolled in this randomized, double-blind, controlled trial if they failed initial therapy with RAC and prednisone. Subjects received either 20mg/hr RAC or 10 mg/hr LEV and had continuous cardio-respiratory monitoring and hourly assessments of respiratory status. Serial blood R- and S-albuterol levels, glucose and potassium were obtained for the first 40 subjects.

Results: 41 subjects were randomized to LEV and received continuous therapy for a median of 18 hours (range 1-55). All subjects tolerated therapy and none required termination due to adverse effects. 70 subjects (33 RAC and 37 LEV) required at least 12 hours of therapy.  S levels rose substantially in the RAC group but other measures were similar (Table).

Conclusion: High-dose continuous LEV appears to be safe and well tolerated in children with similar systemic effects to an equivalent dose of RAC.

Table.  Measurements after 12 hours of continuous therapy

  N R level (pg/mL) S level (pg/mL) Potassium (mg/dL) Glucose (mg/dL) Heart rate (/ minute)
LEV 41 6563 ± 2385 2425 ± 1712 3.8 ± 1.0 180 ± 52 134 ± 12 
RAC 39 7558 ± 1819 24736 ± 5692 3.6 ± 0.4 151 ± 25 135 ± 20

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