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|