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 |