Comparison of intravenous terbutaline versus normal saline in pediatric patients on continuous high-dose nebulized albuterol for status asthmaticus.

OBJECTIVE: To determine if the addition of intravenous terbutaline provides any clinical benefit to children with acute severe asthma already on continuous high-dose nebulized albuterol.
METHODS: We conducted a prospective, randomized, double blind, placebo-controlled trial on pediatric patients with acute severe asthma presenting to a large inner city tertiary children's emergency department. Consecutive patients between 2 and 17 years of age who failed acute asthma management and needed intensive care unit admission underwent informed consent and were enrolled into the study. Patients not requiring intubation were randomized to receive either intravenous terbutaline or intravenous normal saline while on continuous high-dose nebulized albuterol, ipratropium bromide, and systemic corticosteroids. Outcome measures included a clinical asthma severity score, hours on continuous nebulized albuterol, and duration of stay in the pediatric intensive care unit. In addition, electrocardiograms, electrolytes, lactic acid, and troponin I levels were obtained at routine intervals during the first 24 hours after admission. Patients who significantly worsened while enrolled in the study received intravenous aminophylline according to protocol.
RESULTS: Forty-nine patients were enrolled in the study. Patients on terbutaline had a mean improvement in the clinical asthma severity score over the first 24 hours of 6.5 points compared with 4.8 points in the placebo group (P = 0.073). Patients on terbutaline spent 38.19 hours on continuous nebulized albuterol compared with their placebo counterparts who spent 51.93 hours (P = 0.25). The length of stay in the PICU was on average 12.95 hours longer for those patients in the placebo group as compared with the terbutaline group (P = 0.345). One patient was removed from the study for a significant cardiac dysrhythmia. This patient was in the terbutaline group and recovered without complications. Troponin I values at 12 hours and 24 hours were elevated in 3 patients each, all within the terbutaline group.
CONCLUSIONS: No outcome measures demonstrated statistical significance. Outcome measures revealed a trend toward improvement in the terbutaline group. Before recommending routine use of intravenous terbutaline for acute severe asthma, further study to determine safety and efficacy is necessary.

RCT Entities:   Population Interventions Outcomes