The pharmacokinetics of intravenous salbutamol in pediatric status asthmaticus: a pilot study.

In children, the standard therapy for a severe status asthmaticus, unresponsive
to inhaled bronchodilators and systemic corticosteroids, is intravenous
salbutamol. Although intravenous salbutamol is frequently used in children in a
wide range, pharmacokinetic data are scarce. To date, there are insufficient
data to guide initial and subsequent dosing recommendation for its intravenous
use in children. Especially the need for a loading dose needs to be addressed.
Therefore, pharmacokinetic data are needed to guide initial dosing strategies
of intravenous salbutamol in children. Because we will not have enough plasma
salbutamol concentrations before start of intravenous salbutamol we want to
extent the study and determine plasma salbutamol concentrations before and one
hour after the start of salbutamol nebulisation.

The primary objective is to explore the pharmacokinetic parameters of
intravenous salbutamol in pediatric patients admitted to the intensive care
unit.
Secondary objectives are to explore a possible relationship between dose,
plasma levels, bronchodilating effects and side effects of intravenous
salbutamol and to design initial dosing guidelines to optimize intravenous
salbutamol therapy in children with severe asthma.

A pilot population pharmacokinetic-pharmacodynamic study.

Patients will be treated according to the standard management protocol of
status asthmaticus. Two
blood samples will be taken together with bloodsampling for clinical purposes
and will be used for pharmacokinetic analysis. The study can only be carried
out in this population as pharmacokinetic results from adults or healthy
children cannot be extrapolated to children with status
asthmaticus.