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Abstract:

In addition to maturational changes, both major pathophysiological alterations and therapeutic interventions related to critical illness affect drug disposition and effects in children. However, appropriate drug dosing to result in appropriate drug exposure in critically ill children is rarely studied. Given the ethical issues and practical constraints, clinical trials in critically ill children are more difficult to perform. The introduction of new consent procedures, establishment of international trial consortia, minimal risk trial designs and quantitative modelling tools opens new horizons for pediatric drug research in this most vulnerable patient population.