Over the last decade increasingly RCT’s have been published about optimal dosing of opioids and benzodiazepines in critically ill children of different age groups.
In this way progress is made about optimal dosing as well as combination of therapies against the background of the use of novel ways of trial design.
To this effect the application of population pharmacokinetics-pharmacodynamics (NON-MEM) using spare data have guided the design of trials preceded by in vitro simulation and prediction of dose effect responses.
Both in the premature infant as well as in the so-called surgical newborn, dosages have been adjusted based on solid observational and experimental data sets for which the results should be evaluated. Apart from short term pharmacodynamic parameters such as validated pain scores, and eventually pharmacokinetic data analysis potentially equally important is the evaluation of long term consequences both of neonatal pain and the use of opioids. Experimental data have revealed increased neuro apoptosis in the developing brain. The data of a number of RCT’s conducted by our group will be combined with prospective longitudinal data recently acquired combining quantitative sensory testing (QST) under conditions of fMRI.
In this way the question whether neonatal pain and/or opioid use results in altered pain response and long term negative sequelae can be answered.
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