Objectives
To propose approaches tailored to the specific needs of neonates, such as structured product development programs, with the ultimate goal to improve the safe and effective use of analgo-sedatives in these fragile patients.
Key findings
The feasibility and relevance of a structured product development program in neonates (optimal study design based on preliminary data; model development; internal, external and prospective evaluation; an individualized dosing regimen; long term safety; pharmacogenetics) is illustrated for the use of morphine.
Based on changes in clinical practices, similar development plans are in progress for short acting analgo-sedatives such as propofol, but are in need of tailored pharmacodynamic tools to assess and quantify effects. Furthermore, for drugs like paracetamol where there is already sufficient clinical pharmacology knowledge, attention needs to be given to long-term safety aspects. Finally, new covariates such as pharmacogenetics might further improve neonatal pain management, but clearly need to be integrated with other well established covariates like age or weight.
Summary
Product development programs for analgo-sedatives in neonates are needed. These programs should be tailored to their specific needs (short acting sedation, pain relief), should include long term safety, and should incorporate the exploration of newer covariates like pharmacogenetics.