Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.
At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score. Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.
Study Type
OBSERVATIONAL
Enrollment
25
Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
Time frame: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam
Duration of mechanical ventilation
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Sedation depth
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Length of stay at the intensive care unit (ICU)
Time frame: Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks
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