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Evaluation of Sedation in Newborns

Medical University of Vienna · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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neonatenewbornsedation
Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team. The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.
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