Sedation Clinical Trial
Official title:
Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients
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.
n/a
Time Perspective: Prospective
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|---|---|---|---|
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