University hospital Motol
Prague, 15006, Czechia
NCT Number: NCT06171295
The goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in newborns during the continus caudal epidural analgesia. This type of analgesia is used for severly ill newborns. There is a need to lower the opioid doses for this population who is undergoing the surgery due to the life threading indication. In some cases it is considered to use the epidural analgesia for the sake of the patient.
The main question is:
Is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing for these patients?
Is this type of dosing of epidural analgesia safe and effective for newborns?
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Notify Me1 hour–5 week
All sexes
Interventional
Not applicable
Prague, 15006, Czechia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The blood draws in specified time points
Time frame: 144 hours
AE, SAE monitoring, opioid intake monitoring
Time frame: 144 hours
Pain managment monitoring - Comfort Neo Scale
Time frame: up to 5 years
Follow up visits with basic neurology examination
University Hospital, Motol
Other
Acronym: Levon
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