The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure. Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).
Neonatal Intensive Care Unit, Skåne University Hospital
Lund, Sweden
Pharmacokinetics; fentanyl clearance
Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
Time frame: 48 hours
Pharmacokinetics; fentanyl clearance
The serum concentration values will be analysed as Area under the curve, AUC
Time frame: 6 hours
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)
Background activity
Time frame: 6 hours
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),
Seizure activity
Time frame: 6 hours
Pharmacodynamics, change in vital parameters
Change in heart rate
Time frame: 6 hours
Pharmacodynamics, change in vital parameters
Change in mean arterial blood pressure
Time frame: 6 hours
Pharmacodynamics, change in vital parameters
Change in near infrared spectroscopy
Time frame: 6 hours
Pharmacodynamics, behavioural response
Pain assessment with the Premature Infant Pain Profile-revised (PIPP) score for procedural pain (0-21, with the highest value if strong pain in extremely preterm infants)
Time frame: 6 hours
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Pharmacodynamics, hormonal response
Blood levels of cortisol
Time frame: 48 hours