To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events. Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up. Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Opioid Pain Medicine
Childens Hospital Zurich
Zurich, Switzerland
Pharmacokinetics (Area under the plasma concentration-time)
Area under the plasma concentration-time from the first to the last sample
Time frame: One Visit = approximately 6 hours
Pharmacokinetics (Maximum Plasma concentration)
Maximum Plasma concentration
Time frame: One Visit = approximately 6 hours
Pharmacokinetics (Time to reach Maximum Plasma concentration)
Time to reach Maximum Plasma concentration
Time frame: One Visit = approximately 6 hours
Pharmacokinetics (Half-life time)
Half-life time
Time frame: One Visit = approximately 6 hours
Pharmacokinetics (Bioavailability of Nalbuphine intranasal)
Bioavailability of Nalbuphine intranasal
Time frame: One Visit = approximately 6 hours
Effect on pain (Neonatal Infant Pain Score)
Effect on pain score: NIPS (Neonatal Infant Pain Score)
Time frame: One Visit = approximately 6 hours
Adverse Events
Safety will be evaluated with summary of Adverse Events
Time frame: One Visit = approximately 6 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.