Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Phase 1 Terminated 51 enrolled University Children's Hospital, Zurich

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2017-03-03
Primary completion: 2018-01-10
Completion: 2018-01-10

Publications

Pfiffner M, Gotta V, Pfister M, Vonbach P, Berger-Olah E. Pharmacokinetics and tolerability of intranasal or intravenous administration of nalbuphine in infants. Arch Dis Child. 2023 Jan;108(1):56-61. doi: 10.1136/archdischild-2022-323807. Epub 2022 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Nalbuphine	Small molecule	0.05 mg/kg	Intravenous
Comparator	Nalbuphine	Small molecule	0.1 mg/kg	Intravenous

Indications

No indication recorded.