Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03059511

Enrollment

Registered

2017-02-23

Start date

2017-03-03

Completion date

2018-01-10

Last updated

2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic

Brief 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.

Interventions

DRUGNalbuphine

Opioid Pain Medicine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

29 Days to 3 Months

Healthy volunteers

Inclusion criteria

* Infants 29 days-3 months * Minimum Body weight 3.0 kg * Indications: septical work up * Parent has been informed about the study and has signed Informed Consent Form

Exclusion criteria

* Infants who were born prematurely (before 37 weeks gestation) * Known kidney or liver disease * Known chronic illness * Documented previous adverse reaction to nalbuphine * Treatment with a depressant drug within 5 days prior to study * Epistaxis, nose trauma (only for the intranasal application) * Barriere of language

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (Maximum Plasma concentration)	One Visit = approximately 6 hours	Maximum Plasma concentration
Pharmacokinetics (Half-life time)	One Visit = approximately 6 hours	Half-life time
Pharmacokinetics (Bioavailability of Nalbuphine intranasal)	One Visit = approximately 6 hours	Bioavailability of Nalbuphine intranasal
Pharmacokinetics (Area under the plasma concentration-time)	One Visit = approximately 6 hours	Area under the plasma concentration-time from the first to the last sample
Pharmacokinetics (Time to reach Maximum Plasma concentration)	One Visit = approximately 6 hours	Time to reach Maximum Plasma concentration

Secondary

Measure	Time frame	Description
Adverse Events	One Visit = approximately 6 hours	Safety will be evaluated with summary of Adverse Events
Effect on pain (Neonatal Infant Pain Score)	One Visit = approximately 6 hours	Effect on pain score: NIPS (Neonatal Infant Pain Score)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026