Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

University of Zurich (UZH)

Status and phase: Terminated; Phase 1

Conditions: Pharmacokinetic

Treatments: Drug: Nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03059511

PK_Nalbuphin_iv_intranasal

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 29 days to 3 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

intravenous

Active Comparator group

Description:

single iv application of nalbuphine 0.05mg/kg

Treatment:

Drug: Nalbuphine

intranasal

Active Comparator group

Description:

single intranasal application of nalbuphine 0.1mg/kg in infants.

Treatment:

Drug: Nalbuphine