Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

NCT03059511 | Terminated Phase 1 DMC

• 1 other identifier: PK_Nalbuphin_iv_intranasal
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics (Area under the plasma concentration-time)

  Area under the plasma concentration-time from the first to the last sample

  One Visit = approximately 6 hours

• Pharmacokinetics (Maximum Plasma concentration)

  Maximum Plasma concentration

  One Visit = approximately 6 hours

• Pharmacokinetics (Time to reach Maximum Plasma concentration)

  Time to reach Maximum Plasma concentration

  One Visit = approximately 6 hours

• Pharmacokinetics (Half-life time)

  Half-life time

  One Visit = approximately 6 hours

• Pharmacokinetics (Bioavailability of Nalbuphine intranasal)

  Bioavailability of Nalbuphine intranasal

  One Visit = approximately 6 hours

Secondary Outcomes (2)

• Effect on pain (Neonatal Infant Pain Score)

  One Visit = approximately 6 hours

• Adverse Events

  One Visit = approximately 6 hours

Study Arms (2)

intravenous

ACTIVE COMPARATOR

single iv application of nalbuphine 0.05mg/kg

Drug: Nalbuphine

intranasal

ACTIVE COMPARATOR

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

Drug: Nalbuphine

Interventions

Nalbuphine DRUG

Opioid Pain Medicine

intranasal; intravenous

Eligibility Criteria

• Age: 29 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

Childens Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36100355 DERIVED

MeSH Terms

Interventions

Nalbuphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Eva Berger, Dr

  Chlidrens Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 23, 2017
• Study Start: March 3, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)