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

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 Overview

• Status: Terminated
• Conditions: Pharmacokinetic
• Intervention / Treatment: Drug: Nalbuphine

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Childens Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intravenous; single iv application of nalbuphine 0.05mg/kg	Drug: Nalbuphine; Opioid Pain Medicine
Active Comparator: intranasal; single intranasal application of nalbuphine 0.1mg/kg in infants.	Drug: Nalbuphine; Opioid Pain Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Eva Berger, Dr, Chlidrens Hospital Zurich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Nalbuphine
• Other Study ID Numbers: PK_Nalbuphin_iv_intranasal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: if someone ask for IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No