Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Phase 1

Terminated

• Conditions: Pharmacokinetic
• Interventions: Drug: Nalbuphine

• Registration Number: NCT03059511
• Lead Sponsor: University Children's Hospital, Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-03-03
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous	Nalbuphine	single iv application of nalbuphine 0.05mg/kg
intranasal	Nalbuphine	single intranasal application of nalbuphine 0.1mg/kg in infants.

Primary Outcome Measures

Name	Time	Method
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 (Maximum Plasma concentration)	One Visit = approximately 6 hours	Maximum Plasma concentration
Pharmacokinetics (Half-life time)	One Visit = approximately 6 hours	Half-life time
Pharmacokinetics (Time to reach Maximum Plasma concentration)	One Visit = approximately 6 hours	Time to reach Maximum Plasma concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Childens Hospital Zurich; 🇨🇭 Zurich, Switzerland