Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Pharmacokinetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03059511
• Other study ID #: PK_Nalbuphin_iv_intranasal
• Status: Terminated
• Phase: Phase 1
• Start date: March 3, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: December 2021
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetic

Intervention

Drug:
• Nalbuphine
Opioid Pain Medicine

Locations

Country	Name	City	State
Switzerland	Childens Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetics (Maximum Plasma concentration)	Maximum Plasma concentration	One Visit = approximately 6 hours
Primary	Pharmacokinetics (Time to reach Maximum Plasma concentration)	Time to reach Maximum Plasma concentration	One Visit = approximately 6 hours
Primary	Pharmacokinetics (Half-life time)	Half-life time	One Visit = approximately 6 hours
Primary	Pharmacokinetics (Bioavailability of Nalbuphine intranasal)	Bioavailability of Nalbuphine intranasal	One Visit = approximately 6 hours
Secondary	Effect on pain (Neonatal Infant Pain Score)	Effect on pain score: NIPS (Neonatal Infant Pain Score)	One Visit = approximately 6 hours
Secondary	Adverse Events	Safety will be evaluated with summary of Adverse Events	One Visit = approximately 6 hours