Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

• Status: Suspended
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Children's Hospital, Zurich
• Treatments: Nalbuphine

Criteria

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