Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Pharmacokinetic

Intervention / Treatment
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* Drug: Nalbuphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |