Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-01-10

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.

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Detailed Description

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Conditions

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Pharmacokinetic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous

single iv application of nalbuphine 0.05mg/kg

Group Type ACTIVE_COMPARATOR

Nalbuphine

Intervention Type DRUG

Opioid Pain Medicine

intranasal

single intranasal application of nalbuphine 0.1mg/kg in infants.

Group Type ACTIVE_COMPARATOR

Nalbuphine

Intervention Type DRUG

Opioid Pain Medicine

Interventions

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Nalbuphine

Opioid Pain Medicine

Intervention Type DRUG

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

Minimum Eligible Age

29 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No