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Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

NCT03059511 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-12-14

No results posted yet for this study

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.

Conditions

  • Pharmacokinetic

Interventions

DRUG

Nalbuphine

Opioid Pain Medicine

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Eva Berger, Dr · Chlidrens Hospital Zurich

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2018-01-10
Completion
2018-01-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059511 on ClinicalTrials.gov