Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
NCT ID: NCT03059511
Last Updated: 2021-12-14
Study Results
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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TERMINATED
PHASE1
51 participants
INTERVENTIONAL
2017-03-03
2018-01-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intravenous
single iv application of nalbuphine 0.05mg/kg
Nalbuphine
Opioid Pain Medicine
intranasal
single intranasal application of nalbuphine 0.1mg/kg in infants.
Nalbuphine
Opioid Pain Medicine
Interventions
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Nalbuphine
Opioid Pain Medicine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
29 Days
3 Months
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Principal Investigators
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Eva Berger, Dr
Role: PRINCIPAL_INVESTIGATOR
Chlidrens Hospital Zurich
Locations
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Childens Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Pfiffner M, Gotta V, Pfister M, Vonbach P, Berger-Olah E. Pharmacokinetics and tolerability of intranasal or intravenous administration of nalbuphine in infants. Arch Dis Child. 2023 Jan;108(1):56-61. doi: 10.1136/archdischild-2022-323807. Epub 2022 Sep 13.
Other Identifiers
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PK_Nalbuphin_iv_intranasal
Identifier Type: -
Identifier Source: org_study_id