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Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Sponsor
University Children's Hospital, Zurich (Other)
Overall Status
Terminated
CT.gov ID
NCT03059511
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
10.3
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study
Actual Study Start Date :
Mar 3, 2017
Actual Primary Completion Date :
Jan 10, 2018
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intravenous

single iv application of nalbuphine 0.05mg/kg

Drug: Nalbuphine
Opioid Pain Medicine
Active Comparator: intranasal

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

Drug: Nalbuphine
Opioid Pain Medicine

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (Area under the plasma concentration-time) [One Visit = approximately 6 hours]

    Area under the plasma concentration-time from the first to the last sample

  2. Pharmacokinetics (Maximum Plasma concentration) [One Visit = approximately 6 hours]

    Maximum Plasma concentration

  3. Pharmacokinetics (Time to reach Maximum Plasma concentration) [One Visit = approximately 6 hours]

    Time to reach Maximum Plasma concentration

  4. Pharmacokinetics (Half-life time) [One Visit = approximately 6 hours]

    Half-life time

  5. Pharmacokinetics (Bioavailability of Nalbuphine intranasal) [One Visit = approximately 6 hours]

    Bioavailability of Nalbuphine intranasal

Secondary Outcome Measures

  1. Effect on pain (Neonatal Infant Pain Score) [One Visit = approximately 6 hours]

    Effect on pain score: NIPS (Neonatal Infant Pain Score)

  2. Adverse Events [One Visit = approximately 6 hours]

    Safety will be evaluated with summary of Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Days to 3 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childens Hospital Zurich Zurich Switzerland 8032

Sponsors and Collaborators

  • University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Eva Berger, Dr, Chlidrens Hospital Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT03059511
Other Study ID Numbers:
  • PK_Nalbuphin_iv_intranasal
First Posted:
Feb 23, 2017
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Nalbuphine

Study Results

No Results Posted as of Dec 14, 2021