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Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059511
Recruitment Status : Terminated (We conclude that the doses we administered were safe, but too low. We plan to continue the study with higher doses (0.1 mg/kg iv and 0.2 mg/kg intranasal).)
First Posted : February 23, 2017
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

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
Pharmacokinetic Drug: Nalbuphine Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : March 3, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pharmacokinetics (Area under the plasma concentration-time) [ Time Frame: One Visit = approximately 6 hours ]
    Area under the plasma concentration-time from the first to the last sample

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

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

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

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


Secondary Outcome Measures :
  1. Effect on pain (Neonatal Infant Pain Score) [ Time Frame: One Visit = approximately 6 hours ]
    Effect on pain score: NIPS (Neonatal Infant Pain Score)

  2. Adverse Events [ Time Frame: One Visit = approximately 6 hours ]
    Safety will be evaluated with summary of Adverse Events



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059511


Locations
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Switzerland
Childens Hospital Zurich
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Eva Berger, Dr Chlidrens Hospital Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03059511    
Other Study ID Numbers: PK_Nalbuphin_iv_intranasal
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: if someone ask for IPD

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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:
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Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents