Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: intravenous
single iv application of nalbuphine 0.05mg/kg
Opioid Pain Medicine
Active Comparator: intranasal
single intranasal application of nalbuphine 0.1mg/kg in infants.
Opioid Pain Medicine
- 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
- Pharmacokinetics (Maximum Plasma concentration) [ Time Frame: One Visit = approximately 6 hours ]Maximum Plasma concentration
- Pharmacokinetics (Time to reach Maximum Plasma concentration) [ Time Frame: One Visit = approximately 6 hours ]Time to reach Maximum Plasma concentration
- Pharmacokinetics (Half-life time) [ Time Frame: One Visit = approximately 6 hours ]Half-life time
- Pharmacokinetics (Bioavailability of Nalbuphine intranasal) [ Time Frame: One Visit = approximately 6 hours ]Bioavailability of Nalbuphine intranasal
- Effect on pain (Neonatal Infant Pain Score) [ Time Frame: One Visit = approximately 6 hours ]Effect on pain score: NIPS (Neonatal Infant Pain Score)
- Adverse Events [ Time Frame: One Visit = approximately 6 hours ]Safety will be evaluated with summary of Adverse Events
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
|Childens Hospital Zurich|
|Zurich, Switzerland, 8032|
|Principal Investigator:||Eva Berger, Dr||Chlidrens Hospital Zurich|