Trials / Terminated
TerminatedNCT03059511
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- University Children's Hospital, Zurich · Academic / Other
- Sex
- All
- Age
- 29 Days – 3 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nalbuphine | Opioid Pain Medicine |
Timeline
- Start date
- 2017-03-03
- Primary completion
- 2018-01-10
- Completion
- 2018-01-10
- First posted
- 2017-02-23
- Last updated
- 2021-12-14
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03059511. Inclusion in this directory is not an endorsement.