drugset / Trial / NCT03897452
NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
NaSingle-groupOpen-labelTreatment
Summary
The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-12-31
- Completion
- 2014-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 0.5 ug/kg | — |
| Subject | Fentanyl | Other / unclassified | 2 ug/kg | — |
Indications
No indication recorded.