NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study

PHASE4CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Pain
Interventions
DRUG

Fentanyl (5 microgram/ml) prediluted ampoules

"Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.~Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation)."

Trial Locations (1)

221 85

Neonatal Intensive Care Unit, Skåne University Hospital, Lund

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

lead

Lund University

OTHER

NCT03897452 - NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study | Biotech Hunter | Biotech Hunter