Continuous Infusion of Fentanyl in Preterm on MV

PHASE3CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

July 31, 2010

Conditions
PainInfant, Premature, DiseasesRespiration; Insufficient or Poor, Newborn
Interventions
DRUG

Fentanyl

"The experimental drug will be diluted according to each NICU scheme and administered as an attach dose of 1 mcg/kg in 30' followed by continuous i.v. infusion of 1 mcg/kg/h. Infusion of the experimental drug has to begin within 24 hrs from the beginning of MV and has to be continued until the end of MV and not after 7 days of life. If the newborn is still on MV after the 7th day of life he/she will be treated for pain according to local protocols.~Open label boluses of Fentanyl during the study phase will be administered, in both groups when the EDIN pain score is \> 6 and before performing the following invasive procedures:Peripherally inserted central venous catheter positioning;Re-intubation;Lumbar puncture;Pneumothorax or hydrothorax drainage."

DRUG

5% glucose solution

ev continuous infusion

Trial Locations (1)

40138

St'Orsola-Malpighi General Hospital, Bologna

All Listed Sponsors
collaborator

Agenzia Italiana del Farmaco

OTHER_GOV

lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

NCT00571636 - Continuous Infusion of Fentanyl in Preterm on MV | Biotech Hunter | Biotech Hunter