128
Participants
Start Date
December 31, 2007
Primary Completion Date
April 30, 2010
Study Completion Date
July 31, 2010
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."
5% glucose solution
ev continuous infusion
St'Orsola-Malpighi General Hospital, Bologna
Agenzia Italiana del Farmaco
OTHER_GOV
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER