Pharmacokinetics and pharmacodynamics of Acetaminophen in neonates.

Acetaminophen is the most common used analgesic and antipyretic drug in children and even prescribed in neonates to treat mild to moderate pain. Administered in therapeutic doses it is deemed to be safe, but only limited data are available of intravenous acetaminophen in term and preterm infants.

In this prospective blinded randomised trial, open-label, dose –finding all neonates (preterm and term) stratified by age groups admitted within the first 24 hours of life to the NICU with an indwelling arterial catheter for clinical purpose, are allocated to a specific dose regimen of intravenous acetaminophen (10mg/kg, 15 mg/kg or 20 mg/kg).

To test the hypothesis that acetaminophen is a safe and effective analgesia in neonates and to determine the optimal loading dose of intravenous Acetaminophen in neonates of different gestational age subgroups.

All neonates (preterm and term) stratified by age groups admitted within the first 24 hours of life to the NICU with an indwelling arterial catheter for clinical purpose, undergoing at least one painful procedure in the first 7 days of life.

Patients will be randomly allocated to a specific dose regimen of intravenous acetaminophen (10mg/kg, 15 mg/kg or 20 mg/kg) when they need to endure a painful procedure (i.v placement, insertion of a peripheral venous line) in the first week after birth.