Present randomized, controlled, double-blind trial investigates the efficacy and safety of
early (<24 h) intravenous paracetamol therapy for pain medication in very small premature
infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The
pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are
studied.
This study recruits preterm infants born less than 32 weeks gestational age and treated at
the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked
from all parents. The first drug dose is given before 24 hours of age. Masked study drug is
paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is
20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the
closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain
are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of
possible side effects. After discharge from hospital, patients are examined at follow-up
clinic for the first year every 3 months and at 2 years of age.