Paracetamol (Acetaminophen) Efficacy and Safety in the Newborn

Abstract: Neonates can perceive pain, therefore an adequate analgesic therapy is a major issue not only from an ethical perspective but
also to improve short- and long-term outcome. Fever during the neonatal period requires hospitalization and needs a treatment with an
antipyretic agent because of the high risk of severe complications.
Paracetamol (acetaminophen), the most commonly prescribed drug in paediatric patients for its analgesic and antipyretic effects, is the
only agent recommended for use as an antipyretic in the newborn and has been recently proposed as a supplement therapy to opioids for
postoperative analgesia.
This article aims to give an updated overview on the use of paracetamol in newborns by presenting its pharmacological profile (mechanism
of action, pharmacokinetics), recommendations for dosing regimens (oral or rectal administration: 25-30 mg/kg/day in preterm neonates
of 30 weeks’ gestation, 45 mg/kg/day in preterm neonates of 34 weeks’ gestation, 60 mg/kg/day in term neonates; i.v. administration:
indicatively 20-40 mg/kg/day depending on gestational age, with some differences among various guidelines) and clinical uses
(more commonly as analgesic/antipyretic by oral or rectal route, but also i.v. in anaesthesia for postoperative analgesia and painful procedures
in Neonatal Intensive Care Units). Moreover, drug tolerability is discussed in the light of its potential hepatotoxicity and the unique
characteristics of the newborn patient.
By analyzing the available literature and the dosing guidelines, a mismatch exists between the current clinical use of paracetamol and the
recommendations, suggesting a cautious approach particularly in extremely preterm neonates.