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What is the dose of intravenous paracetamol for pain relief in neonates?
  1. Paola Mian1,
  2. Catherijne AJ Knibbe2,3,
  3. Dick Tibboel1,
  4. Karel Allegaert1,4
  1. 1 Intensive Care and Department of Paediatric Surgery, Erasmus MC Sophia Children’s Hospital, Rotterdam, The Netherlands
  2. 2 Division of Pharmacology, LACDR, Leiden University, Leiden, The Netherlands
  3. 3 Department of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands
  4. 4 Department of Development and Regeneration KU Leuven, Catholic University of Leuven, Leuven, Belgium
  1. Correspondence to Paola Mian, Erasmus MC-Sophia Children’s Hospital, room NA-1723, Wytemaweg 80, Rotterdam 3015 CN, The Netherlands; p.mian{at}

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Paracetamol (acetaminophen) is an effective analgesic and antipyretic. It is commonly prescribed to treat mild to moderate pain and fever in adults, children and neonates.1 Paracetamol can be administered orally, rectally or by intravenous route. It is reasonable to assume that intravenous administration improves the prediction in concentration profile compared with enteral administration, through elimination of variability in bioavailability and absorption.1 2 Due to its more predictable pharmacokinetic (PK) profile, intravenous paracetamol seems attractive to treat (pre)term neonates with pain. However, the question remains which dosage regimen has to be given. Therefore, we discuss what dose of intravenous paracetamol should be given to treat neonates with pain, taken into account current literature on both PK and pharmacodynamics (safety).

Dosing guidelines in neonates

In Europe, intravenous paracetamol is registered for short-term treatment of pain in term, but not preterm neonates, with a dose of 7.5 mg/kg every 6 hours. In the USA, intravenous paracetamol is unlicensed below 2 years of age because the efficacy/safety balance in infants and neonates is questioned.1 Despite this lack of labelled dosing information, intravenous paracetamol is widely …

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  • Contributors PM performed the systematic search, and KA verified this search. PM wrote the versions of the editorial, further adapted by DT, CK and KA.

  • Competing interests PM has been supported by the Sophia Stichting Wetenschappelijk Onderzoek (SSWO) (S16-08). Theresearch activities of KA are facilitated by the agency for innovation by Science and Technologyin Flanders (IWT) through the SAFEPEDRUG project (IWT/SBO 130033).

  • Provenance and peer review Commissioned; externally peer reviewed.