Table 2

Inclusion and exclusion criteria for the PARASHUTE study

Inclusion criteriaExclusion criteria
  • Neonates any gestational age and weight of both sexes.

  • Postmenstrual age up to 44 full weeks at inclusion.

  • Intended treatment with intravenous paracetamol for any indication or intended treatment with oral paracetamol for one of the following indications: fractures, intracranial or extracranial haemorrhages, chest tubes, postoperative pain or painful skin lesions.

  • Informed written consent from both parents or legal guardian.

  • Inclusion can be postponed 24 hours after treatment start.

  • The responsible clinician finds the patient unsuitable for the study.

  • Hypersensitivity towards paracetamol.

  • Withdrawal criteria.

  • The responsible clinician finds that it is no longer appropriate for a patient to continue in the study.