Introduction: An intravenous (i.v.) formulation of paracetamol is available, but reports on its hepatic tolerance in neonates are limited. We therefore assessed hepatic tolerance of i.v. paracetamol in neonates.
Methods: In a single centre retrospective study, clinical data and hepatic enzyme profiles (ALT, AST, gammaGT) were collected in neonates treated with i.v. paracetamol between January 1, 2006 and October 1, 2007. Hepatic enzyme profiles were retrieved from 2 days before until 2 days after i.v. paracetamol administration. Mann-Whitney U-test was used to compare hepatic enzymes before, during, and after i.v. treatment. Correlations (Spearman rank) of hepatic enzymes with duration of treatment during i.v. administration were investigated.
Results: In 189 cases, 2360 administrations {postmenstrual age 38 (range 30-55) weeks, postnatal age 5 (1-182) days} were documented and 1132 hepatic enzyme observations were available in 149/189 cases. There was no significant increase in ALT, AST, or gammaGT when pretreatment observations (n = 310) were compared with observations during (n = 649) or during with after (n = 173) treatment, nor was there a significant increase during administration.
Conclusions: This retrospective study on hepatic tolerance provides evidence on safety aspects of i.v. paracetamol in neonates. Future studies should focus on dose-findings and pharmacodynamics of this formulation in neonates.