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Single-centre audit on the use of intravenous paracetamol in neonates


An intravenous formulation of paracetamol is available, but remains off-label in patients below 10 kg although pharmacokinetics during repeated intravenous administration were documented and dosing regimes suggested [1, 2]. We therefore retrospectively evaluated aspects of the administration of intravenous paracetamol in neonates.


A single-centre retrospective study. Data were collected in neonates born and admitted between 1 January 2006 and 1 October 2007 to whom intravenous paracetamol was administered. In these patients, clinical data (age, duration of treatment, switch to oral treatment, liver enzymes during and up to 2 days after intravenous treatment) were retrieved. Correlations (Spearman rank) of hepatic enzymes with duration of treatment (hours) and differences in liver enzymes during/after (Mann–Whitney U test) were investigated.


Information on 2,360 administrations in 189 cases (postmenstrual age 38 (range 30–55) weeks, postnatal age 5 (1–182) days) was available. The median duration of administration was 48 (6–480) hours. The indication for initiation of intravenous paracetamol was postoperative analgesia in about 50% of cases, of whom the most frequent surgical interventions were cardiac surgery (39 cases), abdominal surgery (31 cases), thoracic surgery (16 cases) or neurosurgery (seven cases). Switch to oral treatment was only documented in 68/189 cases, end of paracetamol administration in 84 cases and insufficient analgesia (unscheduled initiation of opioids) in 23 cases. Six hundred and forty-nine observations on liver enzymes (ALT 280, AST 284, γGT 85) during and 174 (74, 75 and 25, respectively) after intravenous administration were available. No significant correlations between liver enzymes and duration of administration were observed and there was no significant difference in liver enzymes during versus after intravenous administration.


The current observations in 189 (pre)term neonates suggest that intravenous paracetamol does not alter hepatic enzymes profiles during or after intravenous administration in this specific population, and therefore seems to be a safe drug. The switch to oral treatment has only been observed in a relatively limited number of patients, probably reflecting the need to implement strategies to facilitate this switch.


  1. Anderson B, et al.: Pediatr Anesth. 2005, 15: 282-292. 10.1111/j.1460-9592.2005.01455.x

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  2. Allegaert K, et al.: Pediatr Anesth. 2007, 17: 811-812. 10.1111/j.1460-9592.2007.02227.x

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Vanhole, C., Allegaert, K., van Beek, F. et al. Single-centre audit on the use of intravenous paracetamol in neonates. Crit Care 12 (Suppl 2), P278 (2008).

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