TY - JOUR T1 - Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: A randomized controlled trial AU - Ceelie I, de Wildt SN, van Dijk M, et al Y1 - 2013/01/09 N1 - 10.1001/jama.2012.148050 JO - JAMA SP - 149 EP - 154 VL - 309 IS - 2 N2 - Importance  Continuous morphine infusion as standard postoperative analgesic therapy in young infants is associated with unwanted adverse effects such as respiratory depression.Objective  To determine whether intravenous paracetamol (acetaminophen) would significantly (>30%) reduce morphine requirements in neonates and infants after major surgery.Design, Setting, and Patients  Single-center, randomized, double-blind study conducted in a level 3 pediatric intensive care unit in Rotterdam, the Netherlands. Patients were 71 neonates or infants younger than 1 year undergoing major thoracic (noncardiac) or abdominal surgery between March 2008 and July 2010, with follow-up of 48 hours.Interventions  All patients received a loading dose of morphine 30 minutes before the end of surgery, followed by continuous morphine or intermittent intravenous paracetamol up to 48 hours postsurgery. Infants in both study groups received morphine (boluses and/or continuous infusion) as rescue medication on the guidance of the validated pain assessment instruments.Main Outcome Measures  Primary outcome was cumulative morphine dose (study and rescue dose). Secondary outcomes were pain scores and morphine-related adverse effects.Results  The cumulative median morphine dose in the first 48 hours postoperatively was 121 (interquartile range, 99-264) μg/kg in the paracetamol group (n = 33) and 357 (interquartile range, 220-605) μg/kg in the morphine group (n = 38), P < .001, with a between-group difference that was 66% (95% CI, 34%-109%) lower in the paracetamol group. Pain scores and adverse effects were not significantly different between groups.Conclusion and Relevance  Among infants undergoing major surgery, postoperative use of intermittent intravenous paracetamol compared with continuous morphine resulted in a lower cumulative morphine dose over 48 hours.Trial Registration  trialregister.nl Identifier: NTR1438 SN - 0098-7484 M3 - doi: 10.1001/jama.2012.148050 UR - http://dx.doi.org/10.1001/jama.2012.148050 ER -