title: Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  trialregister.nl Identifier: NTR1438.
authors.affiliation: Intensive Care and Department of Pediatric Surgery, Erasmus MC–Sophia Children's Hospital, Rotterdam, The Netherlands.
authors.forename: Ilse
authors.initials: I
authors.lastname: Ceelie
authors.forename: Saskia N
authors.initials: SN
authors.lastname: de Wildt
authors.forename: Monique
authors.initials: M
authors.lastname: van Dijk
authors.forename: Margreeth M J
authors.initials: MM
authors.lastname: van den Berg
authors.forename: Gerbrich E
authors.initials: GE
authors.lastname: van den Bosch
authors.forename: Hugo J
authors.initials: HJ
authors.lastname: Duivenvoorden
authors.forename: Tom G
authors.initials: TG
authors.lastname: de Leeuw
authors.forename: Ron
authors.initials: R
authors.lastname: Mathôt
authors.forename: Catherijne A J
authors.initials: CA
authors.lastname: Knibbe
authors.forename: Dick
authors.initials: D
authors.lastname: Tibboel
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000698:Analgesia / Q000379:methods; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D009020:Morphine / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*; D011182:Postoperative Care; D013514:Surgical Procedures, Operative; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D000082:Acetaminophen; D009020:Morphine