Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit

The goal of this pilot randomized clinical trial is to determine the effect of the addition of IV acetaminophen to opioid-based pain regimes for infants admitted to the neonatal intensive care unit (NICU) after surgery.This is a pilot trial; the main goals are to make sure our study methods work before performing a larger study.The main clinical aims are:Determine if adding IV acetaminophen reduces painDetermine if adding IV acetaminophen reduces opioid useDetermine if adding IV acetaminophen reduces complicationsParticipants will be randomized to two groups:Comparator: Fentanyl and IV acetaminophen Control: Fentanyl and placeboPatients will receive either IV acetaminophen or placebo at regular intervals for seven days after surgery. Patients will be followed daily during that period. Charts will be reviewed at 90-days for final outcomes.

Inclusion Criteria:Neonates, admitted to McMaster Children's Hospital NICUHas had major open, thoracic or abdominal surgery (see appendix 1, table 6).Informed consent obtained from guardian(s)Exclusion Criteria:Hepatic dysfunctionAST, ALT or Bilirubin > 3x upper limit of normalINR ≥ 3.0 or PT greater than 20s regardless of vitamin K administrationRenal dysfunctionIncrease in serum creatinine ≥ 2x baseline (baseline: lowest value in first 5 days of hospitalization)Urine output < 0.5 mL/kg/h for ≥ 12hAllergy or intolerance to acetaminophen or fentanylAcetaminophen administration within 24 hours of the end of surgeryNerve blocks or epiduralsRefusal or withdrawal of consentEnrolment in another competing trialNo later than 12 hours after the end of surgery12 months post gestational age or greater in ageBirthweight greater or equal to 2,500g.Discharged from the McMaster NICU