Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit (IVA POP NICU)
Pain, Postoperative, Pain
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring acetaminophen, pain, neonate, infant, tylenol, paracetamol, postoperative, surgery
Eligibility Criteria
Inclusion Criteria: Neonates, admitted to McMaster Children's Hospital NICU Has had major open, thoracic or abdominal surgery (see appendix 1, table 6). Informed consent obtained from guardian(s) Exclusion Criteria: Hepatic dysfunction AST, ALT or Bilirubin > 3x upper limit of normal INR ≥ 3.0 or PT greater than 20s regardless of vitamin K administration Renal dysfunction Increase in serum creatinine ≥ 2x baseline (baseline: lowest value in first 5 days of hospitalization) Urine output < 0.5 mL/kg/h for ≥ 12h Allergy or intolerance to acetaminophen or fentanyl Acetaminophen administration within 24 hours of the end of surgery Nerve blocks or epidurals Refusal or withdrawal of consent Enrolment in another competing trial No later than 12 hours after the end of surgery 12 months post gestational age or greater in age Birthweight greater or equal to 2,500g. Discharged from the McMaster NICU
Sites / Locations
- McMaster Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Comparator
Placebo
Standard of care + IV acetaminophen: Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of IV acetaminophen every 4 or 6 hours at weight-appropriate doses based on the patient's gestational age.
Standard of care + placebo: Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of an IV saline placebo every 4 or 6 hours at a rate which would mimic their dose of acetaminophen.