Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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:

1. Determine if adding IV acetaminophen reduces pain

2. Determine if adding IV acetaminophen reduces opioid use

3. Determine if adding IV acetaminophen reduces complications

Participants will be randomized to two groups:

Comparator: Fentanyl and IV acetaminophen Control: Fentanyl and placebo

Patients 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster Children's Hospital
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

1. Neonates, admitted to McMaster Children's Hospital NICU

2. Has had major open, thoracic or abdominal surgery (see appendix 1, table 6).

3. Informed consent obtained from guardian(s)

Exclusion Criteria:

1. Hepatic dysfunction

• AST, ALT or Bilirubin > 3x upper limit of normal

• INR ≥ 3.0 or PT greater than 20s regardless of vitamin K administration

2. 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

3. Allergy or intolerance to acetaminophen or fentanyl

4. Acetaminophen administration within 24 hours of the end of surgery

5. Nerve blocks or epidurals

6. Refusal or withdrawal of consent

7. Enrolment in another competing trial

8. No later than 12 hours after the end of surgery

9. 12 months post gestational age or greater in age

10. Birthweight greater or equal to 2,500g.

11. Discharged from the McMaster NICU