IV Acetaminophen for Postoperative Pain in Newborns
(IVA POP NICU Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMark Walton, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: McMaster Children's Hospital

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mark Walton, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for newborns in the NICU at McMaster Children's Hospital who've had major surgery. They can join if they haven't taken acetaminophen recently, aren't in another study, and got consent from guardians. Babies with liver or kidney problems, certain blood issues, or allergies to the drugs being tested cannot participate.

Inclusion Criteria

Informed consent obtained from guardian(s)

I have had major surgery on my chest or abdomen.

Criterion: Babies being cared for in the NICU at McMaster Children's Hospital.

Exclusion Criteria

I am at least 12 months old.

You weighed at least 2,500 grams (about 5.5 pounds) at birth.

I have kidney problems.

See 12 more

Treatment Details

Interventions

Intravenous Acetaminophen (Other)

Trial OverviewThe study tests if IV acetaminophen added to opioid pain relief (fentanyl) after surgery helps reduce pain and opioid use in infants better than a placebo does. Infants are randomly assigned to either get acetaminophen or a fake drug (placebo) alongside fentanyl for seven days.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: ComparatorActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.