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Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit

NCT05678244 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Pain

Interventions

DRUG

Acetaminophen

IV acetaminophen will be added to standard of care opioid based pain regimes.

DRUG

Placebo

In control group placebo will be added to standard of care opioid based pain regimes.

Sponsors & Collaborators

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Mark Walton, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-08-31
Completion
2024-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678244 on ClinicalTrials.gov