Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit

NCT05678244 | Unknown Phase 4 DMC

• 1 other identifier: 14887-GRA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine if adding IV acetaminophen reduces pain
2. 2.Determine if adding IV acetaminophen reduces opioid use
3. 3.Determine if adding IV acetaminophen reduces complications

Conditions

Pain, Postoperative; Pain

Keywords

acetaminophen; pain; neonate; infant; tylenol; paracetamol; postoperative; surgery

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Mean number of patients randomized per month

  through study completion, an average of 1.5 years

• Follow up rate

  Number of patients followed in completion from postoperative day 0 to 7

  90 days

• Medication compliance

  Number of patients who received at least 80% of doses of study drugs at the correct dose and interval

  7 days

• Blinding index

  Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment

  7 days

Secondary Outcomes (11)

• Postoperative Pain

  every 6 hours for entire study period (7 days after surgery)

• Daily fentanyl consumption

  daily for 7 days

• Total fentanyl consumption

  7 days

• Daily Consumption of other analgesics

  daily for 7 days

• Total consumption of other analgesics

  7 days

Other Outcomes (11)

• Vomiting

  7 days

• NG/Vygone

  90 days

• Reintubation

  90 days

Study Arms (2)

Comparator

ACTIVE COMPARATOR

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.

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Acetaminophen DRUG

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

Comparator

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• months post gestational age or greater in age
• Birthweight greater or equal to 2,500g.
• Discharged from the McMaster NICU

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Related Publications (1)

• Archer VA, Samiee-Zafarghandy S, Farrokyhar F, Briatico D, Braga LH, Walton JM. Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP). PLoS One. 2023 Nov 20;18(11):e0294519. doi: 10.1371/journal.pone.0294519. eCollection 2023.

  PMID: 37983228 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mark Walton, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Archer, MD

CONTACT

506-721-9285; vicki.archer@medportal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: IV acetaminophen and saline appear identical in solution. They will be administered at identical rates. Care providers, participants' parents, investigators, outcomes assessors, and statisticians will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Principal Investigator

Model Details: Patients will be randomized to the control or comparator group. There will be 60 patients enrolled, with 30 patients per arm.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 10, 2023
• Study Start: April 17, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)