NCT05678244: IVA POP NICU

Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial

Status unknown Phase 4 Last updated 24 April 2023

What this trial tests

Phase 4 trial testing Acetaminophen in Pain, Postoperative in 60 participants. Status unknown.

Timeline

17 April 2023

Primary endpoint
1 August 2024

1 September 2024

Quick facts

Lead sponsor	McMaster Children's Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	17 April 2023
Primary completion	1 August 2024
Estimated completion	1 September 2024
Sites	1 location across Canada

Drugs / interventions tested

• Acetaminophen (Paracetamol) — full drug profile →
• Placebo

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Pain — all drugs for Pain →

Sponsor

McMaster Children's Hospital

Who can join

Under 12 Months, any sex, with Pain, Postoperative or Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recruitment rate
  Time frame: through study completion, an average of 1.5 years
  Mean number of patients randomized per month
• Follow up rate
  Time frame: 90 days
  Number of patients followed in completion from postoperative day 0 to 7
• Medication compliance
  Time frame: 7 days
  Number of patients who received at least 80% of doses of study drugs at the correct dose and interval
• Blinding index
  Time frame: 7 days
  Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP).
   Archer VA, Samiee-Zafarghandy S, Farrokyhar F, Briatico D, et al · · 2023 · PMID 37983228 · DOI 10.1371/journal.pone.0294519