Recruiting

Acetaminophen

Sponsor:

McMaster Children's Hospital

Code:

NCT05678244

Conditions

Pain, Postoperative

Pain

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Placebo

Study Details

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. 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

Study ID

NCT05678244

Start date

Apr 17, 2023

Status verified date

Apr, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: Placebo

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.

Interventions

Acetaminophen

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

Placebo

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

Primary outcome measure

  • Recruitment rate [ Time Frame: through study completion, an average of 1.5 years ]
  • Follow up rate [ Time Frame: 90 days ]
  • Medication compliance [ Time Frame: 7 days ]
  • Blinding index [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Victoria Archer, MD

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

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Victoria Archer, MD

5067219285vicki.archer@medportal.ca

More Information

Sponsor

McMaster Children's Hospital

Last update posted

Apr 25, 2023

Last verified

Apr, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster Children's Hospital on 2023-04-25.