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IV Acetaminophen for Postoperative Pain in Newborns (IVA POP NICU Trial)
Phase 4
Recruiting
Led By Mark Walton, MD
Research Sponsored by McMaster Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has had major open, thoracic or abdominal surgery (see appendix 1, table 6)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1.5 years
Awards & highlights
IVA POP NICU Trial Summary
This trial will test if giving IV acetaminophen to NICU babies after surgery reduces pain and opioid use, and lowers complications.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects of IV acetaminophen may include allergic reactions, liver enzyme changes leading to potential liver damage, and less commonly skin rashes or low blood pressure.
IVA POP NICU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had major surgery on my chest or abdomen.
IVA POP NICU Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blinding index
Follow up rate
Medication compliance
+1 moreSecondary outcome measures
Bowel movement
Daily Consumption of other analgesics
Daily fentanyl consumption
+8 moreOther outcome measures
Apnea
Bradycardia
Feeding intolerance
+8 moreIVA POP NICU Trial Design
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.
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Who is running the clinical trial?
McMaster Children's HospitalLead Sponsor
38 Previous Clinical Trials
17,265 Total Patients Enrolled
Mark Walton, MDPrincipal InvestigatorMcMaster University
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Eligibility Criteria:
This trial includes the following eligibility 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.I have had major surgery on my chest or abdomen.I have had nerve blocks or epidurals.Your kidney function, as measured by serum creatinine, has doubled from its original level during the first 5 days of your hospital stay.I took acetaminophen within 24 hours after my surgery ended.I have liver problems.My surgery was completed less than 12 hours ago.Your liver function tests show high levels of AST, ALT, or Bilirubin.Your blood clotting test shows a high risk of bleeding, even if you have taken vitamin K.Criterion: Babies being cared for in the NICU at McMaster Children's Hospital.You have been urinating very little for at least 12 hours.You are allergic to acetaminophen or fentanyl, or cannot tolerate them.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Comparator attained Food and Drug Administration endorsement?
"The safety of Comparator was rated a 3 given that it is already in the fourth phase of development, which confirms its approval."
Answered by AI
Are there still opportunities for individuals to participate in this clinical experiment?
"The clinicaltrial.gov data indicates this trial is not presently recruiting participants. This research study was initially posted on February 1st of 2023, and the most recent update was 9th of January in the same year. Despite that, there are 771 other studies actively enrolling patients right now."
Answered by AI
What are the projected results of this investigation?
"The primary goal of the trial, which will be tracked over a period averaging 1.5 years, is to measure follow-up rate. Secondary metrics include daily and total fentanyl consumption measured in mcg/kg as well as 24 hour recordings of other analgesic medications taken by patients recorded in mg or mcg / kg."
Answered by AI
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