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IV Acetaminophen for Postoperative Pain in Newborns (IVA POP NICU Trial)
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.
IVA POP NICU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIVA POP NICU Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IVA POP NICU Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Comparator
- Group 2: Placebo
- 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.
- 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
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."
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."
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."
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