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New treatment option for Mechanical Ventilation
Official title Optimizing Pain Treatment in Children On Mechanical Ventilation
ClinicalTrials.gov ID: NCT06994442
What this study is testing
What is Acetaminophen?
Acetaminophen is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mechanical ventilation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this clinical trial, investigators want to learn more about using non-opioid pain medications for children with acute respiratory failure. Right now, doctors give these children opioids to help with pain while they are on the ventilator, but investigators don't know if this is the best way to manage their pain.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- At least 2 months of age to 17 years 6 months; AND
- Acute Respiratory Failure requiring endotracheal intubation; AND
- Opioid infusion planned or started; AND
- Expected duration of Invasive Mechanical Ventilation \> 48 hours
You likely can't join if
- History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR
- Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR
- Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary...
- Platelet count \< 100,000/microliter; OR
- Known liver disease (defined as pre-existing diagnosis of hepatic insufficiency, or a serum ALT \> 5 times upper limit of normal or serum total...
See the full eligibility criteria
- At least 2 months of age to 17 years 6 months; AND
- Acute Respiratory Failure requiring endotracheal intubation; AND
- Opioid infusion planned or started; AND
- Expected duration of Invasive Mechanical Ventilation \> 48 hours
- History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR
- Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR
- Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR
- Platelet count \< 100,000/microliter; OR
- Known liver disease (defined as pre-existing diagnosis of hepatic insufficiency, or a serum ALT \> 5 times upper limit of normal or serum total bilirubin \> 2 times the upper limit of normal, as defined by hospital...
- Known kidney disease (defined as pre-existing diagnosis of renal insufficiency, or an estimated creatinine clearance \< 30 mL/min/m2 obtained within the previous 24-hours prior to eligibility, or high risk of renal...
- Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
- Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
- Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR
- Unable to obtain consent and randomize within 12 hours of eligibility, OR
- Positive pregnancy test; OR
- Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR
- Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
- Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
- Use of high dose NSAIDS within the prior 6 months, OR
- Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Washington D.C., District of Columbia, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Washington D.C., District of Columbia, United States; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Durham, North Carolina, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.