Optimizing Pain Treatment in Children On Mechanical Ventilation (NCT06994442) | Clinical Trial Compass
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
United States644 participantsStarted 2025-12-29
Plain-language summary
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. Even with strong doses of opioids, more than 90% of these children still feel pain. Other pain medicines, like acetaminophen (also called Tylenol) and ketorolac (also called Toradol), are available but aren't commonly used because we don't know if they help. The goal of this clinical trial is to test if acetaminophen and/or ketorolac can improve pain control and reduce the need for stronger pain medications (opioids) in these children.
To learn more about this, participants will be randomly placed in one of four study treatment groups. This means that a computer will decide by chance which group each participant is in, not the doctors running the study. Each group will receive a combination of intravenous acetaminophen, ketorolac or a harmless substance called a placebo. In this clinical trial, placebos help investigators see if the actual medications (acetaminophen and ketorolac) work better than something that doesn't contain medicine. By comparing participants who get the real medicine with those who get the placebo, investigators can find out if these medications effectively decrease pain.
Who can participate
Age range2 Months – 17 Years
SexALL
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Inclusion 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
Exclusion criteria
✕. 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
What they're measuring
1
Acute Pain Episodes
Timeframe: First 5 days of mechanical ventilation or until extubation, whichever comes first
Trial details
NCT IDNCT06994442
SponsorWeill Medical College of Cornell University
✕. 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 laboratory standards); OR
✕. 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 failure due to volume depletion); OR
✕. Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR