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Optimizing Pain Treatment in Children On Mechanical Ventilation

RecruitingPhase 3Ages 2 Months - 17 YearsAllWeill Medical College of Cornell University
NCT06994442 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. At least 2 months of age to 17 years 6 months; AND 2. Acute Respiratory Failure requiring endotracheal intubation; AND 3. Opioid infusion planned or started; AND 4. Expected duration of Invasive Mechanical Ventilation \> 48 hours Exclusion Criteria: 1. History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR 2. Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR 3. Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR 4. Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR 5. Platelet count \< 100,000/microliter; OR 6. 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 7. 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 8. Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR 9. Cardiac bypass surgery within the past 24 hours prior to eligibility; OR 10. Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR 11. Unable to obtain consent and randomize within 12 hours of eligibility, OR 12. Positive pregnancy test; OR 13. Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR 14. Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR 15. Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR 16. Use of high dose NSAIDS within the prior 6 months, OR 17. Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis
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What it tests

  • Acetaminophen
  • Ketorolac
  • Placebo
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Where

16 sites
Arkansas Children's Hospital
Little Rock, United States
Children's National Hospital
Washington D.C., United States
University of Michigan
Ann Arbor, United States
Children's Hospital of Michigan
Detroit, United States
University of Minnesota
Minneapolis, United States
Duke Children's Hospital & Health Center
Durham, United States
Rainbow Babies and Children's Hospital
Cleveland, United States
Nationwide Children's Hospital
Columbus, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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