Optimizing Pain Treatment in Children On Mechanical Ventilation
Key facts
- Who runs it
- Weill Medical College of Cornell University
- Where
- Ann Arbor, Charleston, Cleveland, Columbus, Dallas, Detroit, Durham, Hershey, Houston, Little Rock, Milwaukee, Minneapolis, Philadelphia, Pittsburgh, Salt Lake City, and Washington D.C., United StatesSee the 16 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 644 people, planned
- Started
- 29 Dec 2025
- Expected to end
- 31 Aug 2029
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Acetaminophen
- Ketorolac
- Placebo
- Record updated
- 29 October 2026
Who can take part
- Age
- 2 months to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR
- Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
- Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
- Use of high dose NSAIDS within the prior 6 months, OR
- 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
- Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
- Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis
- 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 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
- Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; 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
- Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Erin Carlton, MDTaking people
- Medical University of South CarolinaCharleston, United StatesContact: John Costello, MDTaking people
- Rainbow Babies and Children's HospitalCleveland, United StatesContact: Joseph Kohne, MDTaking people
- Nationwide Children's HospitalColumbus, United StatesContact: Ambrish Patel, MDTaking people
- UT Southwestern Medical CenterDallas, United StatesContact: Stephanie Hsu, MDNot yet recruiting
- Children's Hospital of MichiganDetroit, United StatesContact: Kathleen Meert, MDTaking people
- Duke Children's Hospital & Health CenterDurham, United StatesContact: Christoph Hornik, MDTaking people
- Penn State Health, Hershey Medical CenterHershey, United StatesContact: Neal Thomas, MDTaking people
- Texas Children's Hospital/ Baylor College of MedicineHouston, United StatesContact: Ayse Arikan, MDTaking people
- Arkansas Children's HospitalLittle Rock, United StatesContact: Ronald Sanders, MDTaking people
- Wisconsin Children'sMilwaukee, United StatesContact: Nathan Thompson, MDTaking people
- University of MinnesotaMinneapolis, United StatesContact: Joseph Resch, MDTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Heather Wolfe, MDTaking people
- University of PittsburghPittsburgh, United StatesContact: Ericka Fink, MDTaking people
- Primary Children's Medical CenterSalt Lake City, United StatesContact: Jill Sweney, MDTaking people
- Children's National HospitalWashington D.C., United StatesContact: Sonali Basu, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- Intravenous Acetaminophen (IV-A) + Intravenous PlaceboTreatment being tested
Participants receive intravenous acetaminophen and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Treatment: Acetaminophen and Placebo
- Intravenous Ketorolac (IV-K) + Intravenous PlaceboTreatment being tested
Participants receive intravenous ketorolac and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Treatment: Ketorolac and Placebo
- Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K)Treatment being tested
Participants receive intravenous acetaminophen and intravenous ketorolac every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Treatment: Acetaminophen and Ketorolac
- Intravenous Placebo + Intravenous PlaceboPlacebo, for comparison
Participants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 October 2026