Optimizing Pain Treatment in Children On Mechanical Ventilation (NCT06994442)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (18 items).
Location: Arkansas Children's Hospital — Little Rock, Arkansas
Age range: 2 Months to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- 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
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (16 Sites)
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's National Hospital — Washington D.C., District of Columbia
- University of Michigan — Ann Arbor, Michigan
- Children's Hospital of Michigan — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Duke Children's Hospital & Health Center — Durham, North Carolina
- Rainbow Babies and Children's Hospital — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Penn State Health/Hershey Medical Center — Hershey, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- UT Southwestern Medical Center — Dallas, Texas
- Texas Children's Hospital/Baylor College of Medicine — Houston, Texas
- Primary Children's Medical Center — Salt Lake City, Utah
- Wisconsin Children's — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (212) 746-3056
Email: chr9008@med.cornell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mechanical Ventilation
- Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts — Columbus, Ohio
- DIAPHRAGM STRENGTH AND LUNG VOLUMES — Toronto, Ontario
- Analgesia-First Sedation in Trauma Patients — Long Beach, California
- Ketamine Sedation in the ICU (KANINE) RCT — Hamilton, Ontario
- Prognostic Estimates Among ICU Clinicians — Chicago, Illinois
Explore by condition: All Mechanical Ventilation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.