Optimizing Pain Treatment in Children On Mechanical Ventilation (NCT06994442)
๐ฉบ 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: Review the eligibility criteria below.
Location: Arkansas Children's Hospital โ Little Rock, Arkansas
Age range: 2 Months to 17 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (16 Sites)
- Arkansas Children's Hospital โ Little Rock, Arkansas
- Children's National Hospital โ Washington D.C., District of Columbia
- University of Michigan โ Ann Arbor, Michigan
- Children's Hospital of Michigan โ Detroit, Michigan
- University of Minnesota โ Minneapolis, Minnesota
- Duke Children's Hospital & Health Center โ Durham, North Carolina
- Rainbow Babies and Children's Hospital โ Cleveland, Ohio
- Nationwide Children's Hospital โ Columbus, Ohio
- Penn State Health/Hershey Medical Center โ Hershey, Pennsylvania
- Children's Hospital of Philadelphia โ Philadelphia, Pennsylvania
- University of Pittsburgh โ Pittsburgh, Pennsylvania
- Medical University of South Carolina โ Charleston, South Carolina
- UT Southwestern Medical Center โ Dallas, Texas
- Texas Children's Hospital/Baylor College of Medicine โ Houston, Texas
- Primary Children's Medical Center โ Salt Lake City, Utah
- Wisconsin Children's โ Milwaukee, Wisconsin
๐ 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.
๐ฐ 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 ยง 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 โ Columbus, Ohio
- DIAPHRAGM STRENGTH AND LUNG VOLUMES โ Toronto, Ontario
- Ketamine Sedation in the ICU (KANINE) RCT โ Hamilton, Ontario
- Analgesia-First Sedation in Trauma Patients โ Long Beach, California
- Prognostic Estimates Among ICU Clinicians โ Chicago, Illinois
Explore by condition: All Mechanical Ventilation clinical trials
๐ก 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.