Better pain relief for children on breathing machines
Optimizing Pain Treatment In Children On Mechanical ventilation (OPTICOM)
Comparing whether adding acetaminophen or ketorolac to usual opioid care helps children on mechanical ventilation have less pain and need fewer opioids.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Weill Medical Coll of Cornell Univ NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project ID | NIH-11184267 on NIH RePORTER |
What this research studies
If your child is a baby or child who needs a breathing machine for acute respiratory failure, doctors at participating pediatric intensive care units may enroll them in this randomized, double-blind, placebo-controlled trial. Around 644 children across 14 PICUs will be randomly assigned to one of four treatment groups that compare acetaminophen, ketorolac, their combination, or placebo given alongside standard opioid care. Families and clinical teams will not know which treatment the child receives, and researchers will track pain episodes, opioid dosing, and related outcomes while the child is on mechanical ventilation. The goal is to find whether adding these non-opioid medicines reduces pain and the amount of opioids children receive.
Who could benefit from this research
Good fit: Children (infants through about age 11) with acute respiratory failure who require invasive mechanical ventilation in a participating pediatric ICU are the intended candidates for enrollment.
Not a fit: Children who are not on invasive mechanical ventilation, who have contraindications to acetaminophen or ketorolac (for example severe liver disease or bleeding risk), or who are being managed under a different analgesia protocol are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this approach could reduce painful episodes and lower opioid exposure for children on mechanical ventilation, potentially decreasing withdrawal, tolerance, and other opioid-related harms.
How similar studies have performed: There is limited randomized trial evidence in critically ill children, and while some adult or small pediatric studies suggest non-opioid adjuvants can reduce opioid needs, this large pediatric RCT is relatively novel.
Where this research is happening
New York, United States
- Weill Medical Coll of Cornell Univ — New York, United States (Active)
Researchers
- Principal investigator: Traube, Chani — Weill Medical Coll of Cornell Univ
- Study coordinator: Traube, Chani
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.