Better pain relief for children on breathing machines
Official title: Optimizing Pain Treatment In Children On Mechanical ventilation (OPTICOM)
Funded at Weill Medical Coll of Cornell Univ · NIH-11184267 · Data updated 2026-11-12
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 start | September 5, 2024 |
| Project end | August 31, 2029 |
| Funding year | 2025 |
| Award (this year) | $3,444,892 |
| NIH project number | 5U01HD116260-02 |
| Project ID | NIH-11184267 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
-
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
Related research
Other NIH-funded projects on the same topics.
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Advancing Acute Respiratory Infection Care for Kids on Home Ventilators
This grant aims to improve how doctors and families manage acute respiratory infections in children who rely on invasive long-term home ventilation.
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A Tablet-Based Emotion Regulation Program for Surrogate Decision-Makers of ICU Patients on Ventilation
A randomized trial tests a brief tablet program to help people who decide for ICU patients on ventilation feel less anxious and make better decisions.
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Optimizing pain relief for children on mechanical ventilation
A large, multi-site trial tests whether adding non-opioid pain medicines to standard opioid care can reduce pain and lower opioid use in children on breathing machines in PICUs.
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Role of titin in diaphragm weakness during mechanical ventilation
This grant studies how the diaphragm’s core proteins work together, especially titin and myosin, to understand why diaphragm weakness happens during mechanical ventilation.
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Time-limited trials to guide invasive ventilation decisions
A scientific team is testing how short, structured trials of life-support in ICU patients with acute respiratory failure can help patients and families choose the best path.
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How breathing machines can harm the kidneys
Doctors will look at how ventilators change kidney filtering and salt handling in people who are critically ill to help prevent kidney damage.
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.