NIH-funded research U01 cooperative agreement

Optimizing pain relief for children on mechanical ventilation

Official title: Optimizing Pain Treatment In Children On Mechanical ventilation (OPTICOM)

Funded at Weill Medical Coll of Cornell Univ · NIH-11408555 · Data updated 2026-11-12

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.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionWeill Medical Coll of Cornell Univ
NIH-funded
Lab location1 site (New York, United States)
Project startSeptember 5, 2024
Project endAugust 31, 2029
Funding year2026
Award (this year)$3,444,765
NIH project number5U01HD116260-03
Project IDNIH-11408555 on NIH RePORTER

Who could benefit from this research

Could help

Children with acute respiratory failure requiring invasive mechanical ventilation in participating PICUs, likely within 0-11 years old.

Less likely to help

Children whose pain is already well-controlled or who have contraindications to acetaminophen or NSAIDs may derive less or no benefit.

What this research studies

This study focuses on very young patients with acute respiratory failure who require invasive mechanical ventilation. Researchers will test a protocol that combines acetaminophen and/or ketorolac with opioids to see if pain episodes decrease and opioid exposure is reduced. The trial design is a large, multi-site, double-blind, placebo-controlled randomized study enrolling 644 children across 14 pediatric ICUs. By comparing four treatment arms, the study aims to identify safer and more effective analgesia strategies during critical illness. If successful, the findings could change how pain is managed in critically ill children on ventilation.

Why it matters

Potential benefit: If successful, the approach could reduce pain and opioid exposure for children on MV, potentially lowering risks of opioid-related complications and long-term pain issues.

How similar studies have gone: Previous research suggests benefits of non-opioid adjuvants, but large, definitive trials in this population are limited; this study builds on mixed prior evidence.

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.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.