OPTICOM Study: First Patient Enrolled!
The CPCCRN Optimizing Pain Treatment in Children on Mechanical Ventilation (OPTICOM) study enrolled its first participant on December 29, 2025—an exciting milestone for this national effort to improve pain management for critically ill children.
OPTICOM is a multicenter clinical trial that will enroll 644 children across ~15 pediatric intensive care units (PICUs) in the United States. The study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the NIH HEAL KIDS PAIN initiative, which aims to advance evidence-based pain management for children.
Why OPTICOM matters
Children who require invasive mechanical ventilation often need opioids and sedatives to maintain comfort and safety. However, pain can still occur, and higher opioid exposure can contribute to complications such as withdrawal and delirium. OPTICOM will test whether adding common non-opioid medications to usual care can improve pain control while reducing opioid and sedative exposure.
What the study is testing
Children ages 2 months to <18 years will be evaluated for eligibility. After parental permission is obtained, participants will be randomly assigned to one of four intravenous treatment strategies for the first five days:
1. Acetaminophen (Tylenol) + placebo
2. Ketorolac (Toradol) + placebo
3. Acetaminophen + ketorolac
4. Placebo only
Blinding and standard care
OPTICOM is a randomized, double-blind clinical trial—meaning participants, families, clinicians, and study staff do not know which study treatment is assigned during the study period. This approach helps ensure an unbiased assessment of the treatments.
Importantly, all children will continue to receive standard pain and sedation care at their hospital (including opioids and sedatives as clinically indicated), in addition to the study medication assignment.
Looking ahead
The results of OPTICOM are expected to help define best practices for treating acute pain in mechanically ventilated children in the PICU—potentially improving comfort while reducing medication-related harms.
For additional trial details, OPTICOM is registered on ClinicalTrials.gov (NCT06994442).