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Optimizing Pain Treatment in Children On Mechanical Ventilation

Study acronym: OPTICOM
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites: 15 to 16v6
  2. Notable Start date: Aug 20, 2025 to Dec 29, 2025
    • Site details revised at 8 of 15 sites
    v5
  3. Minor Site details revised at 3 of 15 sitesv4
  4. Minor Site details revised at 1 of 15 sitesv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Aug 20, 2025
    • Site details revised at 15 of 15 sites
    • Eligibility criteria expanded, about 4 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06994442
Lead Sponsor Weill Medical College of Cornell University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Mechanical Ventilation, Pediatric Acute Respiratory Failure, Analgesics, Opioid, Sedation and Analgesia
Related terms Agnosia
Enrollment 644 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov