NCT06994442

Optimizing Pain Treatment in Children On Mechanical Ventilation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 644 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The OPTICOM (Optimizing Pain Treatment In Children On Mechanical Ventilation) study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to improve pain management and reduce opioid exposure in critically ill children requiring invasive mechanical ventilation (MV) for acute respiratory failure (ARF). More than 24,000 children annually in the United States require MV for ARF, yet current analgesic management relies heavily on opioids, often resulting in suboptimal pain control and significant risks including physiological dependence, withdrawal, delirium, and prolonged hospitalization. Despite the high-dose opioid use, over 90% of these children experience inadequate pain relief. There are currently no evidence-based, pediatric-specific guidelines to optimize analgesia in this population. OPTICOM will evaluate whether the administration of intravenous acetaminophen (IV-A) and/or intravenous ketorolac (IV-K), as non-opioid adjuncts, can reduce pain and opioid exposure in this vulnerable population. A total of approximately 644 participants aged 2 months to 17 years 6 months, requiring MV and opioid infusions, will be randomized in a 1:1:1:1 ratio into one of four treatment arms: (1) IV-A + placebo, (2) IV-K + placebo, (3) IV-A + IV-K, or (4) placebo + placebo. Study drugs will be administered for a maximum of 5 days. Opioid and benzodiazepine use will continue as open-label per local standard of care. The study employs a factorial design with stratified randomization by site. The analysis plan includes multivariable Poisson regression models to evaluate the independent and combined effects of IV-A and IV-K on primary and secondary outcomes. Sample size calculations provide \>90% power to detect meaningful differences in pain control and opioid reduction.

Conditions

• Mechanical Ventilation
• Pediatric Acute Respiratory Failure
• Analgesics, Opioid
• Sedation and Analgesia

Interventions

Type	Name	Description
DRUG	Acetaminophen	Intravenous (IV) dose, 15 mg/kg\* (maximum 1g) every 6 h for 5 days. \*Note: The dosing of acetaminophen for intravenous infusion will follow the current Acetaminophen for injection labeling based on the participant's age and weight.
DRUG	Ketorolac	IV dose; 0.5mg/kg (maximum 15 mg) every 6 h for 5 days. \*Note: Ketorolac for intravenous bolus administration is currently labeled for multiple-dose treatment in adults. For patients under 65 years of age, the recommended dose is 30 mg every 6 hours, with a maximum daily dose of 120 mg. For patients 65 years or older, renally impaired patients, and those weighting less than 50 kg, the recommended dose is 15 mg every 6 hours, with a maximum daily dose of 60 mg. In this study, we will be limiting ketorolac to ≤15 mg per dose, with a maximum of 60 mg per day.
DRUG	Placebo	Placebos will be normal saline solution, i.e., 0.9% NaCl. In order to maintain blinding, the investigational pharmacy will dispense placebo in a volume to match the corresponding study drug.

Timeline

• Start date: 2025-12-29
• Primary completion: 2029-07-31
• Completion: 2029-08-31
• First posted: 2025-05-29
• Last updated: 2026-02-20

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study