NCT06994442 · Weill Medical College of Cornell University
Optimizing Pain Treatment in Children On Mechanical Ventilation
(OPTICOM)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Acute Pain Episodes
Time frame: First 5 days of mechanical ventilation or until extubation, whichever comes first
Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score. Coma will be defined using standardized sedation scales. The number of time periods where the participant is both pain-free (FLACC \<4) and coma-free will be recorded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least 2 months of age to 17 years 6 months; AND 2. Acute Respiratory Failure requiring endotracheal intubation; AND 3. Opioid infusion planned or started; AND 4. Expected duration of Invasive Mechanical Ventilation \> 48 hours
Exclusion criteria
- History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR 2. Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR 3. Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR 4. Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR 5. Platelet count \< 100,000/microliter; OR 6. Known liver disease (defined as pre-existing diagnosis of hepatic insufficiency, or a serum ALT \> 5 times upper limit
Where
- Little Rock, Arkansas
- Washington D.C., District of Columbia
- Ann Arbor, Michigan
- Detroit, Michigan
- Minneapolis, Minnesota
- Durham, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
And 3 more locations — see the full list below.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations