Status:
RECRUITING
Optimizing Pain Treatment in Children On Mechanical Ventilation
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Mechanical Ventilation
Pediatric Acute Respiratory Failure
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 wit...
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 an...
Eligibility Criteria
Inclusion
- At least 2 months of age to 17 years 6 months; AND
- Acute Respiratory Failure requiring endotracheal intubation; AND
- Opioid infusion planned or started; AND
- Expected duration of Invasive Mechanical Ventilation \> 48 hours
Exclusion
- History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR
- Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR
- Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR
- Platelet count \< 100,000/microliter; OR
- Known liver disease (defined as pre-existing diagnosis of hepatic insufficiency, or a serum ALT \> 5 times upper limit of normal or serum total bilirubin \> 2 times the upper limit of normal, as defined by hospital laboratory standards); OR
- Known kidney disease (defined as pre-existing diagnosis of renal insufficiency, or an estimated creatinine clearance \< 30 mL/min/m2 obtained within the previous 24-hours prior to eligibility, or high risk of renal failure due to volume depletion); OR
- Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
- Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
- Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR
- Unable to obtain consent and randomize within 12 hours of eligibility, OR
- Positive pregnancy test; OR
- Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR
- Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
- Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
- Use of high dose NSAIDS within the prior 6 months, OR
- Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT06994442
Start Date
August 20 2025
End Date
August 31 2029
Last Update
November 14 2025
Active Locations (15)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010-2916
3
University of Michigan
Ann Arbor, Michigan, United States, 48109-1274
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201-2119