Improving pain control for children on breathing machines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OPTICOM is a multicenter, randomized, double-blind, placebo-controlled, factorial Phase 3 trial testing IV acetaminophen and IV ketorolac as non-opioid adjuncts for children receiving invasive mechanical ventilation for acute respiratory failure. About 644 participants aged 2 months to 17 years 6 months will be randomized 1:1:1:1 to receive acetaminophen, ketorolac, both, or placebo for up to 5 days while routine opioid and benzodiazepine care continues per local practice. The trial measures pain control and opioid exposure to determine whether these non-opioid drugs reduce pain scores and lower total opioid use. Sites include multiple U.S. pediatric intensive care units and the study is sponsored by Weill Cornell with NICHD collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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:

1. 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 of normal or serum total bilirubin \> 2 times the upper limit of normal, as defined by hospital laboratory standards); OR
7. 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
8. Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
9. Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
10. Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR
11. Unable to obtain consent and randomize within 12 hours of eligibility, OR
12. Positive pregnancy test; OR
13. Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR
14. Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
15. Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
16. Use of high dose NSAIDS within the prior 6 months, OR
17. Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis

Where it's running

• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Children's Hospital of Michigan
  Detroit, Michigan, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Duke Children's Hospital & Health Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Chani Traube, MD — Weill Medical College of Cornell University
• Study coordinator: Chani Traube, MD
• Email: chr9008@med.cornell.edu
• Phone: 212-746-3056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.