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Improving pain control for children on breathing machines

Optimizing Pain Treatment in Children On Mechanical Ventilation

Phase 3 Interventional Weill Medical College of Cornell University · NCT06994442

This trial tests whether giving IV acetaminophen and/or IV ketorolac can reduce pain and the need for opioids in children aged 2 months to 17½ years who are on mechanical ventilation for acute respiratory failure.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment644 (estimated)
Ages2 Months to 17 Years
SexAll
SponsorWeill Medical College of Cornell University Academic / other
Locations15 sites (Little Rock, Arkansas and 14 other locations)
Trial IDNCT06994442 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 2 months to 17 years 6 months who require endotracheal intubation for acute respiratory failure, have an opioid infusion planned or started, and are expected to need invasive mechanical ventilation for more than 48 hours.

Not a fit: Children with allergies to acetaminophen or NSAIDs, active gastrointestinal bleeding or significant hepatic disease, low platelets, requirements for prolonged neuromuscular blockade or tight temperature control, or those expected to be ventilated for less than 48 hours are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, children may have better pain control with reduced opioid exposure, which could lower risks like dependence, withdrawal, delirium, and longer hospital stays.

How similar studies have performed: Non-opioid adjuncts such as IV acetaminophen and ketorolac have shown some opioid-sparing benefits in surgical and adult studies, but their effectiveness in mechanically ventilated children has not been established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Little Rock, Arkansas and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mechanical VentilationPediatric Acute Respiratory FailureAnalgesics, OpioidSedation and AnalgesiaAcetaminophenKetorolacNon-opioidsAcute Respiratory Failure in Children
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.