NCT06994442 Optimizing Pain Treatment in Children On Mechanical Ventilation
| NCT ID | NCT06994442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 644 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 644 participants in total. It began in 2025-12-29 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Chani Traube, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06994442 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 17 Years, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 644 participants.
Is NCT06994442 currently recruiting?
Yes, NCT06994442 is actively recruiting participants. Contact the research team at chr9008@med.cornell.edu for enrollment information.
Where is the NCT06994442 trial being conducted?
This trial is being conducted at Little Rock, United States, Washington D.C., United States, Ann Arbor, United States, Detroit, United States and 11 additional locations.
Who is sponsoring the NCT06994442 clinical trial?
NCT06994442 is sponsored by Weill Medical College of Cornell University. The principal investigator is Chani Traube, MD at Weill Medical College of Cornell University. The trial plans to enroll 644 participants.