Optimizing Pain Treatment in Children On Mechanical Ventilation

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · May 20, 2025

Keywords

ClinConnect Summary

In this clinical trial, researchers are exploring how well non-opioid pain medications, like acetaminophen (Tylenol) and ketorolac (Toradol), can help control pain in children who are on mechanical ventilation due to severe breathing problems. Currently, opioids are often used for pain relief, but many children still experience pain even with strong doses. The goal of this study is to find out if using acetaminophen and ketorolac can provide better pain management and reduce the need for opioids.

To participate, children aged 2 months to 17 years who need to be on a ventilator for more than 48 hours and are about to start receiving opioids may be eligible. Participants will be randomly assigned to one of four groups, receiving either acetaminophen, ketorolac, a combination of both, or a placebo (a harmless substance with no medicine). This way, researchers can compare the effects of the actual medications to see if they are more effective than the placebo in managing pain. The trial is not yet recruiting participants, but it aims to improve pain treatment for children in critical care.

Gender

ALL

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 (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