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Optimizing Pain Treatment in Children On Mechanical Ventilation

RecruitingPhase 3

Sponsor: Weill Medical College of Cornell University

Conditions: Mechanical Ventilation, Pediatric Acute Respiratory Failure, Analgesics, Opioid, Sedation and Analgesia

Interventions: Acetaminophen, Ketorolac, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 2 Months to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (16)

Little Rock, Arkansas, United States
Washington D.C., District of Columbia, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States