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Optimizing Pain Treatment in Children On Mechanical Ventilation

RecruitingPhase 3

Who can join

2 Months – 17 Years · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Weill Medical College of Cornell University · Participants: 644 · Started: Dec 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06994442

Locations in the U.S.

ArkansasArkansas Children's Hospital, Little Rock
District of ColumbiaChildren's National Hospital, Washington D.C.
MichiganUniversity of Michigan, Ann Arbor
Children's Hospital of Michigan, Detroit
MinnesotaUniversity of Minnesota, Minneapolis
North CarolinaDuke Children's Hospital & Health Center, Durham
OhioRainbow Babies and Children's Hospital, Cleveland
Nationwide Children's Hospital, Columbus
PennsylvaniaPenn State Health/Hershey Medical Center, Hershey
Children's Hospital of Philadelphia, Philadelphia
University of Pittsburgh, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TexasUT Southwestern Medical Center, Dallas (Not yet recruiting)
Texas Children's Hospital/Baylor College of Medicine, Houston (Not yet recruiting)
UtahPrimary Children's Medical Center, Salt Lake City
WisconsinWisconsin Children's, Milwaukee

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.