Actively Recruiting
Optimizing Pain Treatment in Children On Mechanical Ventilation
Led by Weill Medical College of Cornell University · Updated on 2026-02-20
644
Participants Needed
15
Research Sites
191 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing Pain Treatment in Children On Mechanical Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 months and 17 years 6 months
- Acute respiratory failure requiring endotracheal intubation
- Planned or started opioid infusion
- Expected invasive mechanical ventilation for more than 48 hours
You will not qualify if you...
- History of allergic reaction to acetaminophen or non-steroidal anti-inflammatory drugs
- Active or recent peptic ulcer disease, gastrointestinal bleeding or perforation
- Need for continuous neuromuscular blockade for more than 24 hours after intubation
- Requirement for tight temperature control using continuous antipyretics
- Platelet count below 100,000/microliter
- Known liver disease or abnormal liver tests
- Known kidney disease or high risk of renal failure
- Receiving extracorporeal therapies like ECMO or plasma exchange
- Cardiac bypass surgery within 24 hours before eligibility
- Need for lithium, pentoxifylline, or probenecid treatment
- Unable to obtain consent and randomize within 12 hours
- Positive pregnancy test
- Coma, vegetative state, or brain death (PCPC score 5 or 6)
- Cardiac arrest within 72 hours before eligibility
- Current or anticipated care limitations during the 5-day study
- Use of high-dose NSAIDs in the past 6 months
- Suspected or confirmed cerebrovascular bleeding or bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010-2916
Not Yet Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109-1274
Not Yet Recruiting
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201-2119
Actively Recruiting
5
University of Minnesota
Minneapolis, Minnesota, United States, 55454-1450
Actively Recruiting
6
Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27705-4677
Actively Recruiting
7
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-4919
Actively Recruiting
8
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2664
Actively Recruiting
9
Penn State Health/Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
10
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
11
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261-0001
Actively Recruiting
12
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
13
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030-3411
Not Yet Recruiting
14
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112-9023
Actively Recruiting
15
Wisconsin Children's
Milwaukee, Wisconsin, United States, 53226-3548
Actively Recruiting
Research Team
C
Chani Traube, MD
CONTACT
K
Kammy Jacobsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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