Actively Recruiting
Optimizing Pain Treatment in Children On Mechanical Ventilation to Improve Pain Control and Reduce Opioid Use
Led by Weill Medical College of Cornell University · Updated on 2026-02-20
644
Participants Needed
15
Research Sites
4 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
Researchers are studying pain management in children with acute respiratory failure who require mechanical ventilation. Currently, opioids are commonly used but often don't fully relieve pain. This trial aims to see if adding non-opioid medications like acetaminophen and ketorolac can better control pain and reduce the need for opioids in these critically ill children. The study is a Phase 3, randomized, double-blind, placebo-controlled trial involving about 644 children aged 2 months to 17 years 6 months. Participants will be randomly assigned to one of four groups. Each group receives intravenous doses every 6 hours for up to 5 days: acetaminophen plus placebo, ketorolac plus placebo, both acetaminophen and ketorolac, or placebo only. Along with these study drugs, all children continue to receive opioids and benzodiazepines as standard care. The trial uses a factorial design to assess the individual and combined effects of the non-opioid medications. During the study, pain episodes and opioid and benzodiazepine use will be monitored for up to 5 days or until the child is taken off the ventilator, whichever comes first. Researchers will track pain levels and medication use closely to evaluate the effectiveness of the treatments. Safety and other health measures will also be observed throughout the trial, which is expected to run until August 2029.
CONDITIONS
Brief 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
- Opioid infusion planned or already started
- Expected need for invasive mechanical ventilation for more than 48 hours
You will not qualify if you...
- History of allergic reaction to acetaminophen or NSAID medications
- Active or recent peptic ulcer disease or gastrointestinal bleeding
- Expected need for continuous neuromuscular blockade for more than 24 hours after intubation
- Need for tight temperature control using continuous antipyretic medications
- Platelet count below 100,000/microliter
- Known liver disease or abnormal liver function tests
- Known kidney disease or risk of renal failure
- Current treatment with extracorporeal therapies like ECMO or plasma exchange
- Cardiac bypass surgery within 24 hours prior to eligibility
- Requirement 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 prior to eligibility
- Limitations in care during the 5-day study period
- Use of high-dose NSAIDs within the prior 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 days or until extubation, whichever comes first
Participants receive intravenous acetaminophen and/or intravenous ketorolac or placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days while mechanically ventilated.
Multiple daily infusions every 6 hours during the treatment period
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
K
Kammy Jacobsen
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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