Actively Recruiting

Phase 3
Age: 2Months - 17Years
All Genders
NCT06994442

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

Age: 2Months - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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