RECRUITING

Optimizing Pain Treatment in Children On Mechanical Ventilation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Pain Treatment in Children On Mechanical Ventilation

Quick Facts

Study Start:2025-08-20
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06994442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. At least 2 months of age to 17 years 6 months; AND
  2. 2. Acute Respiratory Failure requiring endotracheal intubation; AND
  3. 3. Opioid infusion planned or started; AND
  4. 4. Expected duration of Invasive Mechanical Ventilation \> 48 hours
  1. 1. History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR
  2. 2. Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR
  3. 3. Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR
  4. 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. 5. Platelet count \< 100,000/microliter; OR
  6. 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. 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. 8. Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
  9. 9. Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
  10. 10. Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR
  11. 11. Unable to obtain consent and randomize within 12 hours of eligibility, OR
  12. 12. Positive pregnancy test; OR
  13. 13. Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR
  14. 14. Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
  15. 15. Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
  16. 16. Use of high dose NSAIDS within the prior 6 months, OR
  17. 17. Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis

Contacts and Locations

Study Contact

Chani Traube, MD
CONTACT
212-746-3056
chr9008@med.cornell.edu
Kammy Jacobsen
CONTACT
kammy.jacobsen@hsc.utah.edu

Principal Investigator

Chani Traube, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's National Hospital
Washington D.C., District of Columbia, 20010-2916
United States
University of Michigan
Ann Arbor, Michigan, 48109-1274
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201-2119
United States
University of Minnesota
Minneapolis, Minnesota, 55454-1450
United States
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705-4677
United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-4919
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
United States
Penn State Health/Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4319
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261-0001
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030-3411
United States
Primary Children's Medical Center
Salt Lake City, Utah, 84112-9023
United States
Wisconsin Children's
Milwaukee, Wisconsin, 53226-3548
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Chani Traube, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-20
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-08-20
Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

  • Acetaminophen
  • Ketorolac
  • Non-opioids
  • Acute Respiratory Failure in Children
  • Mechanically Ventilated Children in the ICU
  • Pediatric Delirium
  • Pain Treatment
  • opioids
  • sedation

Additional Relevant MeSH Terms

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