RECRUITING

Optimizing Pain Treatment in Children On Mechanical Ventilation

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.

Conditions

Mechanical VentilationPediatric Acute Respiratory FailureAnalgesics, OpioidSedation and Analgesia
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Related Conditions:

Mechanical VentilationPediatric Acute Respiratory FailureAnalgesics, OpioidSedation and Analgesia

Study Overview

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Study Details

Study overview

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.

Optimizing Pain Treatment in Children On Mechanical Ventilation

Optimizing Pain Treatment in Children On Mechanical Ventilation

Condition
Mechanical Ventilation
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Washington D.C.

Children's National Hospital, Washington D.C., District of Columbia, United States, 20010-2916

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109-1274

Detroit

Children's Hospital of Michigan, Detroit, Michigan, United States, 48201-2119

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55454-1450

Durham

Duke Children's Hospital & Health Center, Durham, North Carolina, United States, 27705-4677

Cleveland

Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States, 44106-4919

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205-2664

Hershey

Penn State Health/Hershey Medical Center, Hershey, Pennsylvania, United States, 17033-0850

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104-4319

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

2 Months to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

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

Study Record Dates

2029-08-31