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Can tylenol and toradol replace opioids for ventilated kids?

NCT ID NCT06994442

Symptom relief Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests whether giving acetaminophen (Tylenol) and ketorolac (Toradol) to children on ventilators can better control pain and reduce the need for strong opioids. About 644 children aged 2 months to 17 years with acute respiratory failure will be randomly assigned to receive one of four combinations of these drugs or a placebo. The goal is to see if these common pain relievers can improve comfort and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acetaminophen and ketorolac
What this could lead to
If it works, this could provide a safer, more effective way to manage pain in ventilated children, reducing their reliance on opioids.
What could go wrong
This is a Phase 3 trial, but results may not apply to all children. The medications may not significantly reduce pain or opioid use, and side effects like allergic reactions or bleeding are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 644 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

acute respiratory failure agnosia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesics, opioid Mechanical ventilation Pediatric acute respiratory failure Sedation and analgesia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201-2119, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010-2916, United States

  • Duke Children's Hospital & Health Center

    RECRUITING

    Durham, North Carolina, 27705-4677, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205-2664, United States

  • Penn State Health/Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033-0850, United States

  • Primary Children's Medical Center

    RECRUITING

    Salt Lake City, Utah, 84112-9023, United States

  • Rainbow Babies and Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106-4919, United States

  • Texas Children's Hospital/Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030-3411, United States

  • UT Southwestern Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75390, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-1274, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55454-1450, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15261-0001, United States

  • Wisconsin Children's

    RECRUITING

    Milwaukee, Wisconsin, 53226-3548, United States

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