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NCT06994442 · ClinicalTrials.gov registry record · Phase 3

Optimizing Pain Treatment in Children On Mechanical Ventilation

A Phase 3 study of Mechanical Ventilation and Sedation and Analgesia, sponsored by Weill Medical College of Cornell University.

Recruiting
Registry status
Phase 3
Development phase
644
Enrollment target
15
Study locations

NCT06994442 is a Phase 3 study of Mechanical Ventilation and Sedation and Analgesia that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 644 participants, above the 551-participant average among 14 other Mechanical Ventilation trials with a reported enrollment target (17% higher). The trial reports 15 study locations across 11 states.

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The verdict

NCT06994442, a Phase 3 study of Mechanical Ventilation and Sedation and Analgesia, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.

RECRUITING
Registry status
Phase 3
Development phase
644 participants
Enrollment target
15
Study locations

Study Summary

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 Studied

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

Interventions

  • DRUG Placebo
  • DRUG Acetaminophen
  • DRUG Ketorolac

Study Locations (15)

Pennsylvania

  • Penn State Health/Hershey Medical Center - Hershey
  • Children's Hospital of Philadelphia - Philadelphia
  • University of Pittsburgh - Pittsburgh

Michigan

  • University of Michigan - Ann Arbor
  • Children's Hospital of Michigan - Detroit

Ohio

  • Rainbow Babies and Children's Hospital - Cleveland
  • Nationwide Children's Hospital - Columbus

Arkansas

  • Arkansas Children's Hospital - Little Rock

District of Columbia

  • Children's National Hospital - Washington D.C.

Minnesota

  • University of Minnesota - Minneapolis

North Carolina

  • Duke Children's Hospital & Health Center - Durham

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 644 participants
Start Date 2025-12-29
Est. Completion 2029-08-31
Phase Phase 3

Sponsor

Weill Medical College of Cornell University

701 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06994442

The ClinicalTrials.gov registry entry for NCT06994442 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 644 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 551-participant average among 14 other Mechanical Ventilation trials with a reported enrollment target (17% higher). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Mechanical Ventilation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06994442 reports 15 study locations spanning 11 distinct geographic areas - top geographies include Pennsylvania, Michigan, Ohio.

Frequently Asked Questions

What is clinical trial NCT06994442 about?

NCT06994442 is a clinical study titled "Optimizing Pain Treatment in Children On Mechanical Ventilation". 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 man...

What is the current status of trial NCT06994442?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2025-12-29. Estimated completion is 2029-08-31.

What conditions does trial NCT06994442 study?

This clinical trial studies the following conditions: Mechanical Ventilation, Sedation and Analgesia, Analgesics, Opioid, Pediatric Acute Respiratory Failure.

What interventions are being tested in trial NCT06994442?

The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Ketorolac (DRUG).

Who is sponsoring clinical trial NCT06994442?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06994442 being conducted?

This trial has 15 study locations across Arkansas, District of Columbia, Michigan, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.