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Recruiting Phase 3 Interventional

Optimizing Pain Treatment in Children On Mechanical Ventilation

ClinicalTrials.gov ID: NCT06994442

Public ClinicalTrials.gov record NCT06994442. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06994442
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
644 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Months to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 28, 2025
Primary completion
Jul 30, 2029
Completion
Aug 30, 2029
Last update posted
Jul 29, 2026

2025 – 2029

United States locations

U.S. sites
16
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 Recruiting
Children's National Hospital Washington D.C. District of Columbia 20010-2916 Recruiting
University of Michigan Ann Arbor Michigan 48109-1274 Recruiting
Children's Hospital of Michigan Detroit Michigan 48201-2119 Recruiting
University of Minnesota Minneapolis Minnesota 55454-1450 Recruiting
Duke Children's Hospital & Health Center Durham North Carolina 27705-4677 Recruiting
Rainbow Babies and Children's Hospital Cleveland Ohio 44106-4919 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205-2664 Recruiting
Penn State Health/Hershey Medical Center Hershey Pennsylvania 17033-0850 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104-4319 Recruiting
University of Pittsburgh Pittsburgh Pennsylvania 15261-0001 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
UT Southwestern Medical Center Dallas Texas 75390 Not yet recruiting
Texas Children's Hospital/Baylor College of Medicine Houston Texas 77030-3411 Not yet recruiting
Primary Children's Medical Center Salt Lake City Utah 84112-9023 Recruiting
Wisconsin Children's Milwaukee Wisconsin 53226-3548 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06994442, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 29, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06994442 live on ClinicalTrials.gov.

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