Non-Opioid Pain Medications for Children on Mechanical Ventilation

(OPTICOM Trial)

Recruiting at 14 trial locations

Overseen By Kammy Jacobsen

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Weill Medical College of Cornell University

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

644 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chani Traube, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for children with acute respiratory failure who are on mechanical ventilation. It aims to find out if non-opioid pain medications like acetaminophen or ketorolac can better manage their pain compared to opioids, which over 90% of these kids still feel despite strong doses.

Inclusion Criteria

Expected duration of Invasive Mechanical Ventilation > 48 hours

I am between 2 months and 17.5 years old.

I needed a breathing tube for severe breathing problems.

Exclusion Criteria

Requirement for tight temperature control

History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications

Platelet count < 100,000/microliter

Treatment Details

Interventions

• Acetaminophen
• Ketorolac

Trial Overview The study tests the effectiveness of intravenous acetaminophen and ketorolac versus a placebo in managing pain for ventilated children with acute respiratory failure. Participants will be randomly assigned to one of four groups to compare how well each treatment works at reducing the need for opioids.

Participant Groups

Group I: Intravenous Ketorolac (IV-K) + Intravenous Placebo Experimental Treatment 2 Interventions

Participants receive intravenous ketorolac and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.

Group II: Intravenous Acetaminophen (IV-A) + Intravenous Placebo Experimental Treatment 2 Interventions

Participants receive intravenous acetaminophen and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.

Group III: Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K) Experimental Treatment 2 Interventions

Participants receive intravenous acetaminophen and intravenous ketorolac every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.

Group IV: Intravenous Placebo + Intravenous Placebo Placebo Group 1 Intervention

Participants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+