Recruiting

OPTICOMPain Management in Children on Mechanical Ventilation

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What is being tested

Acetaminophen

+ Ketorolac

+ Placebo

Drug
Who is being recruted

Agnosia+4

+ Nervous System Diseases

+ Neurologic Manifestations

From 2 Months to 17 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorWeill Medical College of Cornell University
Study ContactChani Traube, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving pain management for children who need mechanical ventilation due to severe breathing problems. Each year, many children in the United States require this kind of support, but the current methods for controlling their pain often rely on opioids. These drugs can lead to problems like addiction, withdrawal symptoms, and longer hospital stays, and they don't always relieve pain effectively. This study is important because it explores the use of intravenous acetaminophen and ketorolac as alternatives to reduce opioid use and improve pain relief for these young patients. Participants in this study are children aged 2 months to 17 years 6 months who need mechanical ventilation and opioids for pain. They are randomly placed into one of four groups to receive either intravenous acetaminophen with a placebo, intravenous ketorolac with a placebo, both medications together, or both placebos. The medications are given for up to five days, while usual care with opioids and benzodiazepines continues as needed. The study will measure how well the alternative medications control pain and reduce opioid use. This involves complex statistical methods to ensure the findings are accurate and meaningful.

Official TitleOptimizing Pain Treatment in Children On Mechanical Ventilation
NCT06994442
Principal SponsorWeill Medical College of Cornell University
Study ContactChani Traube, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

644 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 Months to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaNervous System DiseasesNeurologic ManifestationsPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

4 inclusion criteria required to participate
At least 2 months of age to 17 years 6 months; AND

Acute Respiratory Failure requiring endotracheal intubation; AND

Opioid infusion planned or started; AND

Expected duration of Invasive Mechanical Ventilation > 48 hours

17 exclusion criteria prevent from participating
History of allergic-type reaction to either acetaminophen or non-steroidal anti-inflammatory (NSAID) medications; OR

Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding; OR

Expected need for continuous neuromuscular blockade for more than 24 hours following intubation; OR

Requirement for tight temperature control (defined as the requirement for continuous administration of antipyretic medications to prevent secondary injuries associated with fever); OR

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Experimental
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

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

Group IV

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Recruiting

Children's Hospital of Michigan

Detroit, United StatesOpen Children's Hospital of Michigan in Google Maps
Recruiting

Duke Children's Hospital & Health Center

Durham, United States
Recruiting

Rainbow Babies and Children's Hospital

Cleveland, United States
Recruiting

Children's Hospital of Philadelphia

Philadelphia, United States
Recruiting
15 Study Centers