Optimizing Pain Treatment in Children On Mechanical Ventilation
OPTICOM
2 other identifiers
interventional
644
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
December 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
February 20, 2026
February 1, 2026
3.6 years
May 20, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Pain Episodes
Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score. Coma will be defined using standardized sedation scales. The number of time periods where the participant is both pain-free (FLACC \<4) and coma-free will be recorded.
First 5 days of mechanical ventilation or until extubation, whichever comes first
Secondary Outcomes (2)
Opioid Exposure
First 5 days of mechanical ventilation or until extubation, whichever comes first
Benzodiazepine Exposure
First 5 days of mechanical ventilation or until extubation, whichever comes first
Study Arms (4)
Intravenous Acetaminophen (IV-A) + Intravenous Placebo
EXPERIMENTALParticipants receive intravenous acetaminophen and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Intravenous Ketorolac (IV-K) + Intravenous Placebo
EXPERIMENTALParticipants receive intravenous ketorolac and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K)
EXPERIMENTALParticipants receive intravenous acetaminophen and intravenous ketorolac every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Intravenous Placebo + Intravenous Placebo
PLACEBO COMPARATORParticipants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
Interventions
Intravenous (IV) dose, 15 mg/kg\* (maximum 1g) every 6 h for 5 days. \*Note: The dosing of acetaminophen for intravenous infusion will follow the current Acetaminophen for injection labeling based on the participant's age and weight.
IV dose; 0.5mg/kg (maximum 15 mg) every 6 h for 5 days. \*Note: Ketorolac for intravenous bolus administration is currently labeled for multiple-dose treatment in adults. For patients under 65 years of age, the recommended dose is 30 mg every 6 hours, with a maximum daily dose of 120 mg. For patients 65 years or older, renally impaired patients, and those weighting less than 50 kg, the recommended dose is 15 mg every 6 hours, with a maximum daily dose of 60 mg. In this study, we will be limiting ketorolac to ≤15 mg per dose, with a maximum of 60 mg per day.
Placebos will be normal saline solution, i.e., 0.9% NaCl. In order to maintain blinding, the investigational pharmacy will dispense placebo in a volume to match the corresponding study drug.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Platelet count \< 100,000/microliter; OR
- 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
- 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
- Current treatment with extracorporeal therapies (e.g., ECMO, CVVH, plasma exchange); OR
- Cardiac bypass surgery within the past 24 hours prior to eligibility; OR
- Requirement for the patient to receive lithium, pentoxifylline or probenecid as part of their routine care; OR
- Unable to obtain consent and randomize within 12 hours of eligibility, OR
- Positive pregnancy test; OR
- Coma, Vegetative State, or Brain Death (Pediatric Cerebral Performance Category (PCPC) score of 5 or 6) suspected or confirmed; OR
- Cardiac arrest has occurred within 72 hours of eligibility criteria being met; OR
- Limitations in care in place at the time of eligibility, or anticipated to be considered during the 5-day study period, OR
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010-2916, United States
University of Michigan
Ann Arbor, Michigan, 48109-1274, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201-2119, United States
University of Minnesota
Minneapolis, Minnesota, 55454-1450, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705-4677, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-4919, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664, United States
Penn State Health/Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4319, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261-0001, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030-3411, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84112-9023, United States
Wisconsin Children's
Milwaukee, Wisconsin, 53226-3548, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chani Traube, MD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2025
First Posted
May 29, 2025
Study Start
December 29, 2025
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- De-identified IPD will be available no later than 12 months after publication of the primary results and for at least 5 years thereafter.
- Access Criteria
- Access will be granted to qualified researchers with a methodologically sound proposal. Researchers must agree to a data use agreement, and requests will be reviewed by the study team and the Data Coordinating Center.
De-identified individual participant data (IPD) including baseline, outcome, and adverse event data will be shared via NIH-approved repositories (e.g., HEAL KIDS Data Platform) within 12 months after publication of primary results. Access will be granted to qualified researchers with a methodologically sound proposal and appropriate agreements, for academic research, meta-analyses, and other approved studies.