Mechanical VentilationPhase 3OPTICOMNCT06994442
Optimizing Pain Treatment in Children On Mechanical Ventilation
A Phase 3 study testing Acetaminophen and Ketorolac in people with Mechanical Ventilation and Pediatric Acute Respiratory Failure, run by Weill Medical College of Cornell University at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Mechanical Ventilation, Pediatric Acute Respiratory Failure, Analgesics, Opioid
- What is being tested?
- Acetaminophen and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 644 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Dec 2025to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Use of high dose NSAIDS within the prior 6 months, OR
- Suspected or confirmed cerebrovascular bleeding or hemorrhagic diathesis
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kammy Jacobsen contact
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109-1274
Erin Carlton, MD, 734-764-5302, ecarlton@umich.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
John Costello, MD, 843-792-8129, costello@musc.edu
- Recruiting
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-4919
Joseph Kohne, MD, 888-412-2454, Joseph.Kohne@uhhospitals.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
Ambrish Patel, MD, 614-722-4206, ambrish.patel@nationwidechildrens.org
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Stephanie Hsu, MD, 214-648-3111, Stephanie.Hsu@UTSouthwestern.edu
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201-2119
Kathleen Meert, MD, 313-745-5891, meert1kl@cmich.edu
- Recruiting
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705-4677
Christoph Hornik, MD, 919-668-2773, christoph.hornik@duke.edu
- Recruiting
Penn State Health/Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Neal Thomas, MD, 717-531-5337, nthomas@pennstatehealth.psu.edu
- Recruiting
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030-3411
Ayse Arikan, MD, 832-824-3827, aysea@bcm.edu
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Ronald Sanders, MD, 501-364-4166, rcsanders@uams.edu
- Recruiting
Wisconsin Children's
Milwaukee, Wisconsin, 53226-3548
Nathan Thompson, MD, 414-266-3360, nathomps@mcw.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454-1450
Joseph Resch, MD, 612-625-6678, resch066@umn.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4319
Heather Wolfe, MD, 614-440-2116, WolfeH@chop.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261-0001
Ericka Fink, MD, 412-692-6076, finkel@ccm.upmc.edu
- Recruiting
Primary Children's Medical Center
Salt Lake City, Utah, 84112-9023
Jill Sweney, MD, 801-587-7572, jill.sweney@hsc.utah.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010-2916
Sonali Basu, MD, 202-476-5923, sbasu@childrensnational.org
About this study
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.
Read the detailed description
The OPTICOM (Optimizing Pain Treatment In Children On Mechanical Ventilation) study is a multicenter, randomized, double-blind, placebo-controlled clinical trial supported by and a part of the HEAL Initiative (https://heal.nih.gov/). It is designed to improve pain management and reduce opioid exposure in critically ill children requiring invasive mechanical ventilation (MV) for acute respiratory failure (ARF).
More than 24,000 children annually in the United States require MV for ARF, yet current analgesic management relies heavily on opioids, often resulting in suboptimal pain control and significant risks including physiological dependence, withdrawal, delirium, and prolonged hospitalization. Despite the high-dose opioid use, over 90% of these children experience inadequate pain relief. There are currently no evidence-based, pediatric-specific guidelines to optimize analgesia in this population.
OPTICOM will evaluate whether the administration of intravenous acetaminophen (IV-A) and/or intravenous ketorolac (IV-K), as non-opioid adjuncts, can reduce pain and opioid exposure in this vulnerable population. A total of approximately 644 participants aged 2 months to 17 years 6 months, requiring MV and opioid infusions, will be randomized in a 1:1:1:1 ratio into one of four treatment arms: (1) IV-A + placebo, (2) IV-K + placebo, (3) IV-A + IV-K, or (4) placebo + placebo. Study drugs will be administered for a maximum of 5 days. Opioid and benzodiazepine use will continue as open-label per local standard of care.
The study employs a factorial design with stratified randomization by site. The analysis plan includes multivariable Poisson regression models to evaluate the independent and combined effects of IV-A and IV-K on primary and secondary outcomes. Sample size calculations provide >90% power to detect meaningful differences in pain control and opioid reduction.
- Conditions
- Mechanical Ventilation, Pediatric Acute Respiratory Failure, Analgesics, Opioid, Sedation and Analgesia
- Being tested
- Acetaminophen, Ketorolac, Placebo
- Keywords
- Acetaminophen, Ketorolac, Non-opioids, Acute Respiratory Failure in Children, Mechanically Ventilated Children in the ICU, Pediatric Delirium, Pain Treatment, opioids, sedation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
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.
KetorolacDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Acetaminophen (IV-A) + Intravenous Placebo | Experimental | Participants receive intravenous acetaminophen and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days. Receives: Drug: Acetaminophen; Drug: Placebo |
| Intravenous Ketorolac (IV-K) + Intravenous Placebo | Experimental | Participants receive intravenous ketorolac and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days. Receives: Drug: Ketorolac; Drug: Placebo |
| Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K) | Experimental | Participants receive intravenous acetaminophen and intravenous ketorolac every 6 hours, alongside open-label opioids per standard of care, for up to 5 days. Receives: Drug: Acetaminophen; Drug: Ketorolac |
| Intravenous Placebo + Intravenous Placebo | Placebo comparator | Participants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 5 days of mechanical ventilation or until extubation, whichever comes first
Secondary outcomes (2)
Opioid Exposure
Opioid exposure will be quantified in morphine milligram equivalents per kilogram during the first 5 days of mechanical ventilation.
Measured: First 5 days of mechanical ventilation or until extubation, whichever comes first
Benzodiazepine Exposure
Total benzodiazepine exposure (in midazolam milligram equivalents per kilogram) during the first 5 days of mechanical ventilation.
Measured: First 5 days of mechanical ventilation or until extubation, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start29 Dec 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Chani Traube, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994442
- Sponsor's protocol ID
- 24-12028276
- Other IDs
- U01HD116260
- Acronym
- OPTICOM
- Status last verified
- Oct 2026
- First submitted
- 20 May 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pain Treatment in Children On Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06994442
- Acronym / sponsor ID
- OPTICOM / 24-12028276
- Conditions
- Mechanical Ventilation, Pediatric Acute Respiratory Failure, Analgesics, Opioid, Sedation and Analgesia
- Keywords
- Acetaminophen, Ketorolac, Non-opioids, Acute Respiratory Failure in Children, Mechanically Ventilated Children in the ICU, Pediatric Delirium, Pain Treatment, opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The OPTICOM (Optimizing Pain Treatment In Children On Mechanical Ventilation) study is a multicenter, randomized, double-blind, placebo-controlled clinical trial supported by and a part of the HEAL Initiative (https://heal.nih.gov/). It is designed to improve pain management and reduce opioid exposure in critically ill children requiring invasive mechanical ventilation (MV) for acute respiratory failure (ARF).
More than 24,000 children annually in the United States require MV for ARF, yet current analgesic management relies heavily on opioids, often resulting in suboptimal pain control and significant risks including physiological dependence, withdrawal, delirium, and prolonged hospitalization. Despite the high-dose opioid use, over 90% of these children experience inadequate pain relief. There are currently no evidence-based, pediatric-specific guidelines to optimize analgesia in this population.
OPTICOM will evaluate whether the administration of intravenous acetaminophen (IV-A) and/or intravenous ketorolac (IV-K), as non-opioid adjuncts, can reduce pain and opioid exposure in this vulnerable population. A total of approximately 644 participants aged 2 months to 17 years 6 months, requiring MV and opioid infusions, will be randomized in a 1:1:1:1 ratio into one of four treatment arms: (1) IV-A + placebo, (2) IV-K + placebo, (3) IV-A + IV-K, or (4) placebo + placebo. Study drugs will be administered for a maximum of 5 days. Opioid and benzodiazepine use will continue as open-label per local standard of care.
The study employs a factorial design with stratified randomization by site. The analysis plan includes multivariable Poisson regression models to evaluate the independent and combined effects of IV-A and IV-K on primary and secondary outcomes. Sample size calculations provide >90% power to detect meaningful differences in pain control and opioid reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous Acetaminophen (IV-A) + Intravenous Placebo | Experimental | Drug: Acetaminophen, Drug: PlaceboParticipants 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 | Experimental | Drug: Ketorolac, Drug: PlaceboParticipants 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) | Experimental | Drug: Acetaminophen, Drug: KetorolacParticipants 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 comparator | Drug: PlaceboParticipants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenIntravenous (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. | Drug | Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K), Intravenous Acetaminophen (IV-A) + Intravenous Placebo |
| KetorolacIV 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. | Drug | Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K), Intravenous Ketorolac (IV-K) + Intravenous Placebo |
| PlaceboPlacebos 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. | Drug | Intravenous Acetaminophen (IV-A) + Intravenous Placebo, Intravenous Ketorolac (IV-K) + Intravenous Placebo, Intravenous Placebo + Intravenous Placebo |
Primary outcome
Acute Pain Episodes
Time frame: First 5 days of mechanical ventilation or until extubation, whichever comes first
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.
2 secondary outcomes
Opioid Exposure
Time frame: First 5 days of mechanical ventilation or until extubation, whichever comes first
Benzodiazepine Exposure
Time frame: First 5 days of mechanical ventilation or until extubation, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Mechanical Ventilation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kammy Jacobsen contact
Chani Traube, MD principal investigator
Weill Medical College of Cornell University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen and Ketorolac in people with Mechanical Ventilation and Pediatric Acute Respiratory Failure, run by Weill Medical College of Cornell University at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chani Traube, MD (212-746-3056, chr9008@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Pain Episodes (time frame: First 5 days of mechanical ventilation or until extubation, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.