Pain ManagementPhase 3KETOROLAC-ICUNCT06819956
Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study
A Phase 3 study testing Ketorolac in people with Pain Management, run by University of Alberta at 1 site in Canada.
Trial summary
Opiates are commonly used to control pain in critically ill patients in the ICU. However, increased rates of opiate use in hospital may lead to increased prescription-based opiate dependence after leaving the ICU. This may contribute to the ongoing opiate epidemic across the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jun 2025to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Admission to intensive care unit (ICU)
- Participants with pain (Critical Care Pain Observation Tool [CPOT] > 1 and/or self-report pains score >1 on visual analogue scale [VAS] or numerical rating scale [NRS])
Who cannot join
- Serum Cr > 100 mmol/L for females, and >130 mmol/L for males
- Ongoing ACEi (angiotensin converting enzyme inhibitor)/ARB (angiotensin receptor blocker) use in ICU
- Known hyperkalemia > 5.5
- Pre-existing chronic kidney disease (CKD Stage > 3), defined by a serum Cr > 100 mmol/L for females, and >130 mmol/L for males (at the time of screening, based on pre-hospital stable outpatient baseline values)
- New acute kidney injury KDIGO Stage > 2 (increased more than > 2-to-3 times in serum creatinine above baseline AND/OR <0.5mL/kg/hour urine output for >12 hours)
- Pre-existing gastrointestinal bleeding (within 12 weeks of hospital admission, requiring hospitalization or medical evaluation), new peptic ulcer disease, esophagitis, esophageal varices within the last 3 months
Show all 28Show fewer
- Active gastric / duodenal / peptic ulcer, active GI bleeding
- Prior contraindications/allergies to NSAIDS or stress ulcer prophylaxis, specifically if a participant has had an anaphylactic reaction (asthma or urticaria) or non-anaphylactic asthma reaction to NSAIDs or any stress ulcer prophylaxis, e.g. proton pump inhibitor, histamine-2-blockers, etc. (e.g. proton pump inhibitor, histamine-2-blockers, etc.)
- Complete or partial syndrome of ASA-intolerance (e.g. rhinosinusitis, urticaria/angioedema, nasal polyps, asthma)
- Participants who are not receiving stress ulcer prophylaxis (e.g. proton pump inhibitor, histamine-2-blockers, etc.) while in ICU
- Any active bleeding (requiring any blood products or adjunctive coagulation agents, any output of blood >100 mL/hr, e.g. chest tube drainage, abdominal cavity drain, etc.)
- Currently receiving NSAID(s) for another indication
- Inflammatory bowel disease (e.g. participants with prior diagnosis of Crohn's disease or ulcerative colitis)
- Receiving probenecid, oxpentifylline or pentoxifylline
- Active ischemic heart disease (acute myocardial infarction, acute coronary syndrome during current hospital admission)
- Moderate-severe uncontrolled heart failure (New York Heart Association: Class II-IV)
- Moderate to severe liver impairment or active liver disease (Operational definition: participants with prior history of Child-Pugh class B (moderate) or C (severe) liver cirrhosis, OR Model for End-Stage Liver Disease-Sodium (MELD-Na) score >25, OR active acute liver failure: severe acute liver injury with encephalopathy and impaired synthetic function International Normalized Ratio (INR) >1.5 with or without pre-existing liver disease)
- Active cerebrovascular bleeding or stroke (cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax, e.g. participants with active stroke symptoms within current hospital admission)
- Cerebrovascular bleeding or other bleeding disorders
- Coagulation disorders, post-operative patients with high haemorrhagic risk or incomplete haemostasis in patients with suspected or confirmed cerebrovascular bleeding
- Neuraxial (epidural or intrathecal) administration of ketorolac tromethamine injection due to its alcohol content
- Rhabdomyolysis (creatinine kinase >5000 U/L)
- Recent transplant (during same hospital admission, e.g., heart, lung, kidney, liver, etc.)
- Known allergy to ketorolac or other NSAIDs
- Participants expected to stay in ICU < 48 hours
- In the opinion of the attending physician, expected death or withdrawal of life-sustaining treatments within 48 hours
- Participant is known to be pregnant and/or breastfeeding
- Most responsible physician, participant, or substitute decision maker declines study participation (and reason)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Vincent I Lau, MD MSc, 780-492-9390, vince.lau@ualberta.ca
About this study
Official title: Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Randomized, Blinded, Parallel-Group, Placebo-Controlled Trial to Ascertain the Effect of Ketorolac on Pain Scores and Opiate Use for Critically Ill Patients
Opiates are commonly used to control pain in critically ill patients in the ICU. However, increased rates of opiate use in hospital may lead to increased prescription-based opiate dependence after leaving the ICU. This may contribute to the ongoing opiate epidemic across the world. Other medications that can reduce pain, like non-steroidal anti-inflammatory drugs (NSAIDs), are being studied in critically ill patients. These drugs block the enzyme, cyclooxygenases (COX), which causes inflammation in the body. Blocking these enzymes can decrease pain, fever, and inflammation. Traditionally, NSAIDs are not commonly used in critically ill patients due to the perceived risk of gastrointestinal (GI) bleeding and acute kidney injury (AKI). However, many critically ill patients are already receiving medications and treatments to prevent GI bleeding and AKI and are closely monitored so these medications may be useful in reducing pain for these patients.
The purpose of this study is to see whether NSAIDs can be used safely in critically ill patients to reduce the dose of opiates required for pain control. This is a pilot study or a feasibility study, which is not expected to answer the question definitively. Its main purpose is to determine if NSAIDs could reduce the use of opiates in critically ill patients while in the ICU. The data collected in this study may be used in a larger study in the future.
Read the detailed description
Purpose: The purpose of this study is to determine the feasibility of conducting a future, adequately powered large-scale randomized trial, while evaluating the safety and efficacy of an intravenous NSAID (e.g., ketorolac) plus usual care as compared to placebo plus usual care in critically ill patients.
Hypothesis: The investigators hypothesize that this single-centre pilot study will demonstrate that NSAIDs administration is feasible and safe in ICU patients and may potentially reduce opiate use in ICU patients with pain.
Justification: Pain control in ICU is difficult to achieve given that opiates are the mainstay of analgesia in critically ill patients, but this is not without unintended side effects, especially unintended consequences of possible future drug dependence or addictions. Given that opiates and other adjunctive pain medications (e.g., acetaminophen) are being utilized at high proportional rates, and that NSAIDs are used at relatively low rates (due to the theoretical risk of increased AKI and GI bleeds), there is potential for practice change for increased NSAID use at lower doses to reduce pain and opiate use, while not increasing risks.
Objectives: The primary objective of this pilot trial is to assess the feasibility of a larger clinical trial utilizing NSAIDs in the ICU for patients with pain. The primary outcomes of the pilot feasibility trial are: recruitment and consent rates, proportion of eligible participants who are randomized vs. not randomized, retention and protocol adherence rates.
The secondary objectives are to assess safety of the proposed trial (e.g. gastrointestinal bleeding, acute kidney injury, death) and efficacy outcomes (e.g. participant pain scores, opiate and other analgesia usage).
Research Methods/Procedures: The investigators have designed KETOROLAC-ICU as a pilot randomized controlled trial (prospective, single centre, parallel-group, concealed, blinded) examining the use of low-dose ketorolac for critically ill patients.
- Conditions
- Pain Management
- Being tested
- Ketorolac, Placebo
- Keywords
- analgesia, ketorolac, NSAID, ICU
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Ketorolac 15 mg IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The ketorolac will be diluted in a 0.9% normal saline 10 mL syringe.
PlaceboDrug
Matching placebo IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The matching placebo will be diluted in a 0.9% normal saline 10 mL syringe.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | Ketorolac administration + standard of care.
Participants will not be allowed to have co-administered alternative NSAIDs during the duration of their exposure on the study drug. After each administered dose, overall analgesic requirements should be assessed by the treating team (as per local institutional guidelines and practices), with attempts to wean analgesic infusions or use reduced doses of analgesic medications (especially if objective pain score measures are zero, e.g. CPOT or NRS/VAS). Receives: Drug: Ketorolac |
| Placebo | Placebo comparator | Placebo administration + standard of care.
Participants will not be allowed to have co-administered alternative NSAIDs during the duration of their exposure on the study drug. After each administered dose, overall analgesic requirements should be assessed by the treating team (as per local institutional guidelines and practices), with attempts to wean analgesic infusions or use reduced doses of analgesic medications (especially if objective pain score measures are zero, e.g. CPOT or NRS/VAS). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment and Retention
Recruitment rate at pilot site (participants/month), consent rates of eligible participants, proportion of eligible participants not randomized, and participant retention rates.
Measured: Days 1-7, 90
Feasibility - Protocol Adherence
Rates of protocol adherence and reasons for protocol non-adherence.
Measured: Days 1-7, 90
Secondary outcomes (15)
Opioid Use
The administration of opioid medications (converted into oral morphine equivalents)
Measured: Baseline; Days 1-7, 14, 21, 28, 90
Pain Scores - Critical Care Pain Observation Tool (CPOT)
The critical care pain observation tool (CPOT) is used by healthcare workers to measure four indicators of pain: facial expression, body movements, muscle tension, and compliance with the ventilator (or vocalization for extubated participants). Each of the four indicators are ranked from 0 to 2, with higher numbers describing more pain behaviors.
Measured: Baseline; Days 1-7, 14, 21, 28
Pain Scores - Visual Analog Scale (VAS)
The visual analog scale (VAS) is a self-reported measure of a participant's level of pain. This tool consists of a single, 10cm long line, with one end titled "No pain" and the other end titled "Pain as bad as it could possibly be." The participant then draws a mark on the line that corresponds to their level of pain. This mark is later quantified in distance from the "no pain" side of the line.
Measured: Baseline; Days 1-7, 14, 21, 28
Pain Scores - Numerical Pain Rating Scale (NRS)
The numerical pain rating scale (NRS) is a self-reported measure of a participant's level of pain. Participants are asked to rank their pain on a scale of 0 to 10, with 0 representing no pain, and 10 representing the worst possible pain.
Measured: Baseline; Days 1-7, 14, 21, 28
Safety - Acute Kidney Injury
KDIGO Stage ≥ 2 (increased serum creatinine > 2-3 times above baseline AND/OR <0.5mL/kg/hour urine output for >12 hours) AND/OR need for renal replacement therapy
Measured: Days 1-7, 28
Safety - Gastrointestinal (GI) Bleeding
Clinically significant GI bleeding (visual and physiological evidence of overt GI bleeding)
Measured: Days 1-7, 28
Safety - Other
Occurrence of any adverse and/or serious adverse events
Measured: Days 1-28
All-Cause Mortality
All-cause mortality in ICU, in hospital, or post-discharge.
Measured: Days 28, 90
Health-Related Quality of Life (EQ-5D-5L)
EuroQol's Health-Related Quality of Life questionnaire (EQ-5D-5L) is a self-reported measure of a participant's current health status and quality of life. This questionnaire consists of 5 questions, each representing a different dimension of health-related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has 5 possible responses, ranging from "no problem" (score of 1) to "unable/extreme problems" (score of 5).
Measured: Day 90
Clinical Frailty Scale (CFS)
The Clinical Frailty Scale (CFS) is a tool to describe a participant's frailty and level of functioning. This scale ranges from "Very Fit" (score of 1) to "Terminally Ill" (score of 9).
Measured: Baseline; Day 90
Cognitive Measures
Delirium incidence (ICDSC scores ≥ 4), duration of decreased level of consciousness (LOC) due to moderate-severe sedation (RASS scores ≤ -3), duration of decreased LOC requiring intubation or ongoing mechanical ventilation (GCS < 8)
Measured: Days 1-28
Organ Support
Use and duration of invasive mechanical ventilation (including rates of reintubation), non-invasive ventilation, renal replacement therapy, and vasopressors
Measured: Days 1-7, 14, 21, 28, 90
Length of Admission
ICU length of stay, hospital length of stay, readmission episodes
Measured: Day 90
Procedures
Need for endoscopy (EGD or colonoscopy), angiography, and/or exploratory laparotomy
Measured: Days 1-7, 28
Other Analgesia
Administration of non-opioid analgesic medications
Measured: Days 1-7, 14, 21, 28, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start23 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent I Lau, MD MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819956
- Sponsor's protocol ID
- Pro00126948
- Acronym
- KETOROLAC-ICU
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Randomized, Blinded, Parallel-Group, Placebo-Controlled Trial to Ascertain the Effect of Ketorolac on Pain Scores and Opiate Use for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06819956
- Acronym / sponsor ID
- KETOROLAC-ICU / Pro00126948
- Conditions
- Pain Management
- Keywords
- analgesia, ketorolac, NSAID, ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Feb 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.
Opiates are commonly used to control pain in critically ill patients in the ICU. However, increased rates of opiate use in hospital may lead to increased prescription-based opiate dependence after leaving the ICU. This may contribute to the ongoing opiate epidemic across the world. Other medications that can reduce pain, like non-steroidal anti-inflammatory drugs (NSAIDs), are being studied in critically ill patients. These drugs block the enzyme, cyclooxygenases (COX), which causes inflammation in the body. Blocking these enzymes can decrease pain, fever, and inflammation. Traditionally, NSAIDs are not commonly used in critically ill patients due to the perceived risk of gastrointestinal (GI) bleeding and acute kidney injury (AKI). However, many critically ill patients are already receiving medications and treatments to prevent GI bleeding and AKI and are closely monitored so these medications may be useful in reducing pain for these patients.
The purpose of this study is to see whether NSAIDs can be used safely in critically ill patients to reduce the dose of opiates required for pain control. This is a pilot study or a feasibility study, which is not expected to answer the question definitively. Its main purpose is to determine if NSAIDs could reduce the use of opiates in critically ill patients while in the ICU. The data collected in this study may be used in a larger study in the future.
Detailed description
Purpose: The purpose of this study is to determine the feasibility of conducting a future, adequately powered large-scale randomized trial, while evaluating the safety and efficacy of an intravenous NSAID (e.g., ketorolac) plus usual care as compared to placebo plus usual care in critically ill patients.
Hypothesis: The investigators hypothesize that this single-centre pilot study will demonstrate that NSAIDs administration is feasible and safe in ICU patients and may potentially reduce opiate use in ICU patients with pain.
Justification: Pain control in ICU is difficult to achieve given that opiates are the mainstay of analgesia in critically ill patients, but this is not without unintended side effects, especially unintended consequences of possible future drug dependence or addictions. Given that opiates and other adjunctive pain medications (e.g., acetaminophen) are being utilized at high proportional rates, and that NSAIDs are used at relatively low rates (due to the theoretical risk of increased AKI and GI bleeds), there is potential for practice change for increased NSAID use at lower doses to reduce pain and opiate use, while not increasing risks.
Objectives: The primary objective of this pilot trial is to assess the feasibility of a larger clinical trial utilizing NSAIDs in the ICU for patients with pain. The primary outcomes of the pilot feasibility trial are: recruitment and consent rates, proportion of eligible participants who are randomized vs. not randomized, retention and protocol adherence rates.
The secondary objectives are to assess safety of the proposed trial (e.g. gastrointestinal bleeding, acute kidney injury, death) and efficacy outcomes (e.g. participant pain scores, opiate and other analgesia usage).
Research Methods/Procedures: The investigators have designed KETOROLAC-ICU as a pilot randomized controlled trial (prospective, single centre, parallel-group, concealed, blinded) examining the use of low-dose ketorolac for critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: KetorolacKetorolac administration + standard of care. Participants will not be allowed to have co-administered alternative NSAIDs during the duration of their exposure on the study drug. After each administered dose, overall analgesic requirements should be assessed by the treating team (as per local institutional guidelines and practices), with attempts to wean analgesic infusions or use reduced doses of analgesic medications (especially if objective pain score measures are zero, e.g. CPOT or NRS/VAS). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administration + standard of care. Participants will not be allowed to have co-administered alternative NSAIDs during the duration of their exposure on the study drug. After each administered dose, overall analgesic requirements should be assessed by the treating team (as per local institutional guidelines and practices), with attempts to wean analgesic infusions or use reduced doses of analgesic medications (especially if objective pain score measures are zero, e.g. CPOT or NRS/VAS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Admission to intensive care unit (ICU)
- Participants with pain (Critical Care Pain Observation Tool [CPOT] > 1 and/or self-report pains score >1 on visual analogue scale [VAS] or numerical rating scale [NRS])
Key exclusion criteria (28 listed)
- Serum Cr > 100 mmol/L for females, and >130 mmol/L for males
- Ongoing ACEi (angiotensin converting enzyme inhibitor)/ARB (angiotensin receptor blocker) use in ICU
- Known hyperkalemia > 5.5
- Pre-existing chronic kidney disease (CKD Stage > 3), defined by a serum Cr > 100 mmol/L for females, and >130 mmol/L for males (at the time of screening, based on pre-hospital stable outpatient baseline values)
- New acute kidney injury KDIGO Stage > 2 (increased more than > 2-to-3 times in serum creatinine above baseline AND/OR <0.5mL/kg/hour urine output for >12 hours)
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 |
|---|---|---|
| KetorolacKetorolac 15 mg IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The ketorolac will be diluted in a 0.9% normal saline 10 mL syringe. | Drug | Ketorolac |
| PlaceboMatching placebo IV q6h for a maximum of 3 days total or discharge from ICU (whichever comes first). The matching placebo will be diluted in a 0.9% normal saline 10 mL syringe. | Drug | Placebo |
Primary outcome
Feasibility - Recruitment and Retention
Time frame: Days 1-7, 90
Recruitment rate at pilot site (participants/month), consent rates of eligible participants, proportion of eligible participants not randomized, and participant retention rates.
Feasibility - Protocol Adherence
Time frame: Days 1-7, 90
Rates of protocol adherence and reasons for protocol non-adherence.
15 secondary outcomes
Opioid Use
Time frame: Baseline; Days 1-7, 14, 21, 28, 90
Pain Scores - Critical Care Pain Observation Tool (CPOT)
Time frame: Baseline; Days 1-7, 14, 21, 28
Pain Scores - Visual Analog Scale (VAS)
Time frame: Baseline; Days 1-7, 14, 21, 28
Pain Scores - Numerical Pain Rating Scale (NRS)
Time frame: Baseline; Days 1-7, 14, 21, 28
Safety - Acute Kidney Injury
Time frame: Days 1-7, 28
Safety - Gastrointestinal (GI) Bleeding
Time frame: Days 1-7, 28
Safety - Other
Time frame: Days 1-28
All-Cause Mortality
Time frame: Days 28, 90
Health-Related Quality of Life (EQ-5D-5L)
Time frame: Day 90
Clinical Frailty Scale (CFS)
Time frame: Baseline; Day 90
Cognitive Measures
Time frame: Days 1-28
Organ Support
Time frame: Days 1-7, 14, 21, 28, 90
Length of Admission
Time frame: Day 90
Procedures
Time frame: Days 1-7, 28
Other Analgesia
Time frame: Days 1-7, 14, 21, 28, 90
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 28 Sep 2026.
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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.
Vincent I Lau, MD MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac in people with Pain Management, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 28 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Vincent I Lau, MD MSc (780-492-9390, vince.lau@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment and Retention (time frame: Days 1-7, 90). The study lists 2 primary outcomes in all. 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 28 Sep 2026.