Orthopaedic TraumaPhase 4NCT06201676
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
A Phase 4 study testing Ketorolac Injection in people with Orthopaedic Trauma and Chronic Opioid Use, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopaedic Trauma, Chronic Opioid Use
- What is being tested?
- Ketorolac Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2025to 31 Aug 2027
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age: 18-70
- Patient or legally authorized representative (LAR) able to provide consent
- Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and/or intramedullary nailing)
- Anticipated hospital admission
- Patients who speak English or Spanish
- Patients who can be followed at the enrolling facility for at least 6 months
Who cannot join
- Patient age < 18 or > 70 years
- Patients with injury more than 24 hours prior to evaluation
- Patients with active hemorrhagic shock or risk of significant hemorrhage
- Patients who are pregnant or breastfeeding
- Patients with a history of active gastrointestinal bleeds or ulceration
- Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation
Show all 15Show fewer
- Patients with preexisting chronic renal, liver, heart, or lung disease
- Patients with a creatinine ≥ 1.30 mg/dL during enrollment
- Patients with history of myocardial infarction, stroke, or bleeding disorder
- Patients with head or chest injury requiring surgical intervention
- Patients with allergy to ketorolac or hypersensitivity to aspirin
- Patients receiving chronic opioid therapy or treatment for opioid use disorder
- Patients who are current IV drug users
- Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)
- Patients with insufficient follow-up or anticipated difficulty in completing follow-up at a study site for a minimum of 6 months due to any of the follow reasons: death, no follow-up after initial discharge, severe psychiatric conditions, unstable living conditions, planned follow-up at another medical center not participating in this study, live far away from the clinic, and/or incarcerated
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Arun Aneja, MD, PhD, aaneja@mgh.harvard.edu
Healy Vise, BS, hvise@mgh.harvard.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
William Obremskey, MD, william.obremskey@vumc.org
Karen M Trochez, karen.m.trochez@vumc.org
About this study
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are:
- Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone?
- Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury?
- Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?
Read more
Participants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.
Researchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.
Read the detailed description
Background: Post-traumatic pain (PTP) can be difficult to control in orthopaedic trauma patients, particularly those with multiple injuries. Currently, opioids serve as the cornerstone for pain management despite their potential for complications including chronic use. Given this, it is not surprising that new-onset opioid abuse is a leading cause of complications following orthopaedic trauma and can be a limiting factor in delaying and/or safely resuming pre-injury responsibilities. Changes in pain management are needed to help military personnel and civilians expeditiously and safely return to their pre-injury duty. Early short-term scheduled ketorolac treatment has been shown to decrease acute pain and short and mid-term opioid use but whether this translates into decreased chronic opioid use is unknown.
Hypothesis/Objective: This study attempts to determine whether an early scheduled short-term course of ketorolac treatment has a sustained impact by decreasing chronic opioid use. The study will also investigate whether this treatment improves function and resilience as well as whether early pain control and/or the functional response to pain mediate (i.e. are responsible for / explain) the effect of the ketorolac intervention on chronic opioid use.
Specific Aims:
Aim 1: Determine whether orthopaedic trauma patients who receive a scheduled five-day course of low-dose ketorolac (15 mg IV every six hours, with transition to 10 mg orally every eight hours if discharged prior to completion of the five-day regimen) in combination with standard of care (SOC) multimodal analgesia (MMA) are less likely to develop chronic opioid use, defined as continued use at six months post-injury, compared to patients receiving SOC MMA alone.
Aim 2: Determine if patients who received a consistent five-day course of low-dose ketorolac have an improved functional response to pain measured via: 1) Brief Pain Inventory (BPI), 2) Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI), and 3) Brief Resilience Scale (BRS) scores at discharge, 3 months, and 6 months post-injury. Secondary pain outcome measures such as pain VAS and MME data will also be compared between the two groups.
Aim 3: Determine (1) the extent to which early pain control during the intervention, assessed using pain VAS and MME intake, mediates the effect of ketorolac on chronic opioid use, (2) the extent to which early pain control mediates the effect of ketorolac on the functional response to pain measures, assessed using BPI, PROMIS-PI, and BRS, and (3) the extent to which early pain control and the functional response to pain in combination or isolation mediate the effect of ketorolac on chronic opioid use.
Study Design: Adult patients (aged 18 to 70 years) with an acute orthopaedic traumatic injury undergoing operative fixation and admitted at participating Level 1 trauma centers will be enrolled. Once enrolled, patient randomization will be stratified by site and NISS score categorization (either 1-15 or greater than 15). Experienced clinical research staff will prospectively identify patients with strict adherence to all inclusion and exclusion criteria. Participants will be randomized to treatment (15 mg of ketorolac IV every 6 hours for up to 5 days in combination with SOC MMA; patients discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours) or to SOC MMA alone. Measures of the functional response to pain including the BPI, PROMIS-PI, and BRS will be collected at hospital discharge and 3- and 6-months post-injury. Outcome measures of pain including VAS and MME will be recorded at enrollment, during the first five days of inpatient admission, at discharge, and at clinic follow-ups. The treatment and SOC groups will be compared using the intention-to-treat analyses across the primary and secondary outcomes. Mediation analyses will be used to understand how early pain control and the functional response to pain mediate the effect or lack of effect on chronic opioid use to better understand the factors that lead to this devastating complication.
- Conditions
- Orthopaedic Trauma, Chronic Opioid Use
- Being tested
- Ketorolac Injection, Standard of Care (SOC) Multimodal Analgesia
- Keywords
- orthopaedic trauma, chronic opioid use, NSAID, IV ketorolac, acute pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac InjectionDrug
Also called Toradol
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin Reference ID: 3281582 3 synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form. Ketorolac tromethamine possesses no sedative or anxiolytic properties.
Standard of Care (SOC) Multimodal AnalgesiaOther
Standard of care (SOC) multimodal analgesia as determined by each participating site's institutional protocol for perioperative pain management in orthopaedic trauma patients. SOC may include opioids, acetaminophen, regional anesthesia, and other non-NSAID analgesic modalities. Scheduled nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, are not permitted during the five-day perioperative treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) + Ketorolac | Experimental | The treatment arm will receive a scheduled five-day course of low-dose ketorolac in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol. Ketorolac will be administered intravenously at a dose of 15 mg every 6 hours during the perioperative period. Participants discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours. Receives: Drug: Ketorolac Injection; Other: Standard of Care (SOC) Multimodal Analgesia |
| Standard of Care (SOC) | Active comparator | The control arm will receive standard of care (SOC) multimodal analgesia according to each site's institutional protocol. Receives: Other: Standard of Care (SOC) Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Opioid Use
Defined as continued opioid use at 6 months post-trauma
Measured: 6 months
Secondary outcomes (6)
Brief Pain Inventory (BPI)
Pain assessment tool that measures both the intensity of pain and interference of pain in a patient's life, including pain relief, pain quality, and patient perception of pain. Each question is scaled from 0 to 10, with a higher score meaning worse pain.
Measured: Enrollment, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI)
NIH-validated outcome measure that assesses how pain interferes with a patient's daily activities. This is measured using a T-score metric in which 50 is the mean of a relevant reference population, and 10 is the standard deviation of the population. A higher score for this survey means a worse outcome and is representative of pain interfering more in a patient's daily activities.
Measured: Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Brief Resilience Scale (BRS)
Scale developed to assess a patient's ability to bounce back or recover from stress. This scale consists of 6 questions with answer choices ranging from 1-5. The total score is calculated and averaged to reflect the BRS score. BRS scores from 1.00 - 2.99 reflect low resilience, 3.00 - 4.30 reflect normal resilience, and scores from 4.31 - 5.00 reflect high resilience.
Measured: Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Visual Analogue Scale (VAS)
Instrument that attempts to capture a patient's perception of pain along a continuum. This will be measured on a scale of 0 - 100, with 0 being no pain, 50 being moderate pain, and 100 being the worst pain possible.
Measured: Enrollment, First Five Hospital Days, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Morphine Milligram Equivalents (MME)
Calculation used to standardize opioid consumption.
Measured: Enrollment, First Five Hospital Days, Hospital Discharge (up to 2 weeks)
Opioid Use
A survey to assess if patients are using opioids in the outpatient setting
Measured: 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start28 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic TraumaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, two-arm, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Arun Aneja, MD, PhD, Massachusetts General Hospital
- Investigators
- Arun Aneja, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201676
- Sponsor's protocol ID
- 2023P003287
- Other IDs
- HT9425-23-1-0413
- Status last verified
- May 2026
- First submitted
- 16 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
- ClinicalTrials.gov ID
- NCT06201676
- Acronym / sponsor ID
- 2023P003287
- Conditions
- Orthopaedic Trauma, Chronic Opioid Use
- Keywords
- orthopaedic trauma, chronic opioid use, NSAID, IV ketorolac, acute pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Jan 2024 (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.
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are:
- Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone?
- Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury?
- Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?
Participants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.
Researchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.
Detailed description
Background: Post-traumatic pain (PTP) can be difficult to control in orthopaedic trauma patients, particularly those with multiple injuries. Currently, opioids serve as the cornerstone for pain management despite their potential for complications including chronic use. Given this, it is not surprising that new-onset opioid abuse is a leading cause of complications following orthopaedic trauma and can be a limiting factor in delaying and/or safely resuming pre-injury responsibilities. Changes in pain management are needed to help military personnel and civilians expeditiously and safely return to their pre-injury duty. Early short-term scheduled ketorolac treatment has been shown to decrease acute pain and short and mid-term opioid use but whether this translates into decreased chronic opioid use is unknown.
Hypothesis/Objective: This study attempts to determine whether an early scheduled short-term course of ketorolac treatment has a sustained impact by decreasing chronic opioid use. The study will also investigate whether this treatment improves function and resilience as well as whether early pain control and/or the functional response to pain mediate (i.e. are responsible for / explain) the effect of the ketorolac intervention on chronic opioid use.
Specific Aims:
Aim 1: Determine whether orthopaedic trauma patients who receive a scheduled five-day course of low-dose ketorolac (15 mg IV every six hours, with transition to 10 mg orally every eight hours if discharged prior to completion of the five-day regimen) in combination with standard of care (SOC) multimodal analgesia (MMA) are less likely to develop chronic opioid use, defined as continued use at six months post-injury, compared to patients receiving SOC MMA alone.
Aim 2: Determine if patients who received a consistent five-day course of low-dose ketorolac have an improved functional response to pain measured via: 1) Brief Pain Inventory (BPI), 2) Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI), and 3) Brief Resilience Scale (BRS) scores at discharge, 3 months, and 6 months post-injury. Secondary pain outcome measures such as pain VAS and MME data will also be compared between the two groups.
Aim 3: Determine (1) the extent to which early pain control during the intervention, assessed using pain VAS and MME intake, mediates the effect of ketorolac on chronic opioid use, (2) the extent to which early pain control mediates the effect of ketorolac on the functional response to pain measures, assessed using BPI, PROMIS-PI, and BRS, and (3) the extent to which early pain control and the functional response to pain in combination or isolation mediate the effect of ketorolac on chronic opioid use.
Study Design: Adult patients (aged 18 to 70 years) with an acute orthopaedic traumatic injury undergoing operative fixation and admitted at participating Level 1 trauma centers will be enrolled. Once enrolled, patient randomization will be stratified by site and NISS score categorization (either 1-15 or greater than 15). Experienced clinical research staff will prospectively identify patients with strict adherence to all inclusion and exclusion criteria. Participants will be randomized to treatment (15 mg of ketorolac IV every 6 hours for up to 5 days in combination with SOC MMA; patients discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours) or to SOC MMA alone. Measures of the functional response to pain including the BPI, PROMIS-PI, and BRS will be collected at hospital discharge and 3- and 6-months post-injury. Outcome measures of pain including VAS and MME will be recorded at enrollment, during the first five days of inpatient admission, at discharge, and at clinic follow-ups. The treatment and SOC groups will be compared using the intention-to-treat analyses across the primary and secondary outcomes. Mediation analyses will be used to understand how early pain control and the functional response to pain mediate the effect or lack of effect on chronic opioid use to better understand the factors that lead to this devastating complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) + Ketorolac | Experimental | Drug: Ketorolac Injection, Other: Standard of Care (SOC) Multimodal AnalgesiaThe treatment arm will receive a scheduled five-day course of low-dose ketorolac in addition to standard of care (SOC) multimodal analgesia according to each site's institutional protocol. Ketorolac will be administered intravenously at a dose of 15 mg every 6 hours during the perioperative period. Participants discharged prior to completing the five-day regimen will complete the remaining treatment with oral ketorolac 10 mg every 8 hours. |
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC) Multimodal AnalgesiaThe control arm will receive standard of care (SOC) multimodal analgesia according to each site's institutional protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age: 18-70
- Patient or legally authorized representative (LAR) able to provide consent
- Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and/or intramedullary nailing)
- Anticipated hospital admission
- Patients who speak English or Spanish
Key exclusion criteria (15 listed)
- Patient age < 18 or > 70 years
- Patients with injury more than 24 hours prior to evaluation
- Patients with active hemorrhagic shock or risk of significant hemorrhage
- Patients who are pregnant or breastfeeding
- Patients with a history of active gastrointestinal bleeds or ulceration
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 |
|---|---|---|
| Ketorolac InjectionAlso: ToradolKetorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin Reference ID: 3281582 3 synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form. Ketorolac tromethamine possesses no sedative or anxiolytic properties. | Drug | Standard of Care (SOC) + Ketorolac |
| Standard of Care (SOC) Multimodal AnalgesiaStandard of care (SOC) multimodal analgesia as determined by each participating site's institutional protocol for perioperative pain management in orthopaedic trauma patients. SOC may include opioids, acetaminophen, regional anesthesia, and other non-NSAID analgesic modalities. Scheduled nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, are not permitted during the five-day perioperative treatment period. | Other | Standard of Care (SOC), Standard of Care (SOC) + Ketorolac |
Primary outcome
Chronic Opioid Use
Time frame: 6 months
Defined as continued opioid use at 6 months post-trauma
6 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: Enrollment, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI)
Time frame: Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Brief Resilience Scale (BRS)
Time frame: Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Visual Analogue Scale (VAS)
Time frame: Enrollment, First Five Hospital Days, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
Morphine Milligram Equivalents (MME)
Time frame: Enrollment, First Five Hospital Days, Hospital Discharge (up to 2 weeks)
Opioid Use
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-trauma
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 14 May 2026.
- Pilot Study ResultsLink provided by the sponsor.
- Pilot Study Results #2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Arun Aneja, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Injection in people with Orthopaedic Trauma and Chronic Opioid Use, run by Massachusetts General Hospital at 2 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 6 inclusion and 15 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Arun Aneja, MD, PhD (617-726-6546, aaneja@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Opioid Use (time frame: 6 months). 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 14 May 2026.