BridgeMD
New treatment option for Orthopaedic Trauma
Official title Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
ClinicalTrials.gov ID: NCT06201676
What this study is testing
What is Ketorolac Injection?
Ketorolac Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for orthopaedic trauma.
Also referred to as Toradol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- Patient age \ 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
See the full eligibility criteria
- 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
- Patient age \ 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.