Orthopaedic Trauma study: Ketorolac Injection
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 a once-daily injectable medicine, 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 study will find out whether giving ketorolac early after injury reduces the chance of needing opioids for six months and improves how patients handle pain.
- Who it's for
- Adults who have suffered orthopedic trauma and are receiving standard pain‑management care.
- What's involved
- Participants will receive ketorolac every 6 hours for up to five days (or oral tablets if discharged early) plus usual pain meds, and will record pain and opioid use daily and complete surveys at discharge, 2 weeks, 6 weeks, 3 months and 6 months.
- Time commitment
- The trial lasts about six months with several follow‑up visits or surveys during that time.
- 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 is enrolling
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.