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New treatment option for Bone Metastases
Official title Post-Op Pain Control for Prophylactic Intramedullary Nailing.
ClinicalTrials.gov ID: NCT03823534
What this study is testing
What is Ketorolac?
Ketorolac is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bone metastases.
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
- Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Femoral Shaft or Neck bone lesion
- 18 years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
You likely can't join if
- Concurrent pathologic fracture
- History of advanced renal impairment (eGFR\<30mL/min)
- History of Peptic Ulcer Disease with bleeding or requiring hospitalization
- History of NSAID or aspirin allergy
- Concurrent chemotherapy regimen that prevents NSAID use
- History of liver disease that precludes use of toradol
See the full eligibility criteria
- Femoral Shaft or Neck bone lesion
- 18 years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
- Concurrent pathologic fracture
- History of advanced renal impairment (eGFR\<30mL/min)
- History of Peptic Ulcer Disease with bleeding or requiring hospitalization
- History of NSAID or aspirin allergy
- Concurrent chemotherapy regimen that prevents NSAID use
- History of liver disease that precludes use of toradol
- History of heart failure or cardiovascular disease that precludes toradol usage
- Pregnancy
- History of narcotic allergy resulting in anaphylaxis
- Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
- Patients with acetaminophen allergies resulting in anaphylaxis
- Current use of the medication probenecid
- Current use of the medication Pentoxifylline
- History of aspirin induced asthma.
- Known history of opioid dependence, abuse, or addiction.
- Bilateral IMN of the femurs
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, 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.