Using Toradol for Pain Control After Prophylactic Femoral Nailing
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
This study is testing whether adding Toradol to opioid pain relief can help patients recovering from surgery on their femur feel better while using fewer narcotics.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Louis University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT03823534 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using Toradol (ketorolac) in addition to opioids for post-operative pain management in patients undergoing prophylactic intramedullary nailing of the femur due to bone lesions. It aims to address the opioid crisis by exploring a multi-modal pain management approach that may reduce reliance on narcotics. The study will compare pain control outcomes between patients receiving both Toradol and opioids versus those receiving only opioids. The unique patient population consists of individuals without fractures, allowing for the safe use of NSAIDs post-operatively.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with femoral shaft or neck bone lesions scheduled for prophylactic intramedullary nailing.
Not a fit: Patients with concurrent pathologic fractures, significant renal impairment, or those with a history of NSAID allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management while reducing opioid consumption in post-operative patients.
How similar studies have performed: Previous studies have shown promise in multi-modal pain management strategies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Femoral Shaft or Neck bone lesion 2. 18 years old or greater 3. Plan to undergo prophylactic intramedullary nailing of one femur Exclusion Criteria: 1. Concurrent pathologic fracture 2. History of advanced renal impairment (eGFR\<30mL/min) 3. History of Peptic Ulcer Disease with bleeding or requiring hospitalization 4. History of NSAID or aspirin allergy 5. Concurrent chemotherapy regimen that prevents NSAID use 6. History of liver disease that precludes use of toradol 7. History of heart failure or cardiovascular disease that precludes toradol usage 8. Pregnancy 9. History of narcotic allergy resulting in anaphylaxis 10. Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study. 11. Patients with acetaminophen allergies resulting in anaphylaxis 12. Current use of the medication probenecid 13. Current use of the medication Pentoxifylline 14. History of aspirin induced asthma. 15. Known history of opioid dependence, abuse, or addiction. 16. Bilateral IMN of the femurs
Where this trial is running
St Louis, Missouri
- Saint Louis University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: David Greenberg, MD — St. Louis University
- Study coordinator: David Greenberg, MD
- Email: david.greenberg@health.slu.edu
- Phone: 314-617-3410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.