drugset / Trial / NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

NCT03823534

Phase 3 Recruiting 60 enrolled St. Louis University
RandomizedParallel-groupDouble-blindTreatment

Summary

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. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Timeline

Start
2019-02-20
Primary completion
2026-12-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 15 mg Intravenous
Subject Ketorolac Other / unclassified 30 mg Intravenous
Background Acetaminophen Small molecule 325 mg Oral
Background Acetaminophen Small molecule 500 mg Oral
Background Hydrocodone Unknown 5 mg
Background Morphine Other / unclassified Intravenous
Background Oxycodone Other / unclassified 5 mg