drugset / Trial / NCT04872283

Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

NCT04872283

Phase 3 Unknown 140 enrolled Rothman Institute Orthopaedics
RandomizedParallel-groupSingle-blindTreatment

Summary

In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing. When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications. The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.

Timeline

Start
2019-05-23
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketorolac Other / unclassified 10 mg Intravenous
Comparator Aspirin Small molecule 81 mg Oral
Comparator Ketorolac Other / unclassified Intravenous
Comparator Oxycodone Other / unclassified 5 mg Oral
Comparator Oxycodone Other / unclassified 325 mg Oral

Indications

No indication recorded.