Ketorolac Effects on Post-operative Pain and Bone Healing
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
This will be a randomized double-blind placebo-controlled clinical trial that will accept all
eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be
randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg
orally every 8 hours for five days) plus standard of care or placebo plus standard of care.
The purpose of this study is to evaluate the effects of ketorolac plus standard of care on
post-operative pain control and radiographic osseous healing. Patients will be assessed for
pain via a validated pain questionnaire and for delayed unions via a radiographic scoring
system shown to have both high inter- and intra-observer reliability by a blinded board
certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated
including adverse events and time to regular shoe gear and activities.