Conditions: Bunion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Placebo plus standard of care arm 2: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care

Interventions: intervention 1: Ketorolac intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care intervention 2: Placebo plus standard of care

Protocol document:
Prot_SAP_001.pdf: