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Ketorolac Effects on Post-operative Pain and Bone Healing

2014-08-27 03:13:20 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Bunion

Intervention

Ketorolac, Placebo

Location

Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
02215

Status

Recruiting

Source

Beth Israel Deaconess Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:20-0400

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