NCT01133639

Ketorolac Effects on Post-operative Pain and Bone Healing

Does Ketorolac Delay Bone Healing and Improve Post-operative Pain?: A Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bunion

Interventions

Type	Name	Description
DRUG	Ketorolac	30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
DRUG	Placebo	Placebo plus standard of care

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-05-31
• Last updated: 2019-08-21
• Results posted: 2018-10-17

Locations

1 site across 1 country: United States