Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.

Inclusion Criteria:

• Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic.
• Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications.
• Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.

Exclusion Criteria:

• Subjects who are pregnant.
• Subjects who have significant obesity.
• Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
• Subjects with active viral disease, i.e. hepatitis, HIV.