Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Exclusion Criteria

• •Grade 3 ankle sprain or bilateral sprain (see Appendix H)
• •Previous injury to the same ankle within 3 months prior to current injury
• •Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
• •Opioid use within 24 hours prior to study entry
• •Topical treatment, other than ice packs, applied to the painful region since time of injury
• •A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder
• •A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout
• •Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
• •A history of hypersensitivity to diclofenac or diclofenac-containing products
• •A history of intolerance to acetaminophen (rescue medication in this trial)
• •A history of skin sensitivity to adhesives (e.g. adhesive tape)
• •Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception