ABSTRACT
The non-steroidal anti-inflmmatory drugs [NSAIDs] are used as a classic treatment for painful rheumatic disorders of the knee such as osteoarthritis and rheumatoid arthritis. Ketorolac tromethamine [KT] is considered as a member of NSAIDs. It is a non-selective cycloxygenase COX inhibitor that is used in treatment of musculoskeletal and joint disorders. Because KT appears to be associated with a higher incidence of adverse effects mainly irritation to the stomach, change in kidney and liver functions, its use is restricted for the treatment of patients for whom other NSAIDs have been ineffective. The main problems associated with the frequent administration of KT could be overcome by alternative routes of administration. This could be achieved by avoiding the contact between the drug and the stomach through formulating the drug in topical formulations and this was the aim of this work. Seventy osteoarthritis patients were selected and were classified into three groups, KT group [24 patients], piroxicam group [23 patients] and placebo group [23 patients]. Efficacy assessments were done by using the Western Ontario and McMasters Individual Osteoarthritis Index [WOMAC-OA] and the WOMAC Composite Index [WOMAC-CI] for pain, stiffness, and physical functions. Tolerability assessments were done by recording any adverse effects at each visit. All adverse effects or unexpected events were recorded in the case record forms. During the study, 8 patients were lost to follow up 2 from piroxicam group, 3 from KT group and 3 from placebo group. The obtained results indicated that, there was no significant difference in efficacy between KT gel and piroxicam gel [p>0.05] in treatment symptoms of osteoarthritis patients. While there was significant difference between either KT gel or piroxicam gel and placebo gel [p<0.05]. No adverse effects were recorded in all groups within the duration of study except two patients in of KT group and one patient in placebo group showed mild skin irritation [erythema]. The clinical evaluation revealed that, therapy with topical KT in carbopol 934 gel was successful to a great extent and produced high efficacy and safety in improving patients symptoms of osteoarthritis of the knee