Experience in using Ketorol in osteoarthrosis patients with significant pain syndrome

Abstract

Objective - to study the clinical efficacy and tolerability of two dosage forms of Ketorol (tablets and solution for injections) versus the similar formulations of diclofenac sodium in patients with osteoarthrosis (OA) in an open-labeled randomized study. Patients and methods. The study covered 109 patients with OA (by the criteria developed by R. Altman et al.) with the knee joints being predominantly involved from 4 rheumatological centers of the Russian Federation. A study group comprised 51 female patients with gonarthrosis, treated with Ketorol (25 patients received the drug as tablets and 26 patients had it as injections) and a control group included 58 patients given diclofenac sodium (29 patients received it as tablets and 29 had it as injections). The duration of Ketorol therapy was 5 days. Both formulations for injection were used only for 2 days and then the patients were switched to tablets. Results. Ketorol was found to be superior to diclofenac in short-term effectiveness (in relieving the pain syndrome) by 25-30%. Comparison of the results of treatment in the study and control groups showed a significantly more effective relief of the pain syndrome in those who received the drug as tablets. Both Ketorol formulations reduced the severity index by 25% whereas diclofenac did only by 15-18%. The same picture was also observed when the general condition of patients was evaluated by a physician. Analysis of WOMAK index changes indicated that by the end of the study, the percent of improvement with Ketorol use was much higher for both formulations (31% for tablets and 33% for injections) than that with diclofenac (18% and 6%). Pairwise comparison showed that the efficiency of Ketorol tablets was, in physician's opinion, much higher than that of diclofenac and the effectiveness of injections was comparable. However, the mean duration of Ketorol injections was twice greater (p = 0,003) than the similar formulation of diclofenac (426,3+153,2 min versus 288,3+173,1 min). There were no side effects of Ketorol on renal and hepatic function; no occult blood loss was found. Conclusion. The short-term use of Ketorol in severe gonarthrosis-caused pains results in a more marked improvement than that of diclofenac.