COMPARISON OF THE EFFICACY AND SAFETY OF TRAMADOL VERSUS TAPENTADOL IN ACUTE OSTEOARTHRITIC KNEE PAIN: A RANDOMIZED, CONTROLLED TRIAL

摘要

Objectives: Osteoarthritis of knee, a common disorder of elderly, has multifaceted pain mechanisms. Newer opioids such as tramadol and tapentadol target those multiple pain mechanisms, with few studies that compare them. We compared the efficacy and safety of tramadol versus tapentadol in acute episodes of osteoarthritic knee pain on 100 patients, 50 in each group. Methods: Group A received tramadol 50 mg twice daily for a period of 1-week, and Group B received tablet tapentadol 50 mg twice daily for a period of 1-week. Pain and function were evaluated by numerical pain rating scale (NPRS) and Western Ontario and McMaster Universities (WOMAC) questionnaire and scored during the initial baseline visit before the start of treatment. The efficacy of the drugs was evaluated at the end of 1 week follow-up by repeating the NPRS and WOMAC questionnaire. Adherence to medication was emphasized, and side effects of the drugs were evaluated by Naranjo’s scale. The data were analyzed statistically using descriptive statistics, namely, mean, standard deviation, and median. Non-parametric tests, namely, Mann–Whitney test, Wilcoxon signed rank test, and parametric tests such as unpaired t-test and paired t-test were used wherever applicable. All patients completed the study. Results: There was no statistically significant difference in the total WOMAC scoring between the two groups: Tramadol and tapentadol. However, tapentadol provided statistically significant pain relief compared to tramadol as measured by the NPRS. Both the groups tolerated the drugs well. There was no incidence of any adverse effects. Conclusion: Hence, both the drugs are efficacious in treating an acute painful episode of osteoarthritic knee pain and can be safely prescribed to the patients.