Critical Assessment of Effectiveness and Safety of Tramadol and Evaluation of its Market in Ukraine

Introduction. The article examines the role of tramadol in chronic pain (CP) treatment, focusing on its clinical effectiveness, safety profile, and market presence in Ukraine. Given the rising concerns surrounding opioid use, this manuscript seeks to provide a comprehensive assessment of the role of such medicine as Tramadol in pain management. The research aimed to the secondary and tertiary sources of clinical effectiveness, and safety of tramadol for the management of CP, and to analyze the Ukrainian market of this pharmaceutical in the sales data provided by PharmXplorer. Materials and Methods. This review thoroughly searched clinical trials, systematic reviews, and meta-analyses in various scientific databases, including PubMed, Scopus, Web of Science, Embase, ClinicalTrials.gov, and Google Scholar. It employed keywords such as "tramadol," "CP", "effectiveness," "safety," "adverse effects," "overdose," and "abuse" to identify relevant studies. Primary data from the analytical application for pharmaceutical market players - PharmXplorer were used as marketing research materials. Logical analysis, synthesis, generalization, graphic, and statistical methods were used in the research. Results and Conclusions. This study critically analyzed the clinical effectiveness of tramadol through a comprehensive evaluation of clinical trials, systematic reviews, and meta-analyses concerning its use for CP management in oncological patients, non-cancer pain management, and pediatric practice. The conducted analysis does not demonstrate the advantage of tramadol compared to other opioids in the treatment of chronic pain in cancer patients, or chronic pain of different origins, including in pediatric practice. The safety of tramadol in clinical settings does not exceed the safety of other narcotic analgesics, and in some cases is even inferior to it. 80% of tramadol drugs on the Ukrainian pharmaceutical market are produced in Ukraine. Nevertheless, tramadol is not recommended as a first-line therapy for CP management due to its limited efficacy and safety concerns.