Prevalencia y factores asociados a eventos adversos por dipirona y tramadol intravenoso en pacientes hospitalizados de ortopedia: estudio transversal analítico en un hospital de Medellín 2010-2020

Introduction: dipyrone and tramadol are analgesics frequently used in orthopedic hospitalization, the first was withdrawn from the market in some countries due to reports of adverse events such as agranulocytosis, and the second has been related to anaphylaxis and respiratory depression. Objectives: to establish the prevalence and factors associated with adverse events due to intravenous dipyrone and tramadol in patients hospitalized in the orthopedic service of a hospital in Medellín during the years 2010 to 2020; these data were collected and analyzed according to the clinical histories of each patient. Methodology: analytical cross-sectional study of secondary source of 973 records, 253 with adverse reactions and 720 without adverse reaction. Results: the prevalence of adverse reactions was 17.47% for dipyrone and 8.53% for tramadol, finding a 95% CI for the difference between the proportion of adverse reactions for dipyrone less tramadol of (5.90% - 12,00%). 3.16% serious reactions occurred, 3.53% for dipyrone and 2.41% for tramadol, with 2.94% for dipyrone and 2.41% for tramadol being avoidable. Factors associated with overall adverse reactions were duration of use of tramadol more than 7 days (OR=5.71; IC95%:3.96–8.24) and diagnoses of infection (OR=1.96; IC95%:1.15–3.15), radiculopathy (OR=2.16; IC95%:1.19–3.92) and trauma (OR=3.43; IC95%:1.64–7.19). Conclusions: It is necessary to reinforce active pharmacovigilance to identify adverse events and associated risk factors. It is recommended to design protocols and clinical practice guidelines for the use of intravenous dipyrone and tramadol in in-hospital orthopedic services.