Tranexamic acid in adenotonsillectomy in children: A double-blind randomized clinical trial

Abstract

ObjectivesAdenotonsillectomy is one of the most common surgical procedures in pediatric otolaryngology, in which bleeding is a potential complication. We evaluated the efficacy of intravenous tranexamic acid in reducing intraoperative bleeding volume, and bleeding in the following 10 postoperative days in children who underwent adenotonsillectomy. DesignDouble-blind, randomized placebo-controlled trial. SettingTertiary hospital. PatientsNinety-five children of both sexes between four and twelve years old who underwent adenotonsillectomy due to adenotonsillar hyperplasia. InterventionsIntravenous tranexamic acid in the preoperative and at the eighth and the sixteenth hours of the postoperative periods. Main outcome measureBleeding volume was measured in milliliters (mL) at the end of the procedure, and bleeding events were registered in the following 10 postoperative days. ResultsThere was no statistically significant reduction in bleeding volume with the use of tranexamic acid (mean±standard deviation, 135.13±71.44 [tranexamic acid] versus 158.21±88.09 [placebo]; P=0.195). No difference was observed in the incidence of postoperative bleeding in the 10 postoperative days, but the sample size is insufficient to exclude a type 2 error. ConclusionsThere is no benefit in the use of tranexamic acid for reducing bleeding during the transoperative period of adenotonsillectomy in children. More studies with a greater sample are required to evaluate the benefit of tranexamic acid in postoperative bleeding.