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

Objectives: Adenotonsillectomy 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.

Design: Double-blind, randomized placebo-controlled trial.

Setting: Tertiary hospital.

Patients: Ninety-five children of both sexes between four and twelve years old who underwent adenotonsillectomy due to adenotonsillar hyperplasia.

Interventions: Intravenous tranexamic acid in the preoperative and at the eighth and the sixteenth hours of the postoperative periods.

Main Outcome Measure: Bleeding volume was measured in milliliters (mL) at the end of the procedure, and bleeding events were registered in the following 10 postoperative days.

Results: There 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.

Conclusions: There 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.