Fornazieri Marco Aurélio, Kubo Henrique Kazuo Lima, de Farias Lisandra Coneglian, da Silva Adriano Morita Fernandes, Garcia Ellen Cristine Duarte, Santos Gustavo de Alcântara Lopes Dos, Pinna Fábio de Rezende, Voegels Richard Louis
Department of Surgery, Universidade Estadual de Londrina, Londrina, PR, Brazil.
Department of Medicine, Pontifícia Universidade Católica do Paraná, Londrina, PR, Brazil.
Int Arch Otorhinolaryngol. 2021 Feb 19;25(4):e557-e562. doi: 10.1055/s-0040-1722255. eCollection 2021 Oct.
Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
腺样体扁桃体切除术（AT）中术中和术后出血是最常见且令人担忧的并发症。氨甲环酸（TXA）以其抗纤维蛋白溶解作用而闻名，已证实其在减少出血性创伤和心脏手术出血方面有益；然而，其在AT中的有效性和应用时机尚未确定。
我们旨在评估TXA在控制AT术中及术后出血方面的疗效，并评估其在儿童中可能产生的不良反应。
本随机、对照、双盲临床试验纳入了63名2至12岁的儿童。他们在手术前10分钟被随机分配接受静脉注射TXA（10mg/kg）或安慰剂。评估术中出血量、术后出血情况以及手术期间和术后8小时的不良反应。
两组之间的出血量没有差异（TXA组平均为122.7ml，安慰剂组为115.5ml，P = 0.36）。未观察到因使用TXA而导致的术中或术后不良反应。此外，所有参与者均未出现原发性或继发性术后出血。
在我们的儿科样本中，AT术前使用TXA（10mg/kg）是安全的，没有任何不良反应。在这类手术中，它并未减少儿童的出血量。未来的研究应评估更高剂量TXA的使用及其在手术前或手术期间其他时间点的给药情况。
