Shafa Amir, Shetabi Hamidreza, Adineh-Mehr Lili, Bahrami Keivan
Department of Anesthesiology, Anesthesiology and Critical Care Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Anesthesiology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Tzu Chi Med J. 2020 Oct 15;33(2):181-187. doi: 10.4103/tcmj.tcmj_111_20. eCollection 2021 Apr-Jun.
The aim of the present study was to evaluate and select the optimal dosage of tranexamic acid (TXA) to reduce blood loss during cleft palate surgery in children.
This randomized double-blind clinical trial was performed on 80 children under 3 years of age that were candidates for cleft palate surgery. These children were divided into four groups as follows: the first, second, and third groups received 5, 7.5, and 10 mg/kg of TXA, respectively. Moreover, the fourth group was considered as the control group. Before induction of anesthesia and then every 15 min during the surgery, some parameters such as mean arterial pressure, heart rate, SpO, and ETCO were recorded. Moreover, the amount of blood loss during the surgery, the level of surgeon's satisfaction, and incidence rate of complications were assessed and recorded.
The amount of blood loss during the surgery in TXA groups receiving dosages of 5, 7.5, and 10 mg/kg with the means of 63.75 ± 10.62, 61.25 ± 15.03, and 61.00 ± 14.29, respectively, was significantly lower than that of the control group with the mean of 92.25 ± 19.83 ( < 0.001). Moreover, no significant difference was found between the three groups receiving TXA dosages in terms of the amount of blood loss, the level of surgeon's satisfaction ( > 0.05).
According to the results of the present study, all three dosages of TXA had a significant role in reducing blood loss in cleft palate surgery. Given the potential for increased risk of side effects from the drug, it seems safe to use the minimal dosage of this drug to control and reduce blood loss during cleft palate surgery in children <3 years of age.
本研究旨在评估并选择氨甲环酸（TXA）的最佳剂量，以减少小儿腭裂手术中的出血量。
本随机双盲临床试验对80名3岁以下拟行腭裂手术的儿童进行。这些儿童被分为四组：第一组、第二组和第三组分别接受5、7.5和10mg/kg的TXA。此外，第四组被视为对照组。在麻醉诱导前以及手术期间每隔15分钟，记录一些参数，如平均动脉压、心率、SpO和ETCO。此外，评估并记录手术中的出血量、外科医生的满意度水平以及并发症发生率。
接受5、7.5和10mg/kg剂量TXA的组在手术中的出血量分别为63.75±10.62、61.25±15.03和61.00±14.29，显著低于对照组的92.25±19.83（<0.001）。此外，接受不同剂量TXA的三组在出血量、外科医生满意度方面无显著差异（>0.05）。
根据本研究结果，TXA的所有三种剂量在减少腭裂手术出血量方面均有显著作用。鉴于该药物有增加副作用风险的可能性，对于3岁以下小儿腭裂手术，使用该药物的最小剂量来控制和减少出血量似乎是安全的。
