Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial

Abstract

Introduction 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. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods 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. Results 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, p = 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. Conclusion 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.

The Effect of Tranexamic Acid Local Injection on Bleeding during and after Tonsillectomy: A Double-Blind Randomized Placebo-Controlled Trial

“…In our study, local TXA injection did not lead to hemodynamic complications, and no rebleeding occurred. The safety of TXA has been confirmed in previous research on various procedures and conditions 14 , 18 , 22 - 24 . Another finding of the present study was that overall surgeon satisfaction was significantly higher with TXA compared to placebo.…”

“…Contrarily, 10 mg/kg intravenous TXA did not reduce the bleeding volume in children during adenotonsillectomy 18 . In addition, Soliman et al reported no effect of 15 mg/kg intravenous TXA in decreasing tonsillectomy-related bleeding in pediatric patients 19 .…”

The Impact of Surgical Indication on Posttonsillectomy Hemorrhage: A Systematic Review and Meta‐Analysis

“…Full‐text review of these 624 articles was conducted and a total of 71 articles were selected for inclusion (Figure 1). 5,6,8,16‐82 Critical appraisal of studies indicated an acceptably low risk of bias for the majority of included studies (Figure 2A and B). Potential sources of bias were most pronounced in the blinding of participants and personnel, and outcomes in the randomized studies.…”

“…Of the studies composed of children with more than 1 indication, 10 found that indication was not related to rates of postoperative bleeding. 29,35,39,40,55,62,70,75,77,82 In 3 studies, the posttonsillectomy hemorrhage rate was higher in the CT/RT group than in the OSA/SDB group 5,6,16 ; however, 2 studies found the opposite to be true. 8 Lou et al reported significantly higher hemorrhage rates in patients with CT/RT than in those with ATH.…”