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Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
Fornazieri MA, Kubo HKL, de Farias LC, da Silva AMF, Garcia ECD, Santos Gald, Pinna FR, Voegels RL
International archives of otorhinolaryngology. 2021;25(4):e557-e562
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.
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2.
Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Shafa A, Shetabi H, Adineh-Mehr L, Bahrami K
Tzu chi medical journal. 2021;33(2):181-187
Abstract
OBJECTIVE 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. MATERIALS AND METHODS 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(2), and ETCO(2) 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. RESULTS 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 (P < 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 (P > 0.05). CONCLUSION 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.
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Topical application of tranexamic acid after adenoidectomy: a double-blind, prospective, randomized, controlled study
Albirmawy OA, Saafan ME, Shehata EM, Basuni AS, Eldaba AA
International Journal of Pediatric Otorhinolaryngology. 2013;77((7):):1139-42.
Abstract
OBJECTIVE Is to evaluate the efficacy of tranexamic acid when applied locally in children after primary isolated adenoidectomy with respect to intra-operative blood loss and post-operative bleeding. STUDY DESIGN Prospective, double-blind, randomized, controlled trial. SETTING Otolaryngology department, Tanta University and Tiba Hospitals, Egypt. PATIENTS AND METHODS Over three years, 400 children underwent primary isolated adenoidectomy followed by topical application of tranexamic acid (tranexamic acid group, 200 children) or saline (Placebo group, 200 children) with at least two weeks' follow up. Intra-operative blood loss and post-operative hemorrhage were monitored. RESULTS Both groups were almost equivalent in age and gender. The frequency of primary post-adenoidectomy hemorrhage as well as the rate of postnasal packing and blood transfusion required to manage severe bleeding were higher in placebo group. The volume of blood loss during surgery showed significant reduction in tranexamic acid group. CONCLUSION Topical application of tranexamic acid after adenoidectomy led to a significant reduction in blood loss during surgery and decreasing in the rate of post-operative bleeding as well as the need for postnasal packing and blood transfusion. Copyright 2013 Elsevier Ireland Ltd. All rights reserved.
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Effects of tranexamic acid during endoscopic sinsus surgery in children
Eldaba AA, Amr YM, Albirmawy OA
Saudi journal of anaesthesia. 2013;7((3):):229-33.
Abstract
OBJECTIVES This study was conducted to evaluate the effect of tranexamic acid (TA) on the intra-operative bleeding during the functional endoscopic sinus surgery (FESS) in children. METHODS A total of 100 children recruited to undergo FESS were randomized into two groups. Group I: Was given just after induction, intra-venous 25 mg/kg TA diluted in 10 ml of normal saline. Group II: Was given 10 ml of normal saline. Non-invasive blood pressure, heart rate, and quality of the surgical field were estimated every 15 min. Volume of bleeding and duration of the surgical procedure were recorded. RESULTS Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding, P=0006. Also, at 30 min, revealed that 10 patients in group I had minimal bleeding versus one patient in group II, P=0.004. Meanwhile, 37 patients in group I had mild bleeding versus 28 patients in group II, P=0.059. Higher number of patients in group II than in group I had moderate bleeding, P<0001. Duration of the surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001. CONCLUSION Single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical field, reduces intra-operative bleeding, and duration of surgery.
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5.
Tranexamic acid in adenotonsillectomy in children: a double-blind randomized clinical trial
Brum MR, Miura MS, Castro SF, Machado GM, Lima LH, Neto JF
International Journal of Pediatric Otorhinolaryngology. 2012;76((10):):1401-5.
Abstract
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. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.