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


METHODS
Double-blind, randomized placebo-controlled trial.


METHODS
Tertiary hospital.


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


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


METHODS
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.
Division of Pediatric Otorhinolaryngology, Hospital da Criança Santo Antônio, Porto Alegre, Brazil. mariliarb@terra.com.br
Marília Ribeiro
MR
Brum
Maurício Schreiner
MS
Miura
Samantha Fernandez de
SF
Castro
Graziella Moraes
GM
Machado
Lucélia Hernandes
LH
Lima
José Faibes
JF
Lubianca Neto
D000233:Adenoidectomy; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000706:statistics & numerical data; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006488:Hemostasis, Surgical; D006801:Humans; D007275:Injections, Intravenous; D007431:Intraoperative Complications / Q000517:prevention & control; D016014:Linear Models; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control; D014068:Tonsillectomy; D014148:Tranexamic Acid / Q000627:therapeutic use*
D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid