A Phase 4 interventional study of Tranexamic Acid and normal saline solution in Tonsillectomy, Adenoidectomy and Tranexamic Acid, sponsored by Irmandade Santa Casa de Misericórdia de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2010-12-22.
Sponsored by Irmandade Santa Casa de Misericórdia de Porto Alegre · Phase 4, Interventional, and Prevention
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.
Tonsillectomy with or without adenoidectomy is the most common major surgical procedure performed in children. Although it's a relatively simple procedure, may present complications as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and 1/27.000 in the literature, with approximately 30% due to hemorrhage.
Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic surgery and menorrhagia.
Irmandade Santa Casa de Misericórdia de Porto Alegre is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Drug: Tranexamic Acid
Other: normal saline solution
10mg/Kg, IV (in the vein), first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
Also known as: Transamin, Hemoblock
normal saline solution in the same volume calculated as treatment (tranexamic acid 250mg/mL, 10mg/Kg), IV (in the vein) first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
volume of intraoperative bleeding
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
Time frame: one day
incidence of postoperative bleeding
incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations
Time frame: ten days
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Irmandade Santa Casa de Misericórdia de Porto Alegre