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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| volume of intraoperative bleeding | intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure | one day |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative bleeding | incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations | ten days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃlia R Brum, MD | Irmandade Santa Casa de Misericórdia de Porto Alegre | Principal Investigator |
| José Faibes Lubianca Neto, MD | Irmandade Santa Casa de Misericórdia de Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Criança Santo Antônio | Porto Alegre | Rio Grande do Sul | 90035-074 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22704676 | Derived | Brum MR, Miura MS, Castro SF, Machado GM, Lima LH, Lubianca Neto JF. Tranexamic acid in adenotonsillectomy in children: a double-blind randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1401-5. doi: 10.1016/j.ijporl.2012.04.028. Epub 2012 Jun 16. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| normal saline solution | Other | 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 |
|
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |