Tranexamic Acid and Pediatric Adenotonsillectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.

Detailed Description
-----------------
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.

Official Title
-----------------
Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

Conditions
-----------------
Tonsillectomy, Adenoidectomy, Tranexamic Acid

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Other: normal saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with 4 to 12 years adenotonsillar hypertrophy indication of adenotonsillectomy Exclusion Criteria: patients with blood dyscrasia patients with history of bleeding of difficult control or spontaneous hematoma patients with coagulation tests altered patients with evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or auto immune disease

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br> | Drug: Tranexamic Acid<br>* 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<br>* Other names: Hemoblock;|
| Placebo Comparator: Placebo<br> | Other: normal saline solution<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenotonsillectomy, Tranexamic acid, Blood loss, Postoperative hemorrhage