Adenoidectomy, Tonsillectomy, Tranexamic Acid
Conditions
Keywords
Adenotonsillectomy, Tranexamic acid, Blood loss, Postoperative hemorrhage
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.
Interventions
DRUGTranexamic Acid
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
OTHERnormal saline solution
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
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume of intraoperative bleeding | one day | intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative bleeding | ten days | incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations |
Countries
Brazil
Outcome results
None listed