NCT01228136

Tranexamic Acid and Pediatric Adenotonsillectomy

Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tonsillectomy
• Adenoidectomy
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	Tranexamic 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
OTHER	normal 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

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-10-26
• Last updated: 2010-12-22

Locations

1 site across 1 country: Brazil