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Tranexamic Acid and Pediatric Adenotonsillectomy

Tonsillectomy Clinical Trial

Official title:
Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01228136
Study type Interventional
Source Irmandade Santa Casa de Misericórdia de Porto Alegre
Contact
Status Completed
Phase Phase 4
Start date January 2010
Completion date December 2010
View Details
See also
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