Tranexamic Acid and Pediatric Adenotonsillectomy

Phase 4

Completed

• Conditions: Tonsillectomy; Adenoidectomy; Tranexamic Acid
• Interventions: Drug: Tranexamic Acid; Other: normal saline solution

• Registration Number: NCT01228136
• Lead Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-21
• Last Update Posted: 2010-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	-
Placebo	normal saline solution	-

Primary Outcome Measures

Name	Time	Method
volume of intraoperative bleeding	one day	intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital da Criança Santo Antônio; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil