Tranexamic Acid and Pediatric Adenotonsillectomy

Irmandade Santa Casa de Misericórdia de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Adenoidectomy; Tranexamic Acid; Tonsillectomy

Treatments: Other: normal saline solution; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01228136

ISCMPA02

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Treatment:

Other: normal saline solution