Tranexamic Acid and Pediatric Adenotonsillectomy

Tonsillectomy Clinical Trial

Official title:

Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228136
• Other study ID #: ISCMPA02
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2010
• Last updated: December 21, 2010
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

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

• Adenoidectomy
• Tonsillectomy
• Tranexamic Acid

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital da Criança Santo Antônio	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume of intraoperative bleeding	intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure	one day	No
Secondary	incidence of postoperative bleeding	incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations	ten days	No