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Tranexamic Acid and Pediatric Adenotonsillectomy

NCT01228136 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2010-12-22

No results posted yet for this study

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.

Conditions

  • Tonsillectomy
  • Adenoidectomy
  • Tranexamic Acid

Interventions

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

Sponsors & Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    lead OTHER

Principal Investigators

  • Marília R Brum, MD · Irmandade Santa Casa de Misericórdia de Porto Alegre

  • José Faibes Lubianca Neto, MD · Irmandade Santa Casa de Misericórdia de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228136 on ClinicalTrials.gov