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Verification of the functioning and undesirable effects of the use of Tranexamic Acid (Transamin) to control bleeding in tonsill surgery

Effectiveness and adverse effcts of Tranexamic Acid use in control of bleeding inherent to Tonsillectomy surgeries with Adenoidectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9yt2g83
Enrollment
Unknown
Registered
2020-12-14
Start date
2017-09-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillectomy Bleeding

Interventions

63 children between 2 and 12 years old with an indication for tonsillectomy were recruited. Those responsible filled out a demographic data and Von Wollebrand type I questionnaire. The children were r

Sponsors

Associação Paranaense de Cultura
Lead Sponsor

Eligibility

Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Be under 12 years old; tonsillectomy indication due to recurrent infections or adenotonsillar hypertrophy.

Exclusion criteria

Exclusion criteria: Suspected von Willebrand type 1 disease; operation in the last two months; with a history of infectious processes in the last month; altered coagulogram; other coagulation disorders; use of drugs that can interfere with blood coagulation.

Design outcomes

Primary

MeasureTime frame
Clinically significant difference of twenty-five milliliters in the volume of bleeding during tonsillectomy surgery between the tranexamic acid and placebo groups.Verified by measuring the volume of blood lost during surgery in milliliters (mL) assessed through the collector's check.;When evaluating the volume in milliliters of blood lost in the procedure, no significant result was found between the use of ATX or not (p = 0.66).

Secondary

MeasureTime frame
Variation in time of surgery in minutes between tranexamic acid and placebo groups.It was evaluated by timing the surgeries.;The use of ATX did not significantly influence the duration of the surgery (p = 0.88).;Assessment of adverse effects with the use of tranexamic acid. Assessments of adverse effects were made during the operation, 8 hours after the procedure and / or at discharge. Participants and guardians were asked about possible common adverse effects of ATX such as: skin reaction, nausea, emesis, headache, diarrhea, seizure, dizziness or vertigo. The severity of possible adverse effects was assessed using the CTCAE scale.;No adverse effects were found in any of the participating patients, either in the group using tranexamic acid or in the placebo.

Countries

Brazil

Contacts

Public ContactMarco Fornazieri

Clinica Olfact

marcofornazieri@gmail.com+554330291436

Outcome results

None listed

Source: REBEC (via WHO ICTRP)