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

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: 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 randomly divided between the Transamin group or the placebo group. The Transamin group used tranexamic acid (Transamin® 10 mg / kg bolus), and the placebo group (same amount of saline) before anesthetic induction (10 minutes before the start of the tonsillectomy surgical procedure). The medication was prepared and applied by the hospital anesthetist intravenously. The surgery to remove the palatine tonsils with adenoidectomy was performed in a standardized manner, and by a single surgeon, with timed surgery time from the beginning of the surgical incision until the end of the procedure. The data were obtained from the medical record and from the analysis of the blood volume in milliliters in the intraoperative disposal container, disregarding the value of saline if used to wash the cavities in a careful and quantified manner. D02.241.223.268.860 E04.580.848 CONDITION: E04.580.848 Tonsillectomy Bleeding PRIMARY OUTCOME: 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 OUTCOME: 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. The use of ATX did not significantly influence the duration of the surgery (p = 0.88). Variation in time of surgery in minutes between tranexamic acid and placebo groups.It was evaluated by timing the surgeries. INCLUSION CRITERIA: Be under 12 years old; tonsillectomy indication due to recurrent infections or adenotonsillar hypertrophy.
Epistemonikos ID: 3546243e0deb035061932de22915b46742b7c21c
First added on: Aug 24, 2024