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IRCT20210923052559N3 IRCT 2023-11-22 Mashhad University of Medical Sciences Investigating the effect of tranexamic acid on tonsillectomy Investigating the effect of topical tranexamic acid in level of bleeding during and after tonsillectomy surgery 2023-12-10 anticipated 60 Complete https://irct.ir/trial/73629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done by www.randomization.com website . Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: The study subjects and those who evaluate the outcome in the participants will be unaware of the intervention and control groups due to the fact that the placebo is used in the study in parallel with the drug. 2-3 Haemorrhage due to tonsillectomy surgery. Intervention 1: Intervention group: In this group, immediately at the beginning of the tonsillectomy procedure, trangesamic acid (a 5 ml vial of trangesmic acid 100 mg/ml) will be injected at the dose of 10 mg/kg to the tonsils of the patients. In each patient, the injection in the anterior pillar will be done once in the upper, middle and lower part. Intervention 2: Control group: In the control group, normal saline (in the same vials with tranexamic acid with 5 ml volume ) will be injected into the tonsils of the patients at the beginning of the tonsillectomy procedure. The injection in the anterior pillar will be done once in the upper, middle and lower part. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We will make a decision after finishing the work and consulting with the project colleagues.
public Imaneh Roshanzamir
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2649 roshanzamiri@mums.ac.ir Mashhad University of Medical Sciences scientific Imaneh Roshanzamir
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2649 roshanzamiri@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Informed consent of the patient Patients who are candidates for tonsillectomy surgery 5 years 18 years Both Suffering from bleeding diseases The presence of tonsillar hypertrophy History of sensitivity to tranexamic acid Abnormal bleeding from the adenoid during surgery Taking drugs that may increase bleeding, such as aspirin Y60 Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care Treatment - Surgery Treatment - Surgery Intervention group: In this group, immediately at the beginning of the tonsillectomy procedure, trangesamic acid (a 5 ml vial of trangesmic acid 100 mg/ml) will be injected at the dose of 10 mg/kg to the tonsils of the patients. In each patient, the injection in the anterior pillar will be done once in the upper, middle and lower part. Control group: In the control group, normal saline (in the same vials with tranexamic acid with 5 ml volume ) will be injected into the tonsils of the patients at the beginning of the tonsillectomy procedure. The injection in the anterior pillar will be done once in the upper, middle and lower part. The amount of bleeding. Timepoint: During surgery, 24 hours and one week after surgery. Method of measurement: The amount of bleeding is calculated based on the amount of suctioned blood and gas pack. The blood volume of each small gas of 10 x 10 cm size is considered to be about 12 cc, the blood volume in the suction tube is also evaluated. Mashhad University of Medical Sciences Approved 2023-09-18 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)