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IRCT20211028052900N2 IRCT 2022-05-01 Esfahan University of Medical Sciences The effect of topical tranexamic acid injection on bleeding during and after tonsillectomy in patients aged 15 to 45 years The effect of topical tranexamic acid injection on bleeding during and after tonsillectomy in patients aged 15 to 45 years 2022-04-03 anticipated 20 Complete https://irct.ir/trial/62462 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method is a simple randomization that is done by statistical software. The list of patients under study is prepared in advance, which includes 20 people. 10 people are supposed to be injected on the right side and 10 people on the left side, and in each of them placebo will be injected in the opposite side. Then, using random allocation software, 10 people are randomly placed in the right group and 10 people in the left group, Blinding description: The main surgeon is blind to assigning the study group. The assistant surgeon injects tranexamic acid into a patient's tonsil bed and injects distilled water into the opposite side, and the primary surgeon is unaware of the injection of tranexamic acid acid. The patient will not be informed of the side where the tranexamic acid was injected. 3 TONSILECTOMY. Intervention 1: Intervention group: 10 minutes before surgery, 100 mg of tranexamic acid is injected randomly into the bed of the right or left tonsil. The amount of intraoperative bleeding is calculated for each side of the tonsils (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use, which is considered the difference in weight equal to 1 cc of blood per gram. Recovery for each side of the tonsils is performed up to 24 hours after the operation by a nursing expert who was unaware of the type of intervention drug in the patient. The score is evaluated from 0 to 10. The lowest satisfaction score is zero and the highest satisfaction score is 10 (obtained for each side of the tonsils separately). The type of surgical technique performed for all patients is cold dissection and homeostasis by suture. Intervention 2: Control group: An equal volume of distilled water is injected into the opposite side of the tonsil and the amount of bleeding during the operation for each side of the tonsil (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use. Blood is considered to be calculated, and also the occurrence of bleeding in the recovery for each side of the tonsils up to 24 hours after the operation is done by a nursing expert who was unaware of the type of intervention drug in the patient. It is deducted from the volume inside the suction device. The surgeon's satisfaction is evaluated based on a score from 0 to 10, which will have the lowest satisfaction score of zero and the highest satisfaction score of 10 (which is obtained for each side of the tonsils separately). Surgery is performed for all patients with cold dissection and homeostasis by suture. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals. When: Start of access period 1 month after printing the results To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: Statistical analysis and the use of anonymous and unidentifiable documents will be possible after obtaining permission from the study researchers, provided by email. Where to obtain: It is possible to access the studies by email or by contacting the responsible researcher, Ali Badrouj. abadrooj@gmail.com 00989140814990 How to obtain: After submitting the request to the responsible researcher, he / she will consult with other researchers and after obtaining the opinions of other researchers, the applicant will be answered within 1 week. Comments:
public ali badrooj
Hezarjarib avenue
isfahan Iran (Islamic Republic of) 81746-75731 +98 31 3620 2020 abadrooj@gmail.com Esfahan University of Medical Sciences scientific ali badrooj
Hezarjarib avenue
isfahan Iran (Islamic Republic of) 81746-75731 +98 31 3620 2020 abadrooj@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 15 to 45 years old Functional class 1 and 2 15 years 45 years Both contraindication of the use of tranexamic acid for any reason, including allergies to the drug Anticoagulants consumption Hematologic disorders Uncontrolled systemic diseases Use a catheter to control bleeding during surgery Treatment - Drugs Placebo Intervention group: 10 minutes before surgery, 100 mg of tranexamic acid is injected randomly into the bed of the right or left tonsil. The amount of intraoperative bleeding is calculated for each side of the tonsils (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use, which is considered the difference in weight equal to 1 cc of blood per gram. Recovery for each side of the tonsils is performed up to 24 hours after the operation by a nursing expert who was unaware of the type of intervention drug in the patient. The score is evaluated from 0 to 10. The lowest satisfaction score is zero and the highest satisfaction score is 10 (obtained for each side of the tonsils separately). The type of surgical technique performed for all patients is cold dissection and homeostasis by suture. Control group: An equal volume of distilled water is injected into the opposite side of the tonsil and the amount of bleeding during the operation for each side of the tonsil (based on the volume of blood inside the calibrated suction and the difference in weight of blood gases before and after use. Blood is considered to be calculated, and also the occurrence of bleeding in the recovery for each side of the tonsils up to 24 hours after the operation is done by a nursing expert who was unaware of the type of intervention drug in the patient. It is deducted from the volume inside the suction device. The surgeon's satisfaction is evaluated based on a score from 0 to 10, which will have the lowest satisfaction score of zero and the highest satisfaction score of 10 (which is obtained for each side of the tonsils separately). Surgery is performed for all patients with cold dissection and homeostasis by suture. Amount of bleeding during tonsillectomy. Timepoint: 24 hour after surgery. Method of measurement: The amount of blood collected in the suction and the change in weight of the soaked gas. Surgeon satisfaction. Timepoint: after surgery. Method of measurement: Scale one to ten. Esfahan University of Medical Sciences Approved 2022-03-02 Ethics committee of Isfahan University of Medical Science Isfahan , Hezarjarib ave Isfahan Isfehan Iran (Islamic Republic of)