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IRCT20230424057979N1 IRCT 2023-05-01 Iran University of Medical Sciences Evaluation of the effect of local injection of tranexamic acid on bleeding during surgery Evaluation of the effect of local injection of tranexamic acid on bleeding during surgery in patients with cleft palate 2023-05-05 anticipated 24 Complete https://irct.ir/trial/69749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To conduct this study randomly, patients are placed in two intervention groups (12 people) and control group (12 people). The randomization in this study is such that we have a 24 envelope of two letters A (12 pieces) and B (12 pieces), where the letter A represents the intervention group and the letter B represents the control group (without tranexamic acid). which is taken out of a paper envelope for each patient before the surgery, and according to the words on it, they will be assigned to one of the two groups and will be operated on. The assistant or the person who opens the envelope will prepare the tranexamic acid solution when the surgeon is not present before the operation and it will be used by the surgeon during the operation, Blinding description: Patients and surgeons are unaware of the use of tranexamic acid. The method of blinding the surgeon is that the surgical assistant or anesthesiologist fills a syringe with this substance before the surgeon enters the operating room and injects it locally as an anesthetic with normal saline before the operation, and the surgeon injects the substance The inside of the syringe is uninformed. N/A Cleft Palate. Intervention 1: Intervention group: the prepared medicine (10 mg/kg tranexamic acid) is injected locally to the patient half an hour before the operation along with 1 normal saline solution in 200,000 epinephrine and 5 mg/kg lidocaine. Intervention 2: Control group: only normal saline solution 1 in 200,000 epinephrine and lidocaine 5 mg/kg are injected. Yes - There is a plan to make this available What will be shared: The data of the participants, the study protocol and its clinical report can be presented to the referents in the form of a thesis bound in the central library of the University of Medical Sciences and the library of Hazrat Fatemeh Hospital. When: The clinical protocol and report will be accessible whenever the libraries are visited. To whom: Referees to Hazrat Fatima Library and people who are members of the Central Library of Iran University of Medical Sciences. Conditions: In order to model the implementation method or get ideas for future studies, the documentation of this research can be used Where to obtain: Hazrat Fatemeh Hospital Library located in Yusuf Abad How to obtain: Call Hazrat Fatimah Hospital and request to receive documents and then arrange to visit in person. Comments:
public Mahdi Karami
Hazrate Fatemeh Hospital, Seyed Jamalodin AsadAbadi St.
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 dr.m.karami@gmail.com Iran University of Medical Sciences scientific Abbas Kazemi Ashtiani
Hazrate Fatemeh Hospital, Seyed Jamalodin AsadAbadi St.
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 akazemia2003@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Children between 8 to 60 months Cleft Palate 8 months 60 months Both Cleft Lip Q35 Cleft palate Treatment - Drugs Treatment - Drugs Intervention group: the prepared medicine (10 mg/kg tranexamic acid) is injected locally to the patient half an hour before the operation along with 1 normal saline solution in 200,000 epinephrine and 5 mg/kg lidocaine. Control group: only normal saline solution 1 in 200,000 epinephrine and lidocaine 5 mg/kg are injected The amount of bleeding during surgery. Timepoint: During surgery. Method of measurement: Quantitative criterion (the result of the difference in the weight of the accumulations of the suction glasses and the volume of the solution used for washing) and cumulative bleeding in gas pellets (the result of the difference in the weight of blood gases from the weight of the same amount of dry gas) and the qualitative Boezaart criterion. Surgeon satisfaction. Timepoint: After Surgery. Method of measurement: By Likert scale. Hazrate Fatemeh Hospital Approved 2023-04-19 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)