Evaluation of the effect of local injection of tranexamic acid on bleeding during surgery in patients with cleft palate

Comparison of the effectiveness of local injection of tranexamic acid in the amount of bleeding during surgery in patients with cleft palate in two intervention and control groups referring to Hazrat Fatemeh Teaching Hospital and Moheb Kausar and Parsian Hospitals in Tehran.

The clinical trial has two control and intervention groups with parallel groups, the study will be two-sided and randomized by lottery between 24 patients and 12 patients in each group.

This study is a double-blind randomized clinical trial, the surgeon and the patients are unaware of the type of intervention. To conduct this study randomly, patients are placed in two intervention groups and control group . After obtaining informed consent from the applicant patients, for the intervention group, the drug (tranexamic acid) was prepared for the patient half an hour before the operation, topically along with normal solution. Saline, epinephrine and lidocaine are injected. For the control group, only normal saline solution, epinephrine and lidocaine are injected. This study is carried out in Hazrat Fatemeh, Moheb Kausar and Parsian hospitals.

Children between 8 to 60 months Cleft palate alone Without having diseases such as heart arrhythmia or blood sugar

Two control and intervention groups, each of which will have 12 patients. For the 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, and for the control group only normal saline solution 1 in 200,000 epinephrine and lidocaine 5 mg/kg are injected.

Duration of surgery, intraoperative bleeding, surgeon satisfaction, intraoperative side effects

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.

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.

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.

The clinical protocol and report will be accessible whenever the libraries are visited.

Referees to Hazrat Fatima Library and people who are members of the Central Library of Iran University of Medical Sciences.

In order to model the implementation method or get ideas for future studies, the documentation of this research can be used

Hazrat Fatemeh Hospital Library located in Yusuf Abad

Call Hazrat Fatimah Hospital and request to receive documents and then arrange to visit in person.