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IRCT20230804059031N1 IRCT 2023-11-26 Kashan University of Medical Sciences The Effect of Various dosage of Ketamin on postoperative pain in opiate-dependent patients undergoing orthopedic surgery The Effect of various dosages of Ketamin on postoperative pain in opiate-dependent patients undergoing radius distal, femur, and tibia fracture orthopedic surgery 2023-11-05 anticipated 50 Complete https://irct.ir/trial/72967 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning people will be the "Permuted Block Randomization" method. In this way, gradually and in the order of referral for surgery, for all three patients who will be referred, in advance by randomly selecting one of the following blocks using the table of random numbers (numbers 1 to 6) the desired sequence for the block of three The next three patients will be selected. sequence of blocks and corresponding numbers; 1) ABC 2) ACB 3) BAC 4) BCA 5) CAB 6) CBA A, 1mg/kg ketamine, B, 0.5 mg/kg ketamine C, normal saline A total of about 24 sequences will be selected. 0 (exploratory trials) Upper and lower limb fractures. Intervention 1: Intervention group 1: 1mg/kg/ ketamine/C13H16ClNO/intravenous and at the beginning of surgical incision/1 shift/made by Rotex Germany company/. Intervention 2: Intervention group 2: 0.5 mg/Ketamine/C13H16ClNO/kg/intravenous and at the beginning of surgical incision/1 shift/made by German Rotex company. Intervention 3: Intervention group3: normal saline/SODIUM CHLORIDE 0.9percent /intravenous and at the beginning of surgical incision/1 turn/manufactured by Iran Injectable and Pharmaceutical Products Company. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: There are no other conditions for the use of data or documentation Where to obtain: Ali Khandan How to obtain: After the initial review of the request, it will be sent to them within a month Comments:
public Ali Khandan
بلوار امام رضا ، نبش بلوار،جنب سوپر پروتئین کاشان
Kashan Iran (Islamic Republic of) 87159-81151 +98 913 163 2580 khandan.dr@gmail.com Kashan University of Medical Sciences scientific Ali Khandan
بلوار امام رضا ، نبش بلوار،جنب سوپر پروتئین کاشان
Kashan Iran (Islamic Republic of) 87159-81151 +98 913 163 2580 khandan.dr@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with a history of drug abuse 18-65 years 18 years 6 years Both Patients with multiple trauma Consumption of alcohol and artificial drugs not derived from opium Patients should have continuous use of drugs other than narcotics Lack of patient consent for the study Non-cooperation of the patient after entering the study History of seizures or drug sensitivity to ketamine and other contraindications to ketamine History of cardiovascular diseases Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: 1mg/kg/ ketamine/C13H16ClNO/intravenous and at the beginning of surgical incision/1 shift/made by Rotex Germany company/ Intervention group 2: 0.5 mg/Ketamine/C13H16ClNO/kg/intravenous and at the beginning of surgical incision/1 shift/made by German Rotex company Intervention group3: normal saline/SODIUM CHLORIDE 0.9percent /intravenous and at the beginning of surgical incision/1 turn/manufactured by Iran Injectable and Pharmaceutical Products Company Investigating the effectiveness of different doses of ketamine on postoperative pain in drug addicts undergoing orthopedic surgery for fractures of the distal radius, femur and tibia. Timepoint: 2, 6, 12 and 25 hours after the operation. Method of measurement: 1 to 10. Kashan Medical Sciences Approved 2022-08-21 کارگروه/ کمیته‌ اخلاق در پژوهش دانشکده پزشکی و دندانپزشکی- دانشگاه علوم پزشکی کاشان 56 Hekmat, Qutub Rawandi Boulevard, Kashan, Isfahan Province Kashan Isfehan Iran (Islamic Republic of)