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IRCT20230808059075N1 IRCT 2023-08-19 Khoram-Abad University of Medical Sciences Comparison of the Effectiveness of Ketamine vs Morphine Sulfate vs Ketamine-Morphine Sulfate in Intertrochanteric Hip Fracture Pain Management Comparison of the Effectiveness of Ketamine vs Morphine Sulfate vs Ketamine-Morphine Sulfate in Intertrochanteric Hip Fracture Pain Management of Patients 2023-08-29 anticipated 96 Complete https://irct.ir/trial/72031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning people to the studied groups is by using the block classification method. To control the effect of the confounding variable of gender, these changes are considered as classes and then in each class, people will be assigned to treatment groups using the random block method. In order to eliminate the possibility of final allocation by the person who allocates patients to groups, random block method with unequal volume is used. For this purpose, 3 of the blocks include 6 and some 9 permutations. The unit of randomization is individual and the tool used to randomize the order of entry into the study is Excel statistical software, Blinding description: Before enrolling the patient in the study, the consent form to participate in the research plan will be read to them, and if they agree, the patients will participate in the study. In the injection of drugs, a group of nurses will prepare the prescribed drugs in 5cc syringes according to the pre-designed random block method and will present them to another group of nurses who are responsible for injecting the drugs without informing them of the contents. The pain level of the patients before the drug injection and at 30, 60, 90 and 120 minutes after the end of the drug infusion will be evaluated based on the VAS scale, the responsibility of evaluating the pain score in all patients will be done by an experienced emergency medicine doctor who He does not know the type of drug prescribed, and finally, the difference in the VAS score before drug administration and the determined times after drug administration will be used as a criterion for evaluating the success of drugs in reducing pain. 3 Intertrochanteric hip fracture. Intervention 1: The first intervention group: 0.3 mg/kg of Ketamine (ROTEXMEDICA company) intravenously and 5 cc of intravenous normal saline as a placebo will be infused within 5 minutes. Intervention 2: The second intervention group: 0.1 mg/kg of intravenous Morphine (Darou Pakhsh company) and 5 cc of normal intravenous saline will be infused within 5 minutes as a placebo. Intervention 3: The third intervention group: 0.15 mg/kg of Ketamine (ROTEXMEDICA company) and 0.1 mg/kg of intravenous Morphine (Darou Pakhsh company) will be infused simultaneously within 5 minutes. Yes - There is a plan to make this available What will be shared: Individual data of study participants can be shared after de-identification and information about the main outcome is accessible. When: The period of access to the data is from the time of printing the results until 6 months later. To whom: Researchers working in all academic and scientific institutions can access documented data. Conditions: For similar research studies and data analysis, access to the documents will be provided by requesting through the academic email to the email of the research committee of Lorestan University of Medical Sciences within one week. Where to obtain: To access the data by academic email, send a request to the Vice President of Research and Technology of Lorestan University of Medical Sciences at the address research@lums.ac.ir and contact number +986633120172 or fax number +986633120173 and it will be available to you within a week. You can also contact the contact number +989166296140 and email Maark1375@gmail.com in the name of Mahdi Arkani regarding the data request. How to obtain: To access the data by academic email, send a request to the Vice President of Research and Technology of Lorestan University of Medical Sciences at the address research@lums.ac.ir and contact number +986633120172 or fax number +986633120173 and it will be available to you within a week. Comments:
public Mahdi Arkani
No 24,26 , Banafsheh Alley, Andisheh Phase 2
Borujerd Iran (Islamic Republic of) 6919757413 +98 66 4230 0652 Maark1375@gmail.com Khoram-Abad University of Medical Sciences scientific Mahdi Arkani
No 24,26 , Banafsheh Alley, Andisheh Phase 2
Borujerd Iran (Islamic Republic of) 6919757413 +98 66 4230 0652 Maark1375@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) There is evidence of femur fracture in the intertrochanteric area in the pelvic x-ray or CT scan of the patient Be over 65 years old 65 years no limit Both Patients addicted to opioids Patients with a history of allergy to Morphine or Ketamine Systolic blood pressure greater than 180 or less than 90 mm Hg Arterial oxygen saturation less than 90% Altered state of consciousness Patients who do not cooperate Patients with a history of ischemic heart diseases Patients with a history of kidney diseases Patients with a history of liver diseases Patients with a history of obstructive lung diseases Patients with a history of psychotic diseases People who have taken painkillers before entering the hospital S72.14 Intertrochanteric fracture of femur Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: 0.3 mg/kg of Ketamine (ROTEXMEDICA company) intravenously and 5 cc of intravenous normal saline as a placebo will be infused within 5 minutes. The second intervention group: 0.1 mg/kg of intravenous Morphine (Darou Pakhsh company) and 5 cc of normal intravenous saline will be infused within 5 minutes as a placebo. The third intervention group: 0.15 mg/kg of Ketamine (ROTEXMEDICA company) and 0.1 mg/kg of intravenous Morphine (Darou Pakhsh company) will be infused simultaneously within 5 minutes. Pain score on Visual analogue scale. Timepoint: The pain score of the patients at the beginning of the study and 30, 60, 90, 120 minutes after taking the medicine. Method of measurement: Visual analogue scale. Khoram-Abad University of Medical Sciences Approved 2023-08-12 Ethics Committee of Lorestan University of Medical Sciences Ethics Committee in Clinical Research, Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Khorramabad, Lorestan Khorramabad Lorestan Iran (Islamic Republic of)