Comparison of the Effectiveness of Ketamine vs Morphine Sulfate vs Ketamine-Morphine Sulfate in Intertrochanteric Hip Fracture Pain Management of Patients

Comparing the effectiveness of Ketamine, Morphine sulfate and Ketamine-Morphine sulfate on pain control of intertrochanteric hip fracture patients

clinical trial, 3 intervention groups, double-blind, block randomized, phase 3 on 96 patients, Excel statistical software has been used to randomize patients.

With the high prevalence of hip fractures and the increasing trend of the elderly population, it is important to pay attention to the treatment and pain control of these patients. The study will be done in the emergency hospital of Shohada Ashayer Khorramabad. 96 patients are divided into three groups, after random allocation to the groups, they are treated with ketamine, morphine or both at the same time. A group of nurses, according to the pre-designed block sorting method, administers the drugs in 5cc syringes. They will give it to another group of nurses without informing them of the contents for injection. The pain score at the beginning and 30, 60, 90, 120 minutes after taking the drug will be evaluated on a visual analogue scale by an experienced emergency medicine specialist who does not know the type of drug prescribed.

Inclusion criteria: age over 65 years, intertrochanteric hip fracture in pelvic x-ray or CT scan Exclusion criteria: Allergy to Morphine or Ketamine, oxygen saturation less than 90%, change of consciousness

patients of the first group takes, 0.3 mg/kg of intravenous ketamine and 5 cc of normal saline (placebo) in 5 minutes, second group, 0.1 mg/kg of intravenous morphine and 5 cc of normal saline (placebo) in 5 minutes, and third group 0.15 mg /kg ketamine will be infused simultaneously with 0.1 mg/kg intravenous morphine in 5 minutes.

Pain score at the beginning and 30, 60, 90, 120 minutes after taking the medicine on the Visual analogue scale

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.

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.

Individual data of study participants can be shared after de-identification and information about the main outcome is accessible.

The period of access to the data is from the time of printing the results until 6 months later.

Researchers working in all academic and scientific institutions can access documented data.

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.

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.

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.