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IRCT20231005059625N1 IRCT 2023-10-25 Birjand University of Medical Sciences Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section 2023-11-22 anticipated 90 Complete https://irct.ir/trial/73064 observational Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to enter the study, the basic information of the patient is recorded in the relevant forms. The referring patients were divided into two groups A (recipients of intramuscular ketorolac) and group B (recipients of PCA pump containing morphine and Apotel) by a simple random block method and homogenization of quadruple blocks (BAAB, ABBA, BABA, ABAB, BBAA, AABB), Blinding description: In order to blind the mothers, they will be aware of the generalities of the research, which is the creation of analgesia by drugs, but they will not know about the method of prescribing drugs based on the groups under study. 15 minutes after entering the recovery room and before the intervention to create analgesia, the patient's pain is measured and recorded based on the visual pain score (VAS). Then, for the patients 6, 12 and 24 hours after the operation, the questionnaire is completed by one of the trained nurses who is not part of the research team and is not aware of the groups under study. (It should be noted that in the patient questionnaire, the type of prescription drug is mentioned as group A and group B, and the nurse entering the data is not aware of the type of prescription drug.). 2-3 Painlessness after surgery. Intervention 1: Intervention group1: Intervention Group: In the intervention group, an Optofuser analgesia pump from Darman Gostar Sepano in Iran was used. This pump had a capacity of 100 cc and operated at a speed of 4 cc per hour. A bolus dose of 0.5 cc could be administered with a 15-minute lockout period. The medication administered through this pump consisted of 0.5 mg per kilogram of morphine combined with 40 mg per kilogram of Apotel, and it was diluted with normal saline to reach a total volume of 100 cc. Intervention 2: Intervention group2: Intervention group: Ketorolac, 30 mg in people under 50 kg and 60 mg in people over 50 kg as a deep intramuscular injection that is repeated every 8 hours. Yes - There is a plan to make this available What will be shared: Protocol for the treatment of pain after cesarean section When: After the publication of the article To whom: Researchers of all disciplines Conditions: After the publication of the article Where to obtain: m.faghihshojaei@gmail.com How to obtain: m.faghihshojaei@gmail.com Comments:
public Mersede Faghihshojaei
Ghaffari blv - Birjand university of medical science
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۰۷۶ +98 56 3238 5000 m.faghihshojaei@gmail.com Birjand University of Medical Sciences scientific Mersede Faghihshojaei
Ghaffari blv - Birjand university of medical science
Birjand Iran (Islamic Republic of) 9717853076 +98 56 3238 5000 m.faghihshojaei@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers, 20-40 years old, Elective caesarean section with transverse incision Pregnancy age at least 37 weeks American Society of Anesthesiology based on II and I ASA class 20 years 40 years Female Suffering from gestational hypertension Receiving NSAID and narcotics before surgery Mothers of macrosomic and multiple babies Spinal or epidural anesthesia method history of peptic ulcer history of coagulation disorders BMI more than 30 Treatment - Drugs Treatment - Drugs Intervention group1: Intervention Group: In the intervention group, an Optofuser analgesia pump from Darman Gostar Sepano in Iran was used. This pump had a capacity of 100 cc and operated at a speed of 4 cc per hour. A bolus dose of 0.5 cc could be administered with a 15-minute lockout period. The medication administered through this pump consisted of 0.5 mg per kilogram of morphine combined with 40 mg per kilogram of Apotel, and it was diluted with normal saline to reach a total volume of 100 cc. Intervention group2: Intervention group: Ketorolac, 30 mg in people under 50 kg and 60 mg in people over 50 kg as a deep intramuscular injection that is repeated every 8 hours. Determination and comparison of the average pain intensity of the patients after the cesarean section in the group receiving intramuscular ketorolac and the group receiving morphine and Apotel by PCA pump. Timepoint: , 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the cesarean section. Method of measurement: Visual pain score(Visual Analogue Scale). The mean of hemodynamic indices (average blood pressure, heart rate and SPO2). Timepoint: 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the operation. Method of measurement: Automatic monitoring device. Frequency distribution of mothers' need to receive an additional dose of anesthesia. Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient. Frequency distribution of side effects (nausea, vomiting, abnormal sleepiness, respiratory depression, stomach pain). Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the history of the patient. Birjand University of Medical Sciences Approved 2023-09-25 Research Ethics Committees of Birjand University of Medical Sciences Ghaffari Blvd, Birjand University of Medical Sciences Birjand South Khorasan Iran (Islamic Republic of)