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IRCT20230228057570N1 IRCT 2023-07-12 Ilam University of Medical Sciences Comparison of the effect of ketamine and pethidine on pain control Comparison of the effects of ketamine and pethidine on pain control after surgery in upper and lower limbs orthopedic surgery candidates 2023-08-23 anticipated 80 Complete https://irct.ir/trial/68914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balance block randomization method will be used for random allocation of participants. for that, 6 blocks with 4 permutations will be created in the following order 1=KKPP 2=KPKP 3=KPPK 4=PKPK 5=PPKK 6=PKKP where P represents pethidine group and K represents ketamine group. Then, based on the numbers in the random table, a number will be chosen randomly, and based on the last digit on the right, one of the groups will be used to determine the sequence of randomization. It should be noted that if the number on the right side is zero or 7 to 9 when choosing a random number, that number will not be considered and a random number will be selected again. This process, will continue until all 80 participants are assigned to two groups. It should be noted that this method will prevent the unbalance of the two groups as well as the identification of the randomization sequence, Blinding description: For blinding, each drug will be assigned a code that can only be identified by the principal investigator and neither the patient nor the person who is collecting data will unknow what drug the patient has taken. For this purpose, the same cover and appearance of the medicine vials will be prepared. 3 Condition 1: Fracture of upper limb. Condition 2: Fracture of lower limb. Intervention 1: Intervention group: The patients in the ketamine group will receive ketamine at a dose of 0.3mg/kg 30 minutes after the induction of anesthesia. For this purpose, the patients will undergo standard monitoring (pulse oximetry, heart rate, blood pressure, and echocardiography) before surgery, and the vital signs of the patients will be evaluated and recorded every 5 minutes in the first 15 minutes. Then this process repeated every 15 minutes. Induction of anesthesia in all patients is as follows: they will be anesthetized with 2mg/kg propofol, 2ug/kg fentanyl, and 0.5mg/kg atracurium, and then the patients will undergo tracheal intubation. Anesthesia will be continued with a mixture of oxygen and nitrous oxide in equal proportions and isoflurane equivalent to MAC and continuous injection of atracurium at a dose of 0.2mg/kg. Intervention 2: Control group: for patients in the pethidine group, the extubation will be done after surgery and in a suitable situation. When patients get consciousness, pethidine will be injected with the dose of 1mg/kg slowly and intravenously, then the patients will be transferred to recovery and under standard monitoring again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamed Azadi
Haidari street, Ilam
Ilam Iran (Islamic Republic of) 6931975397 +98 84 3333 4500 azadi_eyvan_2012@yahoo.com Ilam University of Medical Sciences scientific Reza Pakzad
Ilam University of Medical Sciences campus, Banganjab, Research Blvd
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 rezapakzad2010@yahoo.com Ilam University of Medical Sciences Iran (Islamic Republic of) candidate for elective orthopedic surgery with general anesthesia and class l and ll in the ASA classification Age range from 18 to 60 years No history of opioid addiction Absence of underlying diseases such as: liver and kidney failure, history of seizures, pregnancy and breastfeeding, high ICP (intracranial pressure) and glaucoma, thyrotoxicosis, high blood pressure, diabetes, heart disease and history of disease respiratory No history of disorders such as mental retardation or psychological illness No history of drug sensitivity to pethidine or ketamine No history of chronic use of painkillers 18 years 65 years Both opioid addiction underlying diseases such as: liver and kidney failure, history of seizures, pregnancy and breastfeeding, high ICP (intracranial pressure) and glaucoma, thyrotoxicosis, high blood pressure, diabetes, heart disease and history of disease respiratory mental retardation or psychological illness drug sensitivity to pethidine or ketamine chronic use of painkillers T10 S82 Fracture of upper limb, level unspecified Fracture of lower leg, including ankle Treatment - Drugs Treatment - Drugs Intervention group: The patients in the ketamine group will receive ketamine at a dose of 0.3mg/kg 30 minutes after the induction of anesthesia. For this purpose, the patients will undergo standard monitoring (pulse oximetry, heart rate, blood pressure, and echocardiography) before surgery, and the vital signs of the patients will be evaluated and recorded every 5 minutes in the first 15 minutes. Then this process repeated every 15 minutes. Induction of anesthesia in all patients is as follows: they will be anesthetized with 2mg/kg propofol, 2ug/kg fentanyl, and 0.5mg/kg atracurium, and then the patients will undergo tracheal intubation. Anesthesia will be continued with a mixture of oxygen and nitrous oxide in equal proportions and isoflurane equivalent to MAC and continuous injection of atracurium at a dose of 0.2mg/kg. Control group: for patients in the pethidine group, the extubation will be done after surgery and in a suitable situation. When patients get consciousness, pethidine will be injected with the dose of 1mg/kg slowly and intravenously, then the patients will be transferred to recovery and under standard monitoring again. Pain score based on Visual Analogue Scale tool. Timepoint: at recovery room, 6 and 12 hours after surgery. Method of measurement: Visual Analogue Scale tools. Ilam University of Medical Sciences Approved 2023-06-18 Ethics committee of Ilam University of Medical Sciences Ilam University of Medical Sciences campus, Banganjab, Pazhohesh Blvd Ilam Ilam Iran (Islamic Republic of)