Comparison of the effects of ketamine and pethidine on pain control after surgery in upper and lower limbs orthopedic surgery candidates

Comparison of the effect of ketamine and pethidine on pain control after orthopedic surgery

The randomized double-blind controled clinical trial, phase 3 on 80 patients. ralloc package in stata was used for randomization

After selecting the participants from Imam Khomeini Hospital, the patients will be divided into two groups with a random block approach. In the end, the pain score will be measured by considering blinding.

Inclusion: candidate for elective orthopedic surgery with general anesthesia and class l and ll in the ASA classification 18 to 60 yrs old 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 drug sensitivity to pethidine or ketamine Exclusion: 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

In the intervention group, Patients will receive ketamine at a dose of 0.3mg/kg 30 minutes after induction of anesthesia. for the control group, Patients will not receive any other drug during anesthesia. After the surgery, when the extubating conditions are suitable, the patient's tracheal tube will be removed and after regaining consciousness, they will receive this medicine at the same dose of 1mg/kg slowly and intravenously.

Pain score in two group

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.

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.