Investigating the effect of ketamine on the severity of pain in patients with somatic symptoms disorder with pain predominance: a randomized controlled trial

Determining and comparing the effect of ketamine on the severity of pain in patients with physical symptoms disorder with pain predominance in the intervention and control groups

Triple blinded randomized controlled trial

Samples will be selected from all psychiatric centers of Isfahan City as available samples, the selected samples will be placed in intervention and control groups in the form of double random block allocation.

Inclusion criteria: 1-diagnosis of somatic symptom disorder with severe pain complaints based on DSM-V criteria 2-informed consent 3-age group 18-60 years 4-absence of mania/hypomania his Unmet criteria: 1-presence of psychotic symptoms. 2-history of addiction or Use of drugs in the last 3 months 3-pregnant or lactating women 4-serious and uncontrolled physical patients 5- use of any medication that is prohibited to be used simultaneously with ketamine 6- untreated hypothyroidism or hyperthyroidism 7-use of compounds containing ketamine before entering the stud

Patients in the case group, in addition to their routine treatment, would be treated orally with ketamine dissolved in a glass of fruit juice at a rate of 1 mg/kg twice a week with an interval of 3 days and for 4 weeks and the patients of the control group would be treated with placebo with the same appearance and routine treatment with the same duration and the pain of the patients will be checked before the start of the treatment and immediately after the treatment and 1 month later.

Pain severity

Allocation of random double blocks in such a way that first the qualified patients who come to the clinic for the treatment of physical symptoms disorders with a predominance of pain and meet the conditions for entering the study, both them form a block first and then are divided into two groups based on the national code. are sorted and each one is randomly assigned to one of treatments A and B. The randomization method in each of these blocks is such that two sequences AB and BA will be formed. If the random number is between zero and four, people will enter the AB sequence block and the first will receive drug A and the second will receive drug B. If the random number is five to nine, the BA sequence will be performed, that is, the first one will take drug B, and the second one will take drug A, and this process will continue until the sample volume is sufficient, and after completing the work to open the code A and B are assigned to which drug, again we use random numbers zero to four or five to nine.

Only the relevant resident knows about the type of A and B drugs, and the attending physician, the patient, and the analyzer are blinded, and based on the randomization method, he prepares the A and B packages for both patients. It should be noted that he will already receive the necessary training in connection with the allocation of the type of treatment.

Lack of permission from the research ethics committee of Isfahan University of Medical Sciences