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IRCT20231029059896N1 IRCT 2023-11-13 Mazandaran University of Medical Sciences The effect of lidocaine spray in reducing ophthalmic neuralgia in patients with multiple sclerosis The effect of lidocaine spray in reducing ophthalmic neuralgia in patients with multiple sclerosis 2023-10-23 anticipated 76 Complete https://irct.ir/trial/73442 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All identified patients will be included in the study and there is no need to calculate the sample size. The total sample size in two groups is 76 people, which is due to the fact that people enter the treatment center on weekdays by accident. First, eligible patients are taken from the average admission unit and then they are randomly divided into two groups based on the number of eligible patients. This is because the size of the two groups is almost equal, while the sample size in each group is 34 people, after considering 10% attrition, 38 people in each group and a total of 76 people are selected. For random assignment Random Allocation software was used for two groups and they were selected in blocks of 8 and assigned to two study groups, Blinding description: After selecting the samples, none of the samples will be aware of the randomization and the process of allocating groups. Patients enter the study numbers in order. Lidocaine and normal saline spray is in the same packaging and the color of both consumed is the same. The time of spray use is in the pain time and this will be explained to the participants to consume 2 puffs of spray (equivalent to 1.2 mg). The evaluation at all stages mentioned above is the student who is unaware of the drugs. In our study, the patient and the evaluation have been blinded. And the neurologist is aware of the prescription drug. 2-3 Multiple sclerosis. Intervention group : 10% lidocaine nasal spray, 2 puffs of the spray (equivalent to 0.2 mg) to be used during pain.. 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 more information.
public Dr Maryam Daneshian
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 daneshian8@gmail.com Mazandaran University of Medical Sciences scientific Maryam Daneshian
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 daneshian8@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Definite MS confirmed by MRI Confirmation of ophthalmic neuralgia without response to drug treatment Performing a lidocaine sensitivity test and proving the absence of lidocaine sensitivity The patient's willingness to participate in the study and obtain informed consent The patient's MS must be of the relapsing remitting type and must have been approved by a neurologist. 20 years 50 years Both Occurrence of drug side effects Worsening of symptoms. Patient dissatisfaction More than three months have passed since the diagnosis of their disease and they have entered the chronic phase G35 Multiple sclerosis Treatment - Drugs Intervention group : 10% lidocaine nasal spray, 2 puffs of the spray (equivalent to 0.2 mg) to be used during pain. The primary outcome of the patient's pain intensity based on Visual Analogue Scale (VAS) criteria. Timepoint: Before using the spray. Method of measurement: These outcomes are measured by a neurologist based on the VAS. Measurement of pain-free time after each use of the spray​. Timepoint: The pain-free period after using the spray during pain is recorded in 0-6-12-24 hours and more than one week from the patients. Method of measurement: These outcomes are measured by the evaluator, who is a final year medical student who is not aware of the assignment of the subjects to each of the two allocation groups and the drugs used. Pain-free time after using the spray during pain in hours 0-6-12-24 and more than one week of patients are recorded. The instrument for measuring this variable is based on the patient's statements and its unit is amount of hours. Mazandaran University of Medical Sciences Approved 2023-09-23 Ethic committee of mazandaran of medical sciences Mazandaran University of medical sciences, at the begining of Valiasr Highway, Joibar three ways, imam Square,Sari, Mazndaran Province Sari Mazandaran Iran (Islamic Republic of)