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IRCT20210829052318N1 IRCT 2022-05-24 Shahid Beheshti University of Medical Sciences The effect of lidocaine on pain, spasm and vasovagal syndrome The effect of injectable lidocaine with and without topical lidocaine P ointment on pain, spasm and vasovagal syndrome in patients undergoing radial artery angiography 2021-10-07 anticipated 80 Complete https://irct.ir/trial/58391 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Step 1: Create a random sequence. A simple random method in which randomization is based on a single sequence of random allocations. The method of randomization is a table of random numbers. The researcher first determines the table to read the numbers (for example, right), then the numbers will be considered for different groups (for example, even numbers for intervention A and odd numbers for intervention B), then the researcher on one It gives up numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups. Step 2: Hide the allocation: Use randomly coded boxes: In these boxes, the intervention or the sheets in which the random allocation is registered will be used. Step 3: Execute the random allocation process: In order to create a random sequence, the participants will be examined in terms of entry and exit criteria and their names will be registered and the participants will be assigned to groups separate from the researchers, Blinding description: In the present study, all eligible patients will be unaware of the contents of the ointments used and applied and the effects of the ointment, and the ointment tube will be covered by a cover. 3 Coronary angiography patients through radial artery. Intervention 1: Intervention group: Treatment with topical cream (lidocaine / prilocaine) under the brand name Zila-P in patients undergoing angiography. Each 100 grams contains: 2.5 grams of lidocaine and 2.5 grams of prilocaine. Produced by Tehran Shimi Pharmaceutical Company. At a rate of 3 grams and put padded glue on it. Intervention 2: Control group: Patients who did not use any ointment. 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 I have not decided yet - the release schedule is not yet known
public Dr. Saeed Alipour Parsa
Tehran, Shahid Chamran Highway, Yemen St., Shahid Shahriari Square, Daneshjoo Blvd.
Tehran Iran (Islamic Republic of) 1983969411 +98 44 3422 4499 saeedalip@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Saeed Alipour Parsa
Tehran, Shahid Chamran Highway, Yemen St., Shahid Shahriari Square, Daneshjoo Blvd.
Tehran Iran (Islamic Republic of) 1983969411 +98 44 3422 4499 saeedalip@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) No Arthropathy in the upper extremities Allen normal test No Raynaud's disease No Q wave infarction in the past week No history of contrast agent allergy Satisfaction with the research people over 18 years old 18 years no limit Both History of allergies to this ointment History of structural disorders such as wrist surgery Having a weak pulse Having a high INR History of fistula in hand Treatment - Drugs N/A Intervention group: Treatment with topical cream (lidocaine / prilocaine) under the brand name Zila-P in patients undergoing angiography. Each 100 grams contains: 2.5 grams of lidocaine and 2.5 grams of prilocaine. Produced by Tehran Shimi Pharmaceutical Company. At a rate of 3 grams and put padded glue on it Control group: Patients who did not use any ointment. Pain score according to the patient's statement and based on VAS. Timepoint: During angiography. Method of measurement: Patient statement based on Visual analogue scale(VAS). Shahid Beheshti University of Medical Sciences Approved 2022-02-21 Ethics committee of Shahid Beheshti University of Medical Sciences District 7, Madani St., Shemirani Alley, No. 60, first floor Tehran Tehran Iran (Islamic Republic of)