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IRCT20141121020020N7 IRCT 2021-06-08 Babol University of Medical Sciences The effect of lidocaine and cold normal saline on injection pain Comparison of the effect of lidocaine and cold normal saline on pain during propofol injection 2021-03-13 anticipated 120 Complete https://irct.ir/trial/54903 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients are randomly assigned to study groups by permutation block method. Medication is assigned by a nurse, Randomization description: Randomization is done by random blocks with block size of 6 and number of blocks of 20. First, twenty random blocks of AABBCC letter permutations are generated by the randomization site and recorded in one sheet, respectively, and then the patients will be assigned to one of the three study groups according to the permutations generated. The website address is WWW.RANDOMIZATION.COM. The tab generated by the randomization site is a tab similar to the following table: 1.A 2.B 3.B 4.C 5.A 6.C . . . 120.C Then, each patient who is admitted is assigned to one of the groups according to the above sheet and the patient's entry and the desired number, respectively, Blinding description: It is generally explained to patients that they will receive one of the three drugs of study and patients fill and sign an informed consent form. Patients who are candidates for this study are divided into three groups of 40 for lidocaine injection, cold normal saline at 4 ° C, and normal saline at room temperature as the control group. The drugs are prepared in exactly the same packaging in terms of shape and size in 10 cc syringes with a unique 4-digit code. All drugs are injected by a trained anesthetist. After injecting the drugs, the anesthesiologist leaves the room without giving further information to the researcher. In the informed consent form, the whole study process and the studied drugs are explained to the patient, but the patients are not aware of the drug they are receiving. 3 Pain at the injection site. Intervention 1: Intervention group: Lidocaine receiving group. Patients in this group receive 10 ml of 0.5% lidocaine as an intervention group. Intervention 2: Intervention group: Recipient of normal saline 4 ° C. Patients in this group receive 10 ml of normal cold saline 4 ° C as an intervention group. Intervention 3: Control group: Normal saline recipient with ambient temperature. Patients in this group receive 10 ml of normal saline at room temperature as a control group. Yes - There is a plan to make this available What will be shared: Raw and analyzed information obtained from all stages of the study When: unlimited To whom: All researchers with professional and ethical competence in the field of clinical affairs Conditions: Provided there is no conflict of interest between the researchers, the responsible institution and the patients Where to obtain: Vice Chancellor for Research, Babol University of Medical Sciences mubabol.ac.ir How to obtain: This study will be conducted according to the administrative procedure of the licensing institution. Comments:
public Shahram Seyfi
Ganj Afrouz st.
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 sh.seyfi@mubabol.ac.ir Babol University of Medical Sciences scientific Shahram Seyfi
Ganj afrouz st.
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 sh.seyfi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Indication of propofol injection Elective general anesthesia 18 years 60 years Both Known heart disease History of lidocaine sensitivity Patient dissatisfaction History of seizures History of psychiatric illness Prevention Prevention Placebo Intervention group: Lidocaine receiving group. Patients in this group receive 10 ml of 0.5% lidocaine as an intervention group. Intervention group: Recipient of normal saline 4 ° C. Patients in this group receive 10 ml of normal cold saline 4 ° C as an intervention group. Control group: Normal saline recipient with ambient temperature. Patients in this group receive 10 ml of normal saline at room temperature as a control group. Pain severity at the injection site. Timepoint: At beginning, at 15 and 30 seconds after injection. Method of measurement: Questionnaire and VAS scoring scale. Babol University of Medical Sciences Approved 2020-08-31 Ethics Committee of Babol University of Medical Sciences Ganj Afrouz St. Babol Mazandaran Iran (Islamic Republic of)