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IRCT20180129038549N14 IRCT 2021-12-15 Esfahan University of Medical Sciences Effect of local cooling in pain reduction Local skin cooling to reduce pain associated with local buffered lidocaine infiltration 2021-12-06 anticipated 108 Complete https://irct.ir/trial/60363 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the arrival of the patients to the emergency department, they are divided into 2 groups by a computer-generated random number table with 4 blocks. The selected subjects will be divided into each study group in a randomized block method using 6 rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). Ice cube group (A) and control group (B). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined, Blinding description: A trained operating room technician performs local cooling in the case group. The wounds of patients in both groups are repaired by the doctor's colleagues and then all the information is collected by a researcher who was blinded to randomization. 3 Lidocaine injection pain. Intervention 1: Intervention group: In the intervention group, an ice cube measuring 2 × 2 × 2 cm (at 0 ° C) in sterile gloves is placed on the wound for 2 minutes, and then buffered lidocaine injection is performed. Immediately after injection, each patient is evaluated to rate the pain using the visual analogue scale (VAS) from 0 to 10. Intervention 2: Control group: In the control group, no ice cube is used before injecting buffered lidocaine. Yes - There is a plan to make this available What will be shared: All of the data after coding When: Six month after publication To whom: Everyone Conditions: For seemingly studies data released to the academic chairman Where to obtain: Isfahan University of Medical Sciences How to obtain: Emailing to farhad_heidari@med.mui.ac.ir Comments:
public Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences scientific Farhad Heydari
No 7, Aria Building, Sohrevardi Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3776 9818 drfarhadheydari@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adult patients referred to the emergency department Willing to participate in the study Superficial wound/laceration of arm/forearm, ≤5 cm2 Alert 18 years 70 years Both Visual, mental, or verbal disorders Multiple trauma Unstable vital sign A history of peripheral neuropathy A history of an allergic reaction to local anesthetics G89.1 Acute pain, not elsewhere classified Treatment - Drugs Placebo Intervention group: In the intervention group, an ice cube measuring 2 × 2 × 2 cm (at 0 ° C) in sterile gloves is placed on the wound for 2 minutes, and then buffered lidocaine injection is performed. Immediately after injection, each patient is evaluated to rate the pain using the visual analogue scale (VAS) from 0 to 10. Control group: In the control group, no ice cube is used before injecting buffered lidocaine. The severity of pain. Timepoint: After lidocaine injecton. Method of measurement: Visual Analogue Scale. Drug side effects such as redness, whitening and skin blemishes. Timepoint: Until the time of discharge. Method of measurement: Standard questionnaire form. Esfahan University of Medical Sciences Approved 2019-06-02 Ethics committee of Isfahan University of Medical Science Isfahan University of Medical Science, Hezarjrib Street, Isfahan City Isfahan Isfehan Iran (Islamic Republic of)