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IRCT20200820048466N1 IRCT 2020-09-13 Arak University of Medical Sciences Comparison of the effect of ice pack and lidocaine ointment in the pain of subcutaneous enoxaparin injection Comparison of the effect of ice pack and lidocaine ointment in the pain of subcutaneous enoxaparin injection 2020-09-20 anticipated 108 Complete https://irct.ir/trial/50469 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: In this study, 108 heart patients were selected according to the inclusion criteria and by available sampling and block random allocation, by assigning the letter A to the ice pack group, the letter B to the lidocaine group and the letter C to the control group in six cases. ABC, ACB, BAC, BCA, CAB, CBA are written on separate sheets and thrown into a container and one of the sheets is randomly taken out of the container and the composition written on it is written down and again. That sheet is thrown into the container. Because the sample size in this study is 108 patients, this operation should be repeated 36 times. Each time the composition written on each sheet is written in the sequence written on the previous sheet. Then, for each letter, a number from one to one hundred and eight is assigned to the letters written in sequence, and each letter is placed in an envelope and the letter number is written on the envelope. Each time a patient is selected, one of the envelopes is opened in the order written on the envelope and it is determined that the patient should be in intervention group 1, 2 or 3, they are divided into three groups, Blinding description: In this study,to avoid bias,the use of ice packs and lidocaine ointment and enoxaparin injection is performed by one person in the group and is measured by another person in the group. N/A Pain due to Enoxaparin injection. Intervention 1: Intervention group : group 1 patients undergo ice bag intervention. one minute before the injection, the ice pack is placed on the site where the enoxaparin is to be performed. immediately after removing the ice pack, the injection site is disinfected in the usual way using normal saline and subcutaneous injection is performed by one person in both groups, immediately after the injection of the patients pain with VAS instrument measured and recorded. Intervention 2: Intervention group: Group 2 patients underwent the intervention with 5% lidocaine ointment. 2 g equals 15 cm (from 5% lidocaine ointment tube weighing 15 g) was measured with a Scaltec laboratory scale with an accuracy of 0.01 g. After performing several measurements under the same conditions, the length of the ointment used was calculated to be 15 cm. Apply lidocaine on the calibrated pad and place it on the stand. After 30 minutes, the ointment is removed from the stand. Using a checklist, the possible side effects of lidocaine ointment are investigated and recorded. Side effects of topical lidocaine include redness and irritation of the lidocaine ointment . Using a normal saline impregnated pad, the injection site is cleansed and the subcutaneous injection is performed by one person in each of the three groups. Immediately after the injection, the patient's pain is measured and recorded with a VAS instrument. Intervention 3: Control group: The control group did not perform any intervention and immediately after injection, the patient's pain was measured and recorded with a VAS instrument. Yes - There is a plan to make this available What will be shared: Article When: 2020 To whom: researchers Conditions: reseachers Where to obtain: fshahivand93@yahoo.com How to obtain: email fshahivand93@yahoo.com Comments:
public Fereydoun Shahivand
Sardasht Square
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3524 amoozesh@arakmu.ac.ir Arak University of Medical Sciences scientific Fereydoun Shahivand
Sardasht Square
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3524 amoozesh@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age 30-65 years Awareness Ability to communicate and answer questions and show the amount of pain Stability of the clinical condition No drug addiction No history of allergies to local anesthetics No known mental illness 30 years 65 years Both Canceling Discharge Transfer Patient death Treatment - Devices Treatment - Drugs N/A Intervention group : group 1 patients undergo ice bag intervention. one minute before the injection, the ice pack is placed on the site where the enoxaparin is to be performed. immediately after removing the ice pack, the injection site is disinfected in the usual way using normal saline and subcutaneous injection is performed by one person in both groups, immediately after the injection of the patients pain with VAS instrument measured and recorded. Intervention group: Group 2 patients underwent the intervention with 5% lidocaine ointment. 2 g equals 15 cm (from 5% lidocaine ointment tube weighing 15 g) was measured with a Scaltec laboratory scale with an accuracy of 0.01 g. After performing several measurements under the same conditions, the length of the ointment used was calculated to be 15 cm. Apply lidocaine on the calibrated pad and place it on the stand. After 30 minutes, the ointment is removed from the stand. Using a checklist, the possible side effects of lidocaine ointment are investigated and recorded. Side effects of topical lidocaine include redness and irritation of the lidocaine ointment . Using a normal saline impregnated pad, the injection site is cleansed and the subcutaneous injection is performed by one person in each of the three groups. Immediately after the injection, the patient's pain is measured and recorded with a VAS instrument. Control group: The control group did not perform any intervention and immediately after injection, the patient's pain was measured and recorded with a VAS instrument Patient pain rate with VAS instrument. Timepoint: Immediately after injection. Method of measurement: Visual Analogue Scale. Pain Rate. Timepoint: Immediately. Method of measurement: VAS. Arak University of Medical Sciences Approved 2020-06-28 Ethics committee of Arak university of medicine Sardasht Square Arak Markazi Iran (Islamic Republic of)