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IRCT20180129038549N10 IRCT 2021-05-12 Esfahan University of Medical Sciences Evaluation of the effect of lidocaine-ibuprofen cream in reducing local pain Effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-ibuprofen combination cream in reduction of pain during central venous catheterization 2021-05-16 anticipated 100 Complete https://irct.ir/trial/56126 interventional Randomization: Randomized, Blinding: Double 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, Blinding description: First, Lidocaine-ibuprofen cream is prepared by the Faculty of Pharmacy of Isfahan University of Medical Sciences and the same is packed with Xyla-P cream, and then numbered and given to the nurse. The nurse and the physician and the patient do not know the ointment content. 3 Procedural pain. Intervention 1: Intervention group: Patients are treated with Xyla-P cream. A 5% Xyla-P cream is a combination of 2.5% lidocaine and 2.5% perlocaine produced by Iranian chemistry company Iran. For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas. Intervention 2: Intervention group: Patients are treated with lidocaine-ibuprofen cream. This cream is a combination of 2% lidocaine and 5% ibuprofen and is prepared with the Faculty of Pharmacology (Isfahan University of Medical Sciences). . For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas. Yes - There is a plan to make this available What will be shared: All of data after coding When: Six month after publication To whom: Everyone Conditions: For seemingly studies data released to academic chairman's 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 Reza Azizkhani
Alzahra hospital, Sofeh Ave.
Isfahan Iran (Islamic Republic of) 8177777645 +98 31 3620 2020 azizkhani1980@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All adult patients referred to the emergency department of al-Zahra and Kashani hospitals Need for Central Venous Catheter Insertion Alert Stable vital signs 18 years no limit Both Visual, mental, or verbal disorders History of favism, methemoglobin, renal and liver disease Skin diseases at or around the CVC insertion site History of drug addiction History of analgesic use within 24 hours before the procedur G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Patients are treated with Xyla-P cream. A 5% Xyla-P cream is a combination of 2.5% lidocaine and 2.5% perlocaine produced by Iranian chemistry company Iran. For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas. Intervention group: Patients are treated with lidocaine-ibuprofen cream. This cream is a combination of 2% lidocaine and 5% ibuprofen and is prepared with the Faculty of Pharmacology (Isfahan University of Medical Sciences). . For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas. The severity of pain. Timepoint: After central venous catheter (CVC) insertion. 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. The severity of pain. Timepoint: After lidocaine injection. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2019-07-28 Ethics committee of Isfahan University of Medical Science Isfahan University of Medical Science, Hezarjrib Street, Isfahan City Isfahan Isfehan Iran (Islamic Republic of)