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IRCT20231126060194N1 IRCT 2024-02-14 Zahedan University of Medical Sciences Evaluation of analgesic effect of diluted lidocaine spray in reducing pain caused by burning debridement in burning patients admitted to Ali-ebn Abitaleb Hospital in Zahedan between 2022 and 2023 Evaluation of analgesic effect of diluted lidocaine spray in reducing pain caused by burning debridement in burning patients admitted to Ali-ebn Abitaleb Hospital in Zahedan between 2022 and 2023 2023-12-05 anticipated 60 Complete https://irct.ir/trial/73994 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then, based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations, they are assigned to the desired group (2). These blocks were created using statistical software R version 4.0.2, Blinding description: In this research, single blinding method is used. So that the patient will not be aware of the intended intervention. Table 1: The practical method of assigning patients to two groups with the permutation block stratified randomization method Age ≤ 30 > 30 gender male female male female Groups BAAB AABB BAAB ABBA BBAA ABAB AABB ABBA ABBA AABB ABAB ABAB BABA BABA BAAB ABBA ABAB ABAB BBAA BAAB ABAB AABB AABB ABBA BBAA AABB BAAB BABA BBAA AABB AABB BAAB BBAA BABA BAAB AABB ABBA ABAB BAAB ABAB. 3 Pain after a burn. Intervention 1: Intervention group: The group that receiving lidocaine medicine. Intervention 2: Control group: The group that receiving pethidine drug. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts after the results are printed To whom: It will be available for researchers working in academic and scientific institutions Conditions: 1- The goal should be clear 2- The possibility of using in future studies Where to obtain: Amirali Divsalar amiralidivsalar@gmail.com Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran 98-054-33372013 How to obtain: You can request by sending an email, the documents will be sent within a maximum of one week Comments:
public masoumeh abbasnjad
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
zahedan Iran (Islamic Republic of) 9816743463 0543337215 Amiralidivsalar@gmail.com Zahedan University of Medical Sciences scientific masoumeh abbasnejad
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 Amiralidivsalar@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) 1. Informed and free consent to participate in the study 2. Burn severity above 10% 3. Patients admitted to the burn department of Ali Bin Abi Talib Zahedan Hospital no limit no limit Both 1. Impaired level of consciousness (GCS < 15) 2. Hemodynamic disturbance during drug injection (SBP ≤ 90 and PR ≤ 60 and RR ≤ 8 and ≥ 90% (O2) and in patients with blood pressure (SBP ≤ 180) or (SBP ≤ 100) ) 3. Use of drugs or alcohol or sedatives or pain relievers in the last 48 hours 4. History of taking MAOI, TCA, SSRI, phenothiazines or sleeping pills 5. Suffering from chronic diseases (congenital or acquired heart diseases, heart failure chronic liver disease, biliary tract diseases, kidney failure and chronic lung disease) according to history and clinical examination 6. Asthma according to history and clinical examination 7. Allergy to lidocaine and pethidine 8. Weight more than 100 kg 9. Lack of consent to enter the study 10. Patient's lack of cooperation G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: The group that receiving lidocaine medicine Control group: The group that receiving pethidine drug Change in the amount of pain reported by the patient (pain measured by visual observation). Timepoint: The pain level will be asked and recorded at times 0, 5, 10, 20, 30, and 60 minutes. Method of measurement: VAS criterion. Analgesia onset time in patients receiving lidocaine and IV pethidine. Timepoint: Time after starting to receive lidocaine (in minutes). Method of measurement: Time in minutes. Zahedan University of Medical Sciences Approved 2023-11-12 Ethics committee of zahedan university of medical sciences Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)