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IRCT20201210049672N2 IRCT 2022-03-19 Vice-Chancellery for Research Hormozgan University of Medical Sciences Comparison of different doses of ketamine and propofol for changing the dressing in burn patients Comparison of different doses of ketamine and propofol for sedation and analgesia for changing the dressing in burn patients 2022-02-20 anticipated 120 Complete https://irct.ir/trial/62522 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 120 unclear envelopes and 120 cards with the names of the groups (A, B) will be prepared (60 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A or B based on the card inside the selected envelope, Blinding description: The solutions will be prepared for injection in advance by an individual not involved in the study and they will only have labels indicating the groups of the study; therefore, the patients, the investigator, the care giver, and the outcome assessor will be unaware of the injected drugs. 3 Second- and third-degree burns. Intervention 1: Intervention group: First the patient will receive 1-2 mg intravenous ketamin (MFR:Sterop Co., Belgium) for induction (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). During the procedure, whenever the patient's pain score is >3 based on his/her facial expression, 1-3 ml propofol 1% will be injected (each ampule contains 200 mg propofol 1%/20 ml, DoNcKood.phar Co. Korea) in divided intravenous doses (taking 30-100 μ/kg/min as reference based on the interval between injections and the patient's weight). Intervention 2: Intervention group: Ketamine will be diluted with distilled water so that each 1 ml contains 10 mg ketamine (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). Then, equal proportions of ketamine and propofol 1% (each ampule contains 200 mg propofol 1%/20 ml) will be mixed in a 10-ml syringe so that each ml of this 0.5% ketofol 0.5% mixture contains 5 mg ketamine and 5 mg propofol. Then, first 0.5-1 mg/kg of the mixture will be injected intravenously for induction. During the procedure, whenever the patient's pain score is >3, 0.1-0.5 mg/kg of the same mixture will be injected. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Bibimona Razavi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 bibimonarazavi.hums@gmail.com Bandare-abbas University of Medical Sciences scientific Bibimona Razavi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 979199155 +98 76 3334 5009 bibimonarazavi.hums@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age 15-65 years Second- and third-degree burns Burn area of 10-70% Daily dressing change before skin graft in the operating room with American Society of Anesthesiologists (ASA) class 1-3 Ability to speak and perceive the Persian language 15 years 65 years Both Drug addiction Respiratory and cardiac diseases Renal disorders Hypersensitivity to analgesic drugs, ketamine, and propofol History of psychiatric disorders History of seizure American Society of Anesthesiologists (ASA) class >3 Z48.00 Encounter for change or removal of nonsurgical wound dressing Treatment - Drugs Treatment - Drugs Intervention group: First the patient will receive 1-2 mg intravenous ketamin (MFR:Sterop Co., Belgium) for induction (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). During the procedure, whenever the patient's pain score is >3 based on his/her facial expression, 1-3 ml propofol 1% will be injected (each ampule contains 200 mg propofol 1%/20 ml, DoNcKood.phar Co. Korea) in divided intravenous doses (taking 30-100 μ/kg/min as reference based on the interval between injections and the patient's weight). Intervention group: Ketamine will be diluted with distilled water so that each 1 ml contains 10 mg ketamine (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). Then, equal proportions of ketamine and propofol 1% (each ampule contains 200 mg propofol 1%/20 ml) will be mixed in a 10-ml syringe so that each ml of this 0.5% ketofol 0.5% mixture contains 5 mg ketamine and 5 mg propofol. Then, first 0.5-1 mg/kg of the mixture will be injected intravenously for induction. During the procedure, whenever the patient's pain score is >3, 0.1-0.5 mg/kg of the same mixture will be injected. Pain intensity. Timepoint: At the end of the procedure. Method of measurement: Visual Analogue Scale. Sedation. Timepoint: At the end of the procedure. Method of measurement: Ramsay Sedation Scale. Patient satisfaction. Timepoint: At the end of the procedure. Method of measurement: Poor/moderate/good/excellent. Surgeon satisfaction. Timepoint: At the end of the procedure. Method of measurement: Poor/moderate/good/excellent. Vice-Chancellery for Research Hormozgan University of Medical Sciences Approved 2021-01-12 Ethics Committee of Hormozgan University of Medical Sciences Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine Bandar Abbas Hormozgan Iran (Islamic Republic of)