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IRCT20220824055790N1 IRCT 2022-09-13 Kerman University of Medical Sciences Comparison of Ketamin/Propofol (Ketofol) and Etomidate /Fentanyl (Etofen) in reduction of shoulder dislocation Comparison of Ketamin/Propofol (Ketofol) and Etomidate /Fentanyl (Etofen) combinations for procedural sedation and analgesia of anterior shoulder dislocation reduction in Emergency Department: A Randomized Clinical Trial 2022-10-23 anticipated 46 Complete https://irct.ir/trial/65534 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to one of the Ketofol or Etofen groups. Randomization is done using a table of random numbers and by the block randomization method and in blocks of 5 people. In this way, a number is blindly selected from the table of random numbers for each position, and the two digits on the right side of it, if they are between 1 and 46, will be assigned to that position. Each of the blocks of 5 people is assigned to one group (Ketofol or Etofen). The odd blocks belong to the Ketofol group and the even blocks belong to the Etofen group. Block positions are numbered (1 to 46). For example, the first case that is randomly assigned to Ketofol group will enter the number one position of the first block (the block related to Ketofol) and this process will be done until the positions are filled and the number of samples in the two groups will be equal. , Blinding description: Ketamin and Fentanyl drugs are colorless and have no difference in color, and the patient does not know which compound is being injected. Propofol is milky. Etomidate is available in two milky and colorless forms. A milky etomidate is used for the study to be similar to Propofol. Therefore, in each of the study groups, a colorless compound + a milky compound is used, and the patient is unaware of the type of drug. 2-3 Anterior Shoulder Dislocation. Intervention 1: Intervention group: According to the PSAs protocol, Ketofol with a dose of 0.75 mg/kg IV bolus of ketamine and propofol are given as starting doses. A repeat dose of 0.375 mg/kg ketamine and propofol every 3 minutes is given until adequate sedation is achieved. The goal of sedation in this study is to reach the patient's level of moderate sedation. The patient is apparently unconscious, but reacts with skin irritation. After the patient reaches the appropriate level of sedation, the emergency physician performs the sedation using the Liddle Meyer maneuver. And in case of failure, the same maneuver is repeated once more, and if it is still not successful, the next maneuver is traction. After successful reduction, the pain score, the number of reduction attempts, and the length of stay in the emergency room are measured. Intervention 2: Intervention group: According to the PSAs protocol, Etofen with a dose of 0.15 mg/kg IV bolus of etomidate and 0.15 µg/kg of fentanyl are given as starting doses. A repeat dose of 0.1 mg/kg etomidate every 2 minutes is given until adequate sedation is achieved. The goal of sedation in this study is to reach the patient's level of moderate sedation. The patient is apparently unconscious, but reacts with skin irritation. After the patient reaches the appropriate level of sedation, the emergency physician performs the sedation using the Liddle Meyer maneuver. And in case of failure, the same maneuver is repeated once more, and if it is still not successful, the next maneuver is traction. After successful reduction, the pain score, the number of reduction attempts, and the length of stay in the emergency room are measured. Yes - There is a plan to make this available What will be shared: Measured variables are available after unidentifiable individuals. When: Up to one year after publish results. To whom: All people in the research centers. Conditions: Allowed for any use. Where to obtain: Seyed Mojtaba Habibi Khorasani mojista.1375@gmail.com How to obtain: After contacting and knowing the identity of the person, information will be provided to them. Comments:
public Seyed Mojtaba Habibi Khorasani
Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mojista.1375@gmail.com Kerman University of Medical Sciences scientific Masoumeh Nazemi Rafei
Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 m_nazemi_r@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Adults between 18 and 50 years old Anterior shoulder dislocation 18 years 50 years Both History of allergy to any of the drugs (ketamine, propofol, etomidate, fentanyl) underlying cardiovascular disease lung diseases nervous system diseases (central or peripheral) history of current drug or stimulant abuse now or in the last month associated fracture neurovascular symptoms patient dissatisfaction associated diseases S43.0 Subluxation and dislocation of shoulder joint Treatment - Drugs Treatment - Drugs Intervention group: According to the PSAs protocol, Ketofol with a dose of 0.75 mg/kg IV bolus of ketamine and propofol are given as starting doses. A repeat dose of 0.375 mg/kg ketamine and propofol every 3 minutes is given until adequate sedation is achieved. The goal of sedation in this study is to reach the patient's level of moderate sedation. The patient is apparently unconscious, but reacts with skin irritation. After the patient reaches the appropriate level of sedation, the emergency physician performs the sedation using the Liddle Meyer maneuver. And in case of failure, the same maneuver is repeated once more, and if it is still not successful, the next maneuver is traction. After successful reduction, the pain score, the number of reduction attempts, and the length of stay in the emergency room are measured. Intervention group: According to the PSAs protocol, Etofen with a dose of 0.15 mg/kg IV bolus of etomidate and 0.15 µg/kg of fentanyl are given as starting doses. A repeat dose of 0.1 mg/kg etomidate every 2 minutes is given until adequate sedation is achieved. The goal of sedation in this study is to reach the patient's level of moderate sedation. The patient is apparently unconscious, but reacts with skin irritation. After the patient reaches the appropriate level of sedation, the emergency physician performs the sedation using the Liddle Meyer maneuver. And in case of failure, the same maneuver is repeated once more, and if it is still not successful, the next maneuver is traction. After successful reduction, the pain score, the number of reduction attempts, and the length of stay in the emergency room are measured. Pain score: using numerical rating scale. Timepoint: During Reduction. Method of measurement: Ask the patient: Score from 1 to 10. Number of reduction attempts until reduction succeeds. Timepoint: During study until reduction succeeds. Method of measurement: -. Length of stay in the emergency room: the time between the patient's admission to the emergency room and discharge. Timepoint: After discharge. Method of measurement: View the patient file. Drug side effects: bradycardia, respiratory depression, hypotension. Timepoint: During Study. Method of measurement: Based on the form of drug side effects. Kerman University of Medical Sciences Approved 2022-07-31 Ethics commitee of Kerman Medical University University of Medical Sciences, The beginning of Haft Bagh Alavi axis, Kerman Kerman Kerman Iran (Islamic Republic of)