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IRCT20110818007369N6 IRCT 2018-02-21 Rasht University of Medical Sciences Comparison of Remifentanil with Combined Propofol and Fentanyl Medications for Sedative and Analgesic Effects in the Treatment of Shoulder Dislocation PSA, VAS, ED Comparison of Remifentanil with Combined Propofol and Fentanyl Medications for Sedative and Analgesic Effects on Patients with Anterior Shoulder Dislocation Treated by Closed Reduction, A Double-Blind Randomized Clinical Trial 2017-10-23 anticipated 60 Complete https://irct.ir/trial/28110 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: According to the sample size calculated in this study, which equals to 30 patients in each group, they are randomly placed in two groups by random block method. Random sequences are generated with a 1:1 ratio using the random generator program. Generated sequences or labels A and B are put in sealed envelopes at the Emergency Nursing Station, Blinding description: The present study is double-blind. An emergency medical specialist working in the hospital gives drugs according to the generated sequences in the same covered encoded syringes to the related residents without having any information on them, and if re-injection is necessary, s(he) will give them the medicine. Also, the patient and the person evaluating the outcome are not aware of the type of injectable drugs. 3 anterior shoulder dislocation. Intervention 1: Intervention group: Remifentanil (1 μg/kg) will be injected intravenously. Remifentanil (0.5 μg/kg) can be repeated three times at the most, and if needed, the drug will be injected after measuring visual analogue scale. Intervention 2: Control group:A combination of propofol (1 mg/kg) and fentanyl (1 μg/kg) will be injected intravenously. For reinjection, the dose of propofol is 0.5 mg/kg, and if needed, the drugs will be injected after measuring visual analogue scale. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It has not been decided yet.
public Marjan Aghajani Nargesi
Unit 2, 1st Floor, No. 11, St. 186, Guilan Blvd., Golsar
Rasht Iran (Islamic Republic of) 4166813315 +98 13 3377 4858 info@gtrc.ir Rasht University of Medical Sciences scientific Vahid Monsef Kasmaei
Poursina Hospital, Poursina Crossroads, Namjoo Ave.
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3332 2444 vmonsef@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) The patients referring to the emergency department of Poursina hospital with acute anterior shoulder dislocation requiring closed reduction 15 years 60 years Both The patients who have been diagnosed with fracture-dislocation of the shoulder joint, except those suffering from Hill-Sachs lesions The patients with decreased GCS and unstable hemodynamic status The patients with immature skeletal system (open epiphysis) or the patients who have undergone surgery previously and have had a fracture in the same shoulder The patients who are allergic to soy and eggs The patients with reduced blood pressure (Systolic Blood Pressure<90 mm Hg) The patients with heart failure The patients over the age of 60 and under the age of 15 years S43.0 Unspecified subluxation and dislocation of shoulder joint Treatment - Drugs Treatment - Drugs Intervention group: Remifentanil (1 μg/kg) will be injected intravenously. Remifentanil (0.5 μg/kg) can be repeated three times at the most, and if needed, the drug will be injected after measuring visual analogue scale. Control group:A combination of propofol (1 mg/kg) and fentanyl (1 μg/kg) will be injected intravenously. For reinjection, the dose of propofol is 0.5 mg/kg, and if needed, the drugs will be injected after measuring visual analogue scale. Amount of side effects following drug injection such as agitation, nausea, vomiting, and apnea. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Based on the resident report. Starting time of reduction after the drug injection. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Since drug injection until patient sedation in seconds. Severity of pain. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: The severity of pain before, during, and after joint reduction is measured according to the visual analogue scale based on the patient's statement. Amount of trouble-freeness in the shoulder joint reduction. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Based on the resident report. Stay length in the emergency ward. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Since the beginning of injection until the end of the recovery (full consciousness) in the patient in minutes. The need for re-injection of the drug. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: The inadequacy of the sedative and analgesic effects leading to re-inject repeated dose of the drug. Duration analgesic effect after the drug injection. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Duration of the sedative and analgesic effects after the injection in minutes. Rasht University of Medical Sciences Approved 2017-10-21 Ethics Committee of Guilan University of Medical Sciences Deputy of Research and Technology, opposite to 17 Shahrivar Hospital, Shahid Siadati St., Namjoo Ave. Rasht Guilan Iran (Islamic Republic of)