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IRCT2013011312115N1 IRCT 2014-05-11 Vice chancellor for research, Mashhad University of Medical Sciences Remifentanil for Moderate Sedation for Shoulder Reduction in the ED Comparison of Remifentanil with Fentanyl/Midazolam for Moderate Sedation for Closed Reduction of Anterior Shoulder Dislocation in Adults in the ED: a Randomized Controlled Trial 2013-02-02 anticipated 42 Complete https://irct.ir/trial/12235 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Anterior Shoulder Dislocation. Intervention 1: Patients in control group will recieve single dose fentanyl 1.5 microg/kg slowly via intravenous infusion over 30 seconds from the form of injection solution 0.05 mg/ml plus single dose midazolam 0.1 mg/kg slowly via intravenous infusion over 2 minutes from the form of injection solution 1 mg/ml. Intervention 2: In the intervention group the patients will receive remifentanil 1 microg/kg slowly via intravenous injection over 30 seconds and repeated doses every 1 minute titrated to effect from the form of injection,powder for reconstitution: 1mg, diluted to a final concentration of 50 microg/ml.
public Zamani Moghadam Hamid
Emam Reza Hospital, Emam Reza square, Avicina avenue, Mashhad.
Mashhad Iran (Islamic Republic of) +98 51 1852 5312 zamanimh@mums.ac.ir Mashhad Univercity of Medical Science scientific Azadeh Tafakori
Emam Reza Hospital, Emam Reza square, Avicina avenue, Mashhad.
Mashhad Iran (Islamic Republic of) +98 51 1852 5312 dr.azadeh.tafakori@hotmail.com Mashhad Univercity of Medical Sciences Iran (Islamic Republic of) INCLUSION CRITERIA: Those aged 18–64 years with anterior shoulder dislocation, requiring closed reduction with physical condition I (healthy and normal patients without previous medical history) and II (patients with mild systemic disease with no functional limitation) according to the classification system of American Society of Anesthesiologists (ASA) will be selected. EXCLUSION CRITERIA: The exclusion criteria included age <18 years and >64 years; History of allergy to benzodiazepines and narcotics; Prolonged use of opioids; Alcohol usage; Sleep obstructive apnea syndrome; Maxillofacial malformations with high probability of failure in maintaining the airway; Pregnant patients; Anterior dislocation requiring referral to orthopedic operating room; Patients with severe trauma; Patients in septic shock; Patients with advanced Heart disease; Kidney failure; Pneumonia; Uncontrolled seizures; Patients not willing to participate in the study. 18 years 64 years Both s43.0 Glenohumeral Joint Treatment - Drugs Treatment - Drugs Patients in control group will recieve single dose fentanyl 1.5 microg/kg slowly via intravenous infusion over 30 seconds from the form of injection solution 0.05 mg/ml plus single dose midazolam 0.1 mg/kg slowly via intravenous infusion over 2 minutes from the form of injection solution 1 mg/ml. In the intervention group the patients will receive remifentanil 1 microg/kg slowly via intravenous injection over 30 seconds and repeated doses every 1 minute titrated to effect from the form of injection,powder for reconstitution: 1mg, diluted to a final concentration of 50 microg/ml. Pain Perception. Timepoint: During Intervention. Method of measurement: Visual Analog Scale 100mm. Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of intravenous administration of the drug until hospital discharge. Procedure Time. Timepoint: During Intervention. Method of measurement: From the begining of sedatiion till end of reduction. Patient Consent. Timepoint: After Intervention. Method of measurement: Likert Scale. Non Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: Dysphoria, Vomiting, Headache, Myoclonus, Nausea, Stiffness, Rash, Cough, Bronchospasm, Laryngospasm, Stridor, Apnea, Seizures, Rash, Restlessness, Aspiration. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2012-11-04 Mashhad University of Medical Sciences Ethics Committee Vice chancellor for research Mashhad Univercity of Medical Sciences, Ghoreishi building, Daneshgah avenue, Mashhad, Iran. Mashhad Iran (Islamic Republic of)