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IRCT20170212032528N2 IRCT 2018-12-10 Vice chancellor for research of Isfahan University of Medical Sciences The Comparison of Sedation Induction Time of Haloperidol, Perphenazine, Chlorpromazine, Promethazine, Trifluoperazine on Aggressive Patients The Comparison of Sedation Induction Time of Haloperidol, Perphenazine, Chlorpromazine, Promethazine, Trifluoperazine on Aggressive Patients 2016-06-21 anticipated 76 Complete https://irct.ir/trial/25321 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly divided into four groups by a psychiatric resident who participated in this study, using the same simple method. The ampoules of Haloperidol, Promethazine, Chlorpromazine, and Trifluoperazine, were labeled as 1 to 4. To divide patients into 4 groups we used Table of Random Numbers from 1 to 4. 2-3 Acute Aggression. Intervention 1: Intervention Group 1: Injection of 5mg Haloperidol (Exir, Tehran, Iran). Intervention 2: Intervention Group 2: Injection of 50 mg Chlorpromazine (TehranChemie, Tehran, Iran). Intervention 3: Intervention Group 3: Injection of 1 mg Trifluoperazine (Caspian Tamin, Gilan, Iran). Intervention 4: Intervention Group 4: Injection of 50 mg Promethazine (Alborz darou, Qazvin, Iran). 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 No more information
public Delaram Eghtesadi, M.D
Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) 8871863348 +98 31 3222 2127 Bsrc@med.mui.ac.ir Isfahan University of Medical Sciences scientific Ali Mousavi, M.D
Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) 8871866348 +98 31 3222 2127 mousavi@med.mui.ac.ir Psychiatry department of Isfahan University of Medical Sciences Iran (Islamic Republic of) Age>18 Years Have consent to enter the study by patient accompaniment Have no Contraindication for Interventional Drug (For Instance Muscle Rigidity and Neuroleptic Malignant Syndrome) Having Verbal Violence in the Time of First Visit Having Physical Violence in the Time of First Visit no limit no limit Both Patient Family's Refuse for Collaboration After the First Agreement F39 Unspecified mood [affective] disorder Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention Group 1: Injection of 5mg Haloperidol (Exir, Tehran, Iran) Intervention Group 2: Injection of 50 mg Chlorpromazine (TehranChemie, Tehran, Iran) Intervention Group 3: Injection of 1 mg Trifluoperazine (Caspian Tamin, Gilan, Iran) Intervention Group 4: Injection of 50 mg Promethazine (Alborz darou, Qazvin, Iran). Sedation Velocity. Timepoint: During the Intervention and 2 hours later after intervention. Method of measurement: Signs and Time of Aggression Registered list. Adverse Effects of Sedative Drug. Timepoint: One Hour after Injection. Method of measurement: Drug side effects check list. Vice chancellor for research of Isfahan University of Medical Sciences Approved 2016-05-21 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)