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IRCT20210720051946N6 IRCT 2024-01-07 Shahid Beheshti University of Medical Sciences Effect of diazepam and haloperidol in controlling agitation Comparison of the effect of diazepam alone and in combination with haloperidol in controlling agitation caused by stimulants 2023-12-14 anticipated 60 Complete https://irct.ir/trial/74343 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the desired patients (N=60) were selected, the patients were randomly and double-blindly divided into intervention and control groups. The randomization method was the use of black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. Also, in order to blind the patients, they will be blinded to the other group. In the continuation of the treatment of the patients, in the diazepam group, this drug will be used with a dose of 10 mg, and in the diazepam (10 mg) + haloperidol (5 mg) group, this drug will be used. In the following, to evaluate the level of agitation, the evaluation of the level of sedation is used and its level is determined, Blinding description: After the desired patients (N=60) were selected, the patients were randomly and double-blindly divided into intervention and control groups. The randomization method was the use of black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. Also, in order to blind the patients, they will be blinded to the other group. In the continuation of the treatment of the patients, in the diazepam group, this drug will be used with a dose of 10 mg, and in the diazepam (10 mg) + haloperidol (5 mg) group, this drug will be used. In the following, to evaluate the level of agitation, the evaluation of the level of sedation is used and its level is determined. 0 (exploratory trials) poisoned patients. Intervention 1: Intervention group: Diazepam (10 mg) + Haloperidol (5 mg). Intervention 2: Control group: Diazepam (10 mg). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts from the year 2024 To whom: Researchers working in academic and scientific institutions Conditions: People who are also engaged in pharmaceuticals and research Where to obtain: Peyman Erfan Talab Evini How to obtain: Administrative correspondence seven to ten working days Comments:
public Peyman Erfan Talab Evini
Kamali Street
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5102 5000 peyman1346erfan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Peyman Erfan Talab Evini
Kamali Street
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5541 9005 peyman1346erfan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria include consent to participate in the study, diagnosis of agitation with DSM 5 1 criteria following the consumption of stimulants and age over 18 years. 18 years no limit Both On the other hand, another set of indicators is considered as exclusion criteria, these exclusion criteria include lack of consent to participate in the study, the presence of risk factors for cognitive disorders such as the presence of brain and nerve diseases (such as seizures, dementia, Parkinson's). ), a history of moderate to severe head trauma, a history of head trauma, decreased level of consciousness, glaucoma, psychosis, moderate to severe dependence on other substances, heart diseases such as long QT 2, and observation of the side effects of the drugs used. F00-F99 F00-F99 Treatment - Drugs Treatment - Drugs Intervention group: Diazepam (10 mg) + Haloperidol (5 mg) Control group: Diazepam (10 mg) Agitation. Timepoint: 0,10,15,30 min. Method of measurement: richmond questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-11-19 Ethics committe of Shahid Beheshti University of Medical Sciences Velenjak Square, Daneshju Blv Tehran Tehran Iran (Islamic Republic of)