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IRCT20200720048146N1 IRCT 2020-10-04 Zahedan University of Medical Sciences Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients referring to emergency Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients 2020-10-22 anticipated 120 Complete https://irct.ir/trial/51375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: نمونه ها بر اساس شرایط ورود بیماران بصورت در دسترس از مراجعین به اورژانس بیمارستان خاتم الانبیاء ( ص ) زاهدان صورت خواهد گرفت و اختصاص به هر یک از دو گروه بصورت اختصاص تصادفی بلوک بندی شده با بلوک های ده تایی خواهد بود, Blinding description: After selecting patients for inclusion and exclusion criteria, drugs including midazolam 5mg or haloperidol 5mg are prepared by block randomization method. They are coded by the person in charge of the research, so that the doctor and the patient do not know the type of injectable drug. 1 Agitation. Intervention 1: Intervention group: Haloperidol 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28). Intervention 2: Control group: Midazolam 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public mohammad hossein Ajdari
Khatam Hospital Emergency
zahedan Iran (Islamic Republic of) 981777674 +98 54 3251 9517 mohamadhosenajdary1347zabol@gmail.com Zahedan University of Medical Sciences scientific mohammad hpssein Ajdari
Khatam Hospital Emergency
zahedan Iran (Islamic Republic of) 981777674 +98 54 3251 9517 mohamadhosenajdary1347zabol@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Includes age 15 to 60 years Class п ASA Ι Score above 28 on the agitation measurement scale 15 years 60 years Both Patient dissatisfaction (or legal partner) Unstable vital signs (blood pressure less than 90 mm Hg, heart rate below 60 and above 120 beats per minute, oxygen saturation level below 90%, level of consciousness less than agitation) History of heart disease and liver and kidney failure Pregnancy and lactation The patient is very restless and has the potential to harm himself and others and can not wait for a response to intramuscular injection of the drug. Poisoning with an unknown drug A history of active seizures requires medication Myasthenia Gravis Bone marrow suppression Patients with coagulation disorders such as hemophilia in whom intramuscular injection is contraindicated Thyrotoxicosis Hypersensitivity to midazolam or haloperidol R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Intervention group: Haloperidol 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28). Control group: Midazolam 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28). Agitation. Timepoint: The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, they are measured for drug response (agitation control) and at the end of two hours for side effects. Method of measurement: Drug response rate is defined according to the agitation measurement scale (score less than 28). Midazolam and haloperidol. Timepoint: At the beginning of the intervention. Method of measurement: Medications containing midazolam 5mg, or haloperidol 5mg, are prepared by block randomization. They are coded by the person in charge of the research, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. Zahedan University of Medical Sciences Approved 2020-01-05 National Ethics System in Biomedical Research Khatam Hospital Emergency Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)