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IRCT201301199162N8 IRCT 2016-03-30 Tehran University Of Medical Sciences Comparison of the effects and side effects of midazolam, haloperidol and the combination of them in agitated patients Comparison between the efficay of tranquillisation and side effects of midazolam, haloperidol and the combination of these two drugs on agitated patients in emergency rooms 2016-03-15 anticipated 126 Complete https://irct.ir/trial/9774 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 3 agitation. In this study drugs which are going to be prepared by the method of Block Randomization would be injected to patients with agitated behavior scale score of more than 28. Midazolam(5 miligram=1cc), haloperidol(5miligram=1cc) and the combination of midazolam (2.5 miligram) and haloperidol(2.5 miligram) with 2cc syringe will be injected intramusculry. In the next step, the patient's vital signs need to be documented and then drug will be injected.Patients will be under observed for 2 hours. Finally the response to the drug will be checked in an hour and also drug's side effects will be recorded after 2 hours..
public Atousa Akhgar
Poursina St. , Qods St. , Enghelab Avenue
Tehran Iran (Islamic Republic of) +98 21 6640 4377 At.akhgar@gmail.com Tehran University Of Medical Sciences scientific Amir Nejati
Poursina St. , Qods St. , Enghelab Avenue
Tehran Iran (Islamic Republic of) +98 21 6640 4377 Anejati@tums.ac.ir Tehran University Of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Exclusion criteria:Unstable vital signs( systolic blood pressure less than 90mmHg ,pulse rate less than 60 or more than 120/min and level of consciousness lower than agitation);past medical history of seizure;patients with unknown drug poisoning;Severe agitated patients who can not wait for the effect of intramuscular form of drugs;Allergy to midazolam and haloperidol; Closed angle glaucoma; Parkinson disease;Pregnancy and lactation; Myasthenia gravis;Thyrotoxicosis; Bone marrow suppression; Disagreement of patient's relatives on participation in the survey;Patients with coagulotion disorders such as hemophilia whom intramuscular injection is contraindicated; Reversible causes of agitation such as hypoglycemia (blood sugar less than 50),pain due to MI;Prolonged QT in patients ECG (QT >0.44) Inclusion criteria: 18 to 80 years old gitated patients with agitated behavior scale score of more than 28 . 18 years 80 years Both R45.1 Restlessness and agitation N/A In this study drugs which are going to be prepared by the method of Block Randomization would be injected to patients with agitated behavior scale score of more than 28. Midazolam(5 miligram=1cc), haloperidol(5miligram=1cc) and the combination of midazolam (2.5 miligram) and haloperidol(2.5 miligram) with 2cc syringe will be injected intramusculry. In the next step, the patient's vital signs need to be documented and then drug will be injected.Patients will be under observed for 2 hours. Finally the response to the drug will be checked in an hour and also drug's side effects will be recorded after 2 hours. Tranquilization(control of agitation). Timepoint: one hour after drug injection. Method of measurement: by physician with agitated behaviour scale. Side effects include:seizure ,extrapyramidal reactions:dystonia,akathisia,tardive dyskinesia,dizziness,neuroleptic malignant syndrom,nausea and vomiting,apnea or respiratory depression,pain in site of injection,cardiorespiratory arest. Timepoint: 30,60,120 min after drug injection. Method of measurement: physician 's examination and also checking vital signs. Tehran University Of Medical Sciences Approved 2015-08-23 tehran university of medical sciences tehran,bulvare keshavarz ,16azar avenue ,tehran unkversity of medical sciences, tehran Iran (Islamic Republic of)