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IRCT20120130008872N13 IRCT 2019-10-23 Tehran University of Medical Sciences Haloperidol midazolam versus ketamine midazolam in agitated patients Comparison of the efficacy of haloperidol combination with midazolam versus haloperidol ketamine in patients with agitation in emergency room 2019-11-20 anticipated 70 Complete https://irct.ir/trial/43026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patient in order of arrival with a randomization software allocated individually in to separate groups. sample size is 70 and the range of numbers are 1 to 70 and each number belong only to one patient and do not repeat. one group receive midazolam and haloperidol and the other on will receive haloperidol and ketamine, Blinding description: Researcher allocated the patient to each group( A or B ) in according the arrival time and specific number and then the nurse deliver drugs to the patient. Patients are blinded to type of drugs. Checklist fill by a person who is blinded to type of delivered drug. Data analyzer is also blinded to the type of drug because he or she is blinded to the type to drugs that delivered to group A and B. N/A agitation. Intervention 1: Intervention group: A Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention haloperidol. Intervention 2: Control group: B will receive 2.5 mg haloperidol iv and 0.5 mg/kg iv ketamine. Yes - There is a plan to make this available What will be shared: The raw data and coded information of the patients participating in the study can be provided When: In the end of the study and after publication of the results the data will be available and we have plan to preserve data for 10 years To whom: Person with academic position Conditions: In order to conduct and design future study in this field Where to obtain: email contact with Mr. Morteza Saeedi; m_saeedi@tums.ac.ir How to obtain: After confirmation of applicant identity, we will contact him/her by email Comments:
public Morteza Saeedi
Shariati Hospital, North Amirabad street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2719 m_saeedi@tums.ac.ir Tehran University of Medical Sciences scientific Morteza Saeedi
Shariati Hospital, North Amirabad street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2719 m_saeedi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All agitated patients above 18 years old and admitted to emergency ward 18 years no limit Both Pregnant women age<18 y sever head trauma suspected ICP rising seizure history unwilling to participation in the study hypoglycemia hypoxemia all conditions that have treatable medical condition as a reason for agitation agitation Treatment - Drugs Treatment - Drugs Intervention group: A Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention haloperidol Control group: B will receive 2.5 mg haloperidol iv and 0.5 mg/kg iv ketamine Agitation level. Timepoint: Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention. Method of measurement: altered mental scale score(AMSS). Spo2. Timepoint: Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention. Method of measurement: pulsoxymerer. Respiratory Rate. Timepoint: Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention. Method of measurement: numbers per min. Blood pressure. Timepoint: Before intervention and 5, 15, 30, 90, 120 min and 4 hours after intervention. Method of measurement: mmhg. Tehran University of Medical Sciences Approved 2018-11-10 Tehran University of Medical Sciences, School of Medicine Poursina Street, 16 Azar Street, Bolvar Keshavarz Ave. Tehran Tehran Iran (Islamic Republic of)