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IRCT20230612058465N1 IRCT 2023-06-18 Mashhad University of Medical Sciences Ketamine effectiveness for acute agitation Comparison of the effectiveness and side effects of ketamine and haloperidol in controlling acute delirium and acute agitation 2023-06-28 anticipated 120 Complete https://irct.ir/trial/70669 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups based on a table of random numbers, and the name of the prescribed drug is placed inside an envelope in a package. The colleague nurse opens the envelope, prescribes the drug, and then writes the number of the envelope on a checklist which is later completed by the emergency medicine assistant. Then the medical assistant will evaluate the patient and at the end, the envelopes are opened and the prescribed drug for each patient is determined and the data is analyzed. The researcher and medical assistant are blinded in this study, Blinding description: In this study, the researcher and the assessor, who is an emergency medicine assistant, are blinded to the drug prescribed by the nurse colleague in the study. At first, based on the table of random numbers, the number and type of prescribed drug is placed in an envelope, the colleague nurse administer the drug without the researcher's accompaniment and records the number of the envelope in the checklist, then the medical assistant evaluated the patient. Finally, after the end of the study, the envelopes are opened and the prescription drug in each checklist is determined and the data are analyzed. 3 Acute agitation. Intervention 1: Intervention group: Ketamine Group. Intervention 2: Intervention group: Haloperidol group. Yes - There is a plan to make this available What will be shared: All data can be shared after the completion of the study and after the approval of the ethics committee of the university. When: immediately after acceptance of the manuscript. To whom: All researchers of academic centers. Conditions: For further investigation Where to obtain: Elnaz Vafadar Moradi MD. How to obtain: You can E-mail me and tell me the reason for requesting the data, I will send to request to ethics committee, and if they approved, I will send the data. Comments:
public Elnaz Vafadar Moradi
Razi squ.
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3852 5312 VafadarME@mums.ac.ir Mashhad University of Medical Sciences scientific Elnaz Vafadar Moradi
Razi squ.
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3852 5312 Vafadarme@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All acutely agitated patients enrolled in the study. Treatable causes such as hypoxia and hypoglycemia were evaluated in if present, treated. 18 years 85 years Both Any sensitivity to ketamine or haloperidol, past medical history of dissection or myocardial infarction, or QT prolongation lead to exclude from the study. agitation Restlessness and agitation Treatment - Drugs Treatment - Drugs Intervention group: Ketamine Group Intervention group: Haloperidol group Agitation control based on RASS score. Timepoint: After admission, 30 and 60 minutes after the drug administration. Method of measurement: Agitation control will be assess by Richmond Agitation and Sedation Score. The sedation time based on minutes, the side effects of drugs include apnea, nausea and vomiting, need for intubation, tachycardia, hypertension, tachycardia, QT prolongation, tachycardia, and dysrhythmias. Timepoint: At admission and 30 and 60 minutes after drug administration. Method of measurement: Any side effects and time to sedation(minutes) will document. Mashhad University of Medical Sciences Approved 2023-05-01 Research Ethic committee of Imam Reza Hospital, Research and Treatment center-Mashhad University of Razi squ. Mashhad Razavi Khorasan Iran (Islamic Republic of)