]>
IRCT20180129038549N8 IRCT 2018-09-24 Esfahan University of Medical Sciences Reduction of agitation associated with ketamine Comparing the effect of intravenous midazolam and oral melatonin on controlling agitation caused by ketamine in emergency department 2017-06-22 anticipated 96 Complete https://irct.ir/trial/33561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the arrival of the patients to the emergency department, they are divided into 3 groups by a computer-generated random number table with 4 blocks, Blinding description: To make sure of the double-blind protocol of the study, preparation of the solutions, injections, and registration of the results were carried out by the pharmacology department. The packets were named A, B, and C following the codes. In one packet, there are intravenous midazolam and oral placebo, in the second packet, there is an equal volume of intravenous placebo and the oral melatonin, and in another packet, there is intravenous and oral placebo. Patients are randomized to receive one of the packets. The patients and their parents and the nurses are unaware of the contents of the drugs. Data collectors, outcome assessors, and data analysts are all kept blinded to the allocation. 3 Agitation. Intervention 1: Intervention group 1: In this group patients are receiving 0.05 mg/kg intravenous midazolam (slow infusion) and one placebo tablet, 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Intervention 2: Intervention group 2: In this group patients are receiving 0.3 mg/kg oral melatonin and 2 ml intravenous placebo (distilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Intervention 3: Control group: In this group patients are receiving one oral placebo tablet and 2 ml intravenous placebo (stilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mehdi Botshekan
Isfahan University of Medical Science, Hezarjrib Street, Isfahan CIty
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 saeedmajidinejad@yahoo.com Esfahan University of Medical Sciences scientific Saeed Majidinejad
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 saeedmajidinejad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years old Receiving ketamine as an anesthetic agent for small surgeries Patient's consent to participate in the study 18 years no limit Both Fever Obesity (BMI>30) Head trauma with loss of consciousness Brain tumor, Hydrocephaly Glaucoma Psychosis Psychological disorders History of using Benzodiazepine during last two weeks R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In this group patients are receiving 0.05 mg/kg intravenous midazolam (slow infusion) and one placebo tablet, 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Intervention group 2: In this group patients are receiving 0.3 mg/kg oral melatonin and 2 ml intravenous placebo (distilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Control group: In this group patients are receiving one oral placebo tablet and 2 ml intravenous placebo (stilled water), 30 minutes before receiving ketamine as an anesthesia. Thirty minutes after receiving this intervention, patients are receiving 1-2 mg/kg intravenous ketamine during 30-60 seconds and then receiving 0.25-0.5 mg/kg intravenous ketamine every 10 minutes as a maintenance dose (maximum 5 mg/kg). Richmond Agitation Scale score. Timepoint: Every 5 minutes after ketamine administration. Method of measurement: Richmond Agitation Scale table. Esfahan University of Medical Sciences Approved 2017-06-20 Ethics committee of Isfahan University of Medical Science Isfahan University of Medical Science, Hezarjrib Street, Isfahan City Isfahan Isfehan Iran (Islamic Republic of)