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IRCT20180717040509N2 IRCT 2018-09-30 Mazandaran University of Medical Sciences Effect of Oral Midazolam and Ketamine in Pediatric Sedation Comparison of Oral Midazolam and Ketamine with Oral Midazolam and Promethazine in Pediatric Sedation 2014-11-22 anticipated 102 Complete https://irct.ir/trial/33419 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization, ASA Class, Blinding description: Patients are allocated randomly to groups by nurses. These patients will not know what group they are in. Also, the pharmacist, without the knowledge of the investigator, will encode the desired drugs. In this way, the investigator, doctor and nurse will also be unaware of the name of the drug they received. 3 Pediatric Sedation. Intervention 1: Intervention group: Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Ketamine (5mg/kg) from Gmbh ROTEXMEDICA, Germany mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose. Intervention 2: Control group:Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Promethazine (1 mg/kg) from Tehran Pharmaceutical Company mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Farzad Bozorgi
Amir Mazandarani Street
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 farzad722001@yahoo.com Mazandaran University of Medical Sciences scientific Farzad Bozorgi
Amir Mazandarani Street
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 farzad722001@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Pediatric between 2 to 10 years olds 2 years 10 years Both Children with Upper Respiratory Tract Infection Dissatisfaction to participate in the study Grade 3, 4, 5 or 6 of American Anesthesiology Association (ASA) Use of Sedative and Narcotic drugs Prohibited for Sedation Head Truama History of Cardiovascular Disease Eye Trauma History of Central Nervous System (CNS) Treatment - Drugs Treatment - Drugs Intervention group: Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Ketamine (5mg/kg) from Gmbh ROTEXMEDICA, Germany mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose Control group:Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Promethazine (1 mg/kg) from Tehran Pharmaceutical Company mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose Sedation. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Ramsay Sedation Scale. Pediatric's behavior. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Houpt Checklist. Crying Rate. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Houpt Checklist. Mazandaran University of Medical Sciences Approved 2014-11-19 Ethics Committee of Mazandaran University of Medical Science Moallem Square Sari Mazandaran Iran (Islamic Republic of)