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IRCT20210904052371N2 IRCT 2021-10-26 Mazandaran University of Medical Sciences The comparison sedation effect of intranasal ketamine and midazolam in premedication of child herniorrhaphy surgery The comparison sedation effect of intranasal ketamine and midazolam in premedication of child herniorrhaphy surgery 2021-10-17 anticipated 36 Complete https://irct.ir/trial/59075 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment process is blockade and the Random Allocation software used to block 6 blocks of 6 has been created. Both drugs are colorless and the nurse in charge of preparing the drugs in syringes A and B fills in the anesthesia assistant according to the randomization block. Random letters A and B are injected into the child without knowing the type of medicine, and also the person who performs sedation and analgesia and evaluates the child's behavior is completely unaware of the type of medicine. Then the person doing the sedation and pain assessment and assessing the child's behavior was also completely unaware of the type of medication, Blinding description: For bilateral blindness, patients are divided into two groups of 18 people. Half an hour before the procedure, one group of midazolam (0.5 mg / kg) intranasal and the other group of ketamine (5 mg / kg) intranasal in the syringe without the name of the drug is prescribed. Becomes. The degree of sedation, behavioral assessment, heart rate, ease of separation from parents and their satisfaction are reviewed and recorded. 3 The degree of sedation of the drug. Intervention 1: Intervention group: Midazolam (0.5 mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness. Intervention 2: Intervention group:Ketamine (5mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness. 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 Hamidreza Efati
Amir Mazandarani St., Imam Khomeini Hospital, Sari
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 hamidrezaefati5@gmail.com Mazandaran University of Medical Sciences scientific Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age range 1 to 6 years Physical condition according to the American Society of Anesthesia 1 or 2 (ASA PA) Having the informed consent of the parents to participate in the study Patients who have a history of sedative or analgesic use in the past 24 hours Patients with normal liver enzymes Patients who are normal in terms of psychological diseases They have no food or medicine allergies 1 year 6 years Both Allergy to any of the drugs used in premedication or during surgery Having any hemodynamic disorders People who have respiratory problems during surgery and irritable upper airway disease such as colds Parental dissatisfaction Y47 Sedatives, hypnotics and antianxiety drugs Treatment - Drugs Treatment - Drugs Intervention group: Midazolam (0.5 mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness. Intervention group:Ketamine (5mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness. Relaxation. Timepoint: The beginning of anesthesia until the end of anesthesia. Method of measurement: Ramsay Sedation Scale. Behavioral evaluation. Timepoint: The beginning of anesthesia until the end of anesthesia. Method of measurement: Visual Analogue Scale. Heart beat. Timepoint: The beginning of anesthesia until the end of anesthesia. Method of measurement: monitor. Ease of separation from parents. Timepoint: The beginning of anesthesia until the end of anesthesia. Method of measurement: Visual Analogue Scale. Nausea and vomiting. Timepoint: End of Anesthesia Tick hours after anesthesia. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2021-09-29 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)