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IRCT20161022030421N3 IRCT 2019-06-15 Bagheiat-allah University of Medical Sciences Comparison of the effect of intravenous ketamine and midazolam as a premedication in children . Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents 2640-01-21 anticipated 74 Pending https://irct.ir/trial/39769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups of midazolam and ketamine. The person who codes the drug, for example, may will allocate even numbers to ketamine and odd numbers to midazolam, or vice versa, Blinding description: The medication will be prepared by a person in the volume of 5 cc and the drug code is written on it. Then another person who will not know the type of medicine will inject the drug into the child and fill out the questionnaire and record the drug code in the questionnaire.The child and parents will not be aware of the type of medicine. 3 Seduction of the chorus and dumb children. Intervention 1: Intervention group (Midazolam): In this group, midazolam will be given with dose of one tenth of mg / kg of midazolamole in a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation. Intervention 2: Intervention group (Ketamin): In this group, ketamine with dose of 1 mg per kg will be injected into a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation. Yes - There is a plan to make this available What will be shared: All data can be shared after unidentifiable people. When: Starting 1 month after publication To whom: People working in academic institute Conditions: For meta-analysis Where to obtain: by Email How to obtain: By sending a request to the University Vice-Chancellor for Research and obtaining a license Comments:
public Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street,Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Children from 6 months to 5 years of age with ASA class I and II, candidate for cochlear implant 6 months 5 years Both Children with known sensitivity to ketamine or midazolam, as well as history of taking psychiatric medications, age less than 6 months, increased ICP, brain tumor masses, history of seizure, upper and lower respiratory tract infection. Rehabilitation Rehabilitation Intervention group (Midazolam): In this group, midazolam will be given with dose of one tenth of mg / kg of midazolamole in a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation. Intervention group (Ketamin): In this group, ketamine with dose of 1 mg per kg will be injected into a 5-cc syringe and diluted into 5 cc distilled water. In pre-anesthetic room, the medicine will be injected intravenously, while the baby will be monitored for oxygenation. Sedation when separating from parents. Timepoint: In the pre-operative room, when the child is separated from the parents. Method of measurement: Observe and filling the form of sedation anxiety score scale (SASS). Sedation of the child during induction of anesthesia. Timepoint: On the operating room bed, Induction of anesthesia. Method of measurement: Using the form of sedation anxiety score scale (SASS). Child sedation in recovery. Timepoint: From the child's arrival to the recovery until the release of the recovery. Method of measurement: Using PACU sedation score scale (PACUSSS). Bagheiat-allah University of Medical Sciences Approved 2018-10-29 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Science, Mollasadra Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)