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IRCT20230629058616N1 IRCT 2023-07-25 Shahid Beheshti University of Medical Sciences Evaluation of sedative effect of ketamine/midazolam with ketamine/dexmedetomidine in dental uncooperative children A comparative evaluation of sedative effect of intravenous ketamine/midazolam with ketamine/dexmedetomidine combination in 2-6 years old uncooperative pediatric dental patient 2023-08-06 anticipated 24 Complete https://irct.ir/trial/71046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Children selected to perform this clinical trial are randomly divided into two equal groups, in the first group (A) in one treatment session with the combination of intravenous ketamine/dexmedetomidine and in the next session with the combination of intravenous ketamine/midazolam under sedation. and in the second group (B) the order of prescribing the medicinal combination will be reversed. Two dental treatment sessions should be designed in such a way that they are similar and comparable in terms of the type and duration of treatment. The combination of studied drugs is also prepared by the anesthesiologist and prescribed to the patient during the treatment and according to the protocol, Blinding description: The patients and the therapist are not aware of sedative medication regimen during dental procedures. The anesthesiologist and the care team will only be aware about that. 3 َAnxiety. Intervention 1: Intervention group: In group AB, combination of Dexmedetomidine (dose: 1μgr/kg) and ketamine (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. Propofol injection will continue (dose: 150μgr/kg/H) for sedation maintenance. Intervention 2: Control group: In group BA, combination of Ketamine (dose: 2mgr/kg) and Midazolam (dose: 0.2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. 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 further information
public Seyed Masoud Seyed Ahadi
Shahid Beheshti Dental School, Daneshjo Blvd, Evin, Tehran, Iran
tehran Iran (Islamic Republic of) 1983963113 +98 21 2241 3897 dr.masoud.ahadi@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Masoud Seyed Aadi
Shahid Beheshti Dental School, Daneshjo Blvd, Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2240 3080 dr.masoud.ahadi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Non-cooperative children aged 2-6 years (completely negative based on the Frankel scale rating) The patient should be in ASA I group. The patient needs to perform at least 2 sessions of similar dental work and needs injection. 2 years 6 years Both Do not have a systemic disease. Do not be in ASA1, ASA2 groups. .Do not have contraindications to receive sedatives. During sedation, they should not have symptoms of cold or respiratory tract obstruction F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: In group AB, combination of Dexmedetomidine (dose: 1μgr/kg) and ketamine (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. Propofol injection will continue (dose: 150μgr/kg/H) for sedation maintenance Control group: In group BA, combination of Ketamine (dose: 2mgr/kg) and Midazolam (dose: 0.2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. The level of child's cooperation. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Observation and based on Houpt Behavioral Scale. Heart Rate. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device. Atrial oxygen saturation or Spo2. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device. Research Assistant of Shahid Beheshti University of Medical Sciences Approved 2023-06-10 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti Dental School, Daneshjoo Bvld, Shahriyari sq, Evin, Chamran Highway, Tehran-Iran tehran Tehran Iran (Islamic Republic of)