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IRCT201101181861N2 IRCT 2011-04-30 Dental Research Center, Shahid Beheshti Dental School Comparison of Meperidine versus Midazolam Sedation in Uncooperative children A Comparison of 2 Oral Sedation Regimens: Hydroxyzine-Midazolam and Hydroxyzine -Meperidine with oral Hydroxyzine-submucosal Meperidine in Dental Sedation of uncooperative 2-6 years of age children 2010-05-24 anticipated 78 Complete https://irct.ir/trial/1460 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive. 2-3 Anxiety. Intervention 1: InterventionGroup B (Midazolam-Hydroxyzine): in this group, Hydroxyzine is administered with a dose of 1mg/kg at first, after 30 minutes Midazolam (0.5 mg/kg in mixture with the same volume of 10% sugar syrup) will be administered to the patient by cup and under the supervision of anesthesiologist. In the case of uncooperation, the drug will be poured in the lower buccal vestibule by a syringe.Treatment will begin after 30 minutes. Intervention 2: Intervention group C (Oral Meperidine-Hydroxyzine): in this group both meperidine (2mg/kg) and hydroxyzine (1mg/kg) are administered simultaneousnessly 1 hour before treatment. Intervention 3: Control Group (submucosal injection of meperidine-Hydroxyzine): in this group, Hydroxyzine (1mg/kg) is administered one hour before treatment. After 30 minutes of hydroxyzine administration, meperidine (1mg/kg) will be injected slowly in upper vestible between canine and first molar (11) at the opposite site of dental. The main treatment will be begun in half an hour.
public Ms Asgari
Department of Research in Dental Sciences, Dental School, Daneshjoo blvd, Evin
Tehran Iran (Islamic Republic of) 19432 +98 21 2240 3010 Iceberg2008@yahoo.com Shahid Beheshti Dental school scientific Katayoun Salem
Dental School, Imam Blvd
Rasht Iran (Islamic Republic of) 19871 +98 13 1322 0060 k_salem@gums.ac.ir , katayoun.salem@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age between 2-6 years; Behavior: Negative or completely negative according to Frankl rating scale; Health status: ASA I; should have at least 3 consecutive similar treatment sessions. Exclusion criteria: history of allergic reactions to Benzodiazepines or any other drug used in the study; Previous complications with general anesthesia in patient or family; Hyper trophic adenoids in a manner that occupied more than 50% of pharyngeal space (Brodsky 2+>); Sleep apnea. 2 years 6 years Both F93.1 Phobic anxiety disorder of childhood Treatment - Drugs Treatment - Drugs Treatment - Drugs InterventionGroup B (Midazolam-Hydroxyzine): in this group, Hydroxyzine is administered with a dose of 1mg/kg at first, after 30 minutes Midazolam (0.5 mg/kg in mixture with the same volume of 10% sugar syrup) will be administered to the patient by cup and under the supervision of anesthesiologist. In the case of uncooperation, the drug will be poured in the lower buccal vestibule by a syringe.Treatment will begin after 30 minutes. Intervention group C (Oral Meperidine-Hydroxyzine): in this group both meperidine (2mg/kg) and hydroxyzine (1mg/kg) are administered simultaneousnessly 1 hour before treatment Control Group (submucosal injection of meperidine-Hydroxyzine): in this group, Hydroxyzine (1mg/kg) is administered one hour before treatment. After 30 minutes of hydroxyzine administration, meperidine (1mg/kg) will be injected slowly in upper vestible between canine and first molar (11) at the opposite site of dental. The main treatment will be begun in half an hour. Sleepness. Timepoint: Once(at the beginning of the treatment). Method of measurement: Observation. Movement. Timepoint: During the process of treatment. Method of measurement: Observation. Crying. Timepoint: During the process of treatment. Method of measurement: Observation. Overall behavior. Timepoint: During the process of treatment. Method of measurement: Observation. Fear of Dentistry. Timepoint: Before treatment and after the final session. Method of measurement: questionnaire. Recovery time. Timepoint: After treatment completion. Method of measurement: Observation. Respiratory Rate. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring. Blood Pressure. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring. Oxygen Saturation. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring. Adverse reactions. Timepoint: During and after treatment. Method of measurement: Observation. Dental Research Center, Shahid Beheshti Dental School Approved 2011-03-13 Research Center of Dental Sciences, Shahid Beheshti University of Medical Sciences 4th floor, Dental School, Daneshjoo Boulevard, Evin Tehran Iran (Islamic Republic of)