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IRCT2016101616106N2 IRCT 2016-12-27 Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences Efficacy of premedication with melatonin versus oral midazolam in pediartic patients Efficacy of premedication with melatonin versus oral midazolam in pediartic patients 2015-12-22 anticipated 23 Complete https://irct.ir/trial/15165 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 dental anxiety and management. Intervention 1: "Intervention group: Oral Melatonin tablet of 3 mg was grounded and added to 1cc of sweetened drinking water before being administered an hour prior to the actual IV sedation episode.". Intervention 2: "Control group: Oral Midazolam Vial of 5mg was added to 1cc sweetened drinking water before being administered half an hour prior to the actual IV sedation episode.".
public Afshin Zarghi
Vice Chancellor for Research
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9780 zarghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ghassem Ansari
Dept Pediatric Dentistry
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2225 5958 drgansari@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Uncooperative chidren aged 2-6 years, completely negative Frankel behavioral scale approved by two pediatric dentists, ASA I for systemic health with at least two teeth requiring treatments like pulpotomy, restoration, stainless steel crown or extraction for two separate dental visits. Exclusion criteria: Any systemic disease with contraindications for sedation or premedication, cold symptoms, nasal obstruction, respiratory infection, limited neck movement, macroglossia, tonsillar hypertrophy, micrognathia, mouth opening limitation, not being able to remain NPO and having less than two teeth requiring the same treatment. 2 years 6 years Both V Mental and behavioural disorders Treatment - Drugs Treatment - Drugs "Intervention group: Oral Melatonin tablet of 3 mg was grounded and added to 1cc of sweetened drinking water before being administered an hour prior to the actual IV sedation episode." "Control group: Oral Midazolam Vial of 5mg was added to 1cc sweetened drinking water before being administered half an hour prior to the actual IV sedation episode." Sedation. Timepoint: At the IV Administration step. Method of measurement: Houpt scale. Evaluation of recovery process and medication side effects. Timepoint: After the treatment ends and IV sedation reversed. Method of measurement: Observation and asking parents. Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences Approved 2016-06-21 Ethics Committee in Biomedical Research, Research Institute of Dental Sciences Shahid Beheshti Unive Office of Ethics, Research Institute for Dental Sciences, 5th floor,Dental school, Shahid Beheshti University of Medical Sciences, Student blvd, Evin Tehran Iran (Islamic Republic of)