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IRCT20140106016106N6 IRCT 2020-11-25 Shahid Beheshti University of Medical Sciences Comparing sedation effect of IV Ketamine with Fentanyl in pediatric dentistry KFST Comparing the sedative effect of IV Ketamine/Midazolam and Fentanyl/ Midazolam in uncooperative pediatric dental patients 2017-11-10 anticipated 38 Complete https://irct.ir/trial/29829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In order to Assess the sequence effect on patient's behavior, all participats will randomly assigned to one of the two groups with group I receive experimental drug combination (Fentanyl Atropin Midazolam) at the first visit and Control drug combination (Ketamine Atropine Midazolam) at the second visit while the second group will receive the same drugs in opposite order. A computerized randomized numbering will be used for allocation for the two groups, Blinding description: Appropriate doses of case and Control Drugs are prepared in separate syringes labeled with coding of A or B by anesthesiologist who injects them based on the protocol. The operator (researcher) and the evaluators have no clue of the type and dose of that given drug while treatment is underway and only able to observe the coded drug at every session. 3 Uncooperative Pediatric Dental patient. Intervention 1: Intervention group: Receiving the drug combination of 2 µg/kg Fentanyl, 0.2 mg/kg Midazolam, 0.1mg/kg Atropine IV at the case session scheduled using an IV line on top of oxygen line connected to patient's nose. while all vital signs are checked and recorded before injection, at start and in every 15 minute intervals. Intervention 2: Control group: Receiving the drug combination of 0.3 mg/kg Fentanyl, 0.2 mg/kg Midazolam, 0.1mg/kg Atropine IV at the control session scheduled using an IV line on top of oxygen line connected to patient's nose. while all vital signs are checked and recorded before injection, at start and in every 15 minute intervals. Yes - There is a plan to make this available What will be shared: Raw Data for Fentanyle Project When: A year and half after publication To whom: Future Fellowship Residents Conditions: Taking a view as well as cotrolling the accuracy Where to obtain: Dr Ghassem Ansari How to obtain: Presenting a request to the Vice chancelor for research at Shahid Beheshti University of Medical Sciences Comments:
public Dr Ghassem Ansari
Department of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin,
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 9421 drgansari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Ghassem Ansari
Dept of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin, Chamran High Way
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 9421 drgansari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Uncooperative Children aged 2 to 6 years (definitely negative in Frankl scale) Patients needing at least 2 similar dental treatment sessions with local anesthesia. pediatric patients in ASA I 2 years 6 years Both Patients with any Systemic disease, Patients having common cold at treating session any contraindication for the use of drugs or sedation F41.1 Generalized anxiety disorder Treatment - Drugs Treatment - Drugs Intervention group: Receiving the drug combination of 2 µg/kg Fentanyl, 0.2 mg/kg Midazolam, 0.1mg/kg Atropine IV at the case session scheduled using an IV line on top of oxygen line connected to patient's nose. while all vital signs are checked and recorded before injection, at start and in every 15 minute intervals. Control group: Receiving the drug combination of 0.3 mg/kg Fentanyl, 0.2 mg/kg Midazolam, 0.1mg/kg Atropine IV at the control session scheduled using an IV line on top of oxygen line connected to patient's nose. while all vital signs are checked and recorded before injection, at start and in every 15 minute intervals. Induced sufficient sedation for delivering dental treatment. Timepoint: baseline, at IV sedation, every 15 min afterwards, at discharge. Method of measurement: Recording data in prepared forms in addition to a questionnaire. Adverse effects of the sedative drugs used. Timepoint: at discharge and 24 hours later. Method of measurement: Questionnaire and by phone. Shahid Beheshti University of Medical Sciences Approved 2018-10-14 ethics committee of Shahid Beheshti University of Medical Scienses Dental Research Institute, Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin, Chamran High Way, Tehran Tehran Iran (Islamic Republic of)