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IRCT20140106016106N7 IRCT 2020-11-30 Shahid Beheshti University of Medical Sciences Evaluation of sedative effect of ketamine/fentanyl and midazolam/fentanyl on dental uncooperative children Comparison of sedative effect of intravenous Ketamin/Fentanyl with Midazolam/Fentanyl on 2-6 years old uncooperative pediatric dental patients 2019-04-08 anticipated 30 Complete https://irct.ir/trial/51692 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 be assigned into one of the two groups, with group I receiving experimental drug combination (Fentanyl Atropin Midazolam) at the first visit and Control drug combination (Ketamine Atropine Fentanyl ) at the second visit while the second group will receive the Control drug combination (Ketamine Atropine Fentanyl ) at the first visit and experimental drug combination (Fentanyl Atropin Midazolam) at the second visit in opposite order. A table of randomization of numbers will be used for allocation of samples for the two groups, Blinding description: Preparation of experimental and control drugs into previously coded syringes are performed by the anesthesiologist in charge. In this line the operator (researcher) and the two judging evaluators do not have any clue of the content of the syringes. 3 Uncooperative Pediatric Dental patient. Intervention 1: Intervention group: Receiving the drug combination of Fentanyl1-2 µg/kg micrograms , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg IV in one of the two randomize assigned and scheduled visits using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals. Intervention 2: Control group: Receiving the drug combination of Fentanyle1 to 2 µg/kg , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg in one of the two randomly assigned scheduled visits by randomization table using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals during treatment. Yes - There is a plan to make this available What will be shared: Raw Data for Fentanyl Ketamine 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) Children aged 2 to 6 years Patients needing at least 2 similar dental treatment sessions ،treating each tooth requires local Anesthesia. pediatric patients in ASA I Uncooperative child definitely negative (in Frankl scale) 2 years 6 years Both Patients with any Systemic disease Patients having common cold at treating session any contraindication for the use of drugs any contraindication for the use of sedation Drug Allergy F41.1 Generalized anxiety disorder Treatment - Drugs Treatment - Drugs Intervention group: Receiving the drug combination of Fentanyl1-2 µg/kg micrograms , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg IV in one of the two randomize assigned and scheduled visits using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals. Control group: Receiving the drug combination of Fentanyle1 to 2 µg/kg , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg in one of the two randomly assigned scheduled visits by randomization table using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals during treatment. 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 2020-02-15 Ethics committee of Shahid Beheshti University of Medical Sciences Dental Research Institute, Dental School , Shahid Beheshti University of Medical Sciences, Students Blvd ,Evin ,Chamran High Way Tehran Tehran Iran (Islamic Republic of)