Comparison of intranasal midazolam and dexmedetomidin premedication effect on 2-6 years old uncooperative children behavior in dentistry

The aim of this study is comparison effect of intranasal midazolam and dexmedetomidine on 2-6 years old children behavior in pediatric dentistry. This cross-over double blind randomized controlled trial is carried on twenty 2-6 years old children reffered to dental school based on inclusion criteria: Healthy according ASA1 classification; uncooperative negative and definitely negative as frankl scale; having at least 2 sessions dental work and exclusion criteria: Cold; tonsils hypertrophy; severe obesity. After obtaining written informing consent, written and orally instructions before conscious sedation, at first meeting the first group receives 0.2 mg/kg Midazolam intranasal(Regimen A) and the second group receives 1 µg/kg Dexmedetomidine intranasal(Regimen B). In the second session, the first group receive regimen B and the second group B receives regimen A. After 20 minutes premedication every patient receives 0.1 mg/kg Midazolam and 1-2 mg/kg Ketamine and 0.25 mg Atropine intravenously. Dental treatment starts with lidocaine 2% with adrenaline 1/80000 anesthesia by a pedodontist who is blind to type of regimen. Sedation level and the child's behavior based on Houpt scale evaluates by a member of teamwork who does not aware of the type of regimen. Arterial blood oxygen saturation (SpO2), heart rate (HR) and blood pressure before administration, starting, every 15 minutes during the work, after work and discharge patients records in related form.

All costs of the project is paid by Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences Tehran, Iran.