Comparison of the Onset of Action and Behavioral Responses to Intranasal and Sublingual Routes of Midazolam Sedation in Children - A Randomized Controlled Trial

Young children with serious oral illnesses and non complianceoften test the patience and skills of the Pediatric dentists.Children aged 3 to 7 years with severe pain and pathology aremore anxious and have difficulty in communicating properlyto the dentist . Pain and the treatment procedures assuch influencethe behavior of the children in the dental office.These children require local anesthetic drug administration to alleviate the pain. The reaction of the child to local anesthetic drug administration can be a sign of emerging perception which further affects the behavior of the children in the dental office. Pharmacologic behavior management might be needed to manage them. Moderate sedation as described by American Academy of Pediatric Dentistry (AAPD) refers to drug induced depression of consciousness during which patients respond purposefully to verbal commands. Transmucosal sedation has gained a lot of importance in pediatric dentistry in the last decade. The term transmucosal means “through, or across a mucous membrane”. Transmucosal drug delivery system includes drugs administration through rectal, intranasal and sublingual routes. These routes offer a rapid onset and bypass  first pass metabolism. Being non invasive, these routes can be child friendly. Among the medications available, midazolam has gained a lot of attention as a good pediatric sedative

agent in the recent years. It is a short acting benzodiazepine with rapid onset, faster recovery, anxiolytic and anterograde amnestic effects. The rapid onset of midazolam makes it an ideal sedative agent to be used in dental office as a sedative agent. Recent studies have shown that intranasal and buccal routes have also been used as alternative routes for midazolam administration. There

is limited literature in the use of sublingual midazolam sedation in pediatric dentistry. Hence this study was planned to assess the onset of action and behavior of the children after intranasal and sublingual midazolam sedation.

A randomized controlled trial was planned and the study protocol was approved by the Institutional Review Board, KSR Institution of Dental Science and Research, (KSRIDSR) Tiruchengode, Tamil Nadu. Ethical clearance was obtained. The study followed the principles for medical research involving human subjects described by Helsinki declaration. Sample size was calculated based on the work of Shashikran et al. with type I error 5% and power of test 80% and it was calculated to be 36. Hence 48 apprehensive children who reported to the Department of Pedodontics and Preventive dentistry, KSRIDSR during the study period (August 2013 to August 2014) and who needed treatment under sedation were selected for the study.