COMPARATIVE EVALUATION OF ONSET, DURATION AND SAFETY BETWEEN MIDAZOLAM, DEXMEDETOMIDINE SEDATION AND THEIR COMBINATION IN PRESCHOOLERS: A RANDOMIZED CLINICAL TRIAL

Abstract

Introduction: Dental anxiety is a global problem in pediatric dentistry. Moderate sedation is an acceptable option for uncooperative preschoolers dental patients. Objective: To compare midazolam (MDZ), dexmedetomidine (DEX) and their combination (DEX/MDZ) as sedative drugs for preschoolers undergoing dental treatment regarding onset, duration and safety of sedation. Materials and methods: The study was a three-arm randomized clinical trial with a parallel design. Seventy-two healthy uncooperative preschoolers were selected from the Faculty of Dentistry, Alexandria University, Egypt. The participants were randomly allocated into, control group received 0.5mg/kg MDZ, study group I received 5µg/kg DEX, and study group II received 0.3mg/kg MDZ followed by 3µg/kg DEX. Each child received quadrant treatment. Time until optimum sedation and recovery were recorded. Vital signs were recorded throughout the treatment session. Results: All children were comparable regarding demography, physical status and baseline vital signs (blood pressure, heart rate, and oxygen saturation). There was a statistically significant difference regarding onset and duration of the effect of sedative drugs (P=<0.001). Dexmedetomidine had the most delayed onset of action (17.08 ± 5.88 min), while DEX/ MDZ had the longest duration of action (68.13 ± 17.12). There was a significant decrease in blood pressure throughout the sedation session for all children. Children who were sedated with DEX and DEX/MDZ had a significant decrease in heart rate than children sedated with MDZ. No statistically significant effect of drugs on oxygen saturation levels was recorded. Conclusion: Midazolam, Dexmedetomidine and their combination are safe drugs during moderate sedation for children undergoing dental treatment.