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. OBJECTIVES: 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 MERTHODS: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. CONCLUSIONS:Midazolam, Dexmedetomidine and their combination are safe drugs during moderate sedation for children undergoing dental treatment. The protocol of the study was registered and posted on the ClinicalTrials.gov public website. ClinicalTrials.gov Identifier: NCT03827408.