Comparison of two Intranasal Sedatives, Midazolam versus Dexmedetomidine, in Children with High Dental Fear: a Randomized Clinical Trial

STATEMENT OF THE PROBLEM: Pharmacologic management of uncooperative behavior is a growing trend in dentistry. Determining the most appropriate drug, route of administration, and proper candidate for sedation have been the goal of several investigations. PURPOSE: The aim of this study was to compare the sedative effect of intranasal (IN) sedation of midazolam (MDZ) in compare to dexmedetomidine (DEX) while taking into consideration the effect of dental fear, and psychological status on sedation success. MATERIALS AND METHOD: This double-blind randomized clinical trial included 92 uncooperative dental patients aged 4-6. Study participants were randomly assigned to receive either 0.2mg/kg IN MDZ or 1µg/kg DEX. Sedation was evaluated using the Houpt sedation rating scale. Vital signs were recorded before and during sedation. Prior to sedation, the level of dental fear was determined through children's fear survey schedule-dental subscale (CFSS-DS). Psychological characteristics were screened using the strengths and difficulties questionnaire (SDQ). Data were analyzed using T-test, Mann-Whitney, Chi-square, and repeated-measures analysis of variance (ANOVA). RESULTS: Overall ratings of sedation and subscales of sleep, crying, and movement were comparable between groups (p> 0.05); however, more acceptable behavior (overall scores (4+5+6) was observed in MDZ group compared to DEX group (64% vs. 47.7%) (p= 0.007). All participants were found to have abnormal levels of dental fear (CFSS-DS≥38). However, according to SDQ, the study participants have mainly shown normal behavioral status. A significant association was found between dental fear and sedation success (MDZ, p= 0.001, DEX, p= 0.03), while similar findings were not observed for psychological characteristics (MDZ, p= 0.09 and p= 0.41; DEX, p= 0.71 and p= 0.53). Physiological parameters remained within normal limits in both groups. CONCLUSION: Sedation with IN MDZ resulted in overall behaviors, which were more satisfactory in highly fearful pediatric dental patients. Despite baseline uncooperative behaviors, the psychological status of study participants were close to average and were not associated with sedation failure.