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) seda-tion of midazolam (MDZ) in compare to dexmedetomidine (DEX) while taking into consid-eration the effect of dental fear, and psychological status on sedation success. Materials and Method: This double-blind randomized clinical trial included 92 uncoopera-tive 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 ques-tionnaire (SDQ). Data were analyzed using T-test, Mann-Whitney, Chi-square, and repeat-ed-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). Howev-er, 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 re-mained within normal limits in both groups. Conclusion: Sedation with IN MDZ resulted in overall behaviors, which were more satis-factory 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.