A Double-Blind Clinical Trial to Determine the Effect of Oral Zolpidem and Midazolam on the Level of Preoperative Anxiety in Children Undergoing Eye Examination Under General Anesthesia

Abstract

Background: Preoperative anxiety is a very important factor in pediatric surgery; 40% - 60% of children experience a high level of anxiety in the preoperative period. Objectives: Given the need for anxiety control in children and considering that limited studies have been conducted in this regard, this research was performed to compare the effect of oral zolpidem and midazolam on level of preoperative anxiety in children. Methods: In a prospective double-blind randomized controlled trial, 56 cases were randomly divided into two groups of 28 participants. A group underwent zolpidem premedication and the other underwent midazolam premedication. The level of preoperative and postoperative anxiety was measured by MYPAS SCORE checklist and compared. Results: The study comprised 56 patients (19 girls and 37 boys) aged between 3 - 9 years. The mean score of anxiety in the group receiving midazolam was 63.80 in pre-test and 32.61 in post-test (P < 0.001). The mean score of anxiety in the group receiving zolpidem was 62.49 in pre-test and 30.94 in post-test (P < 0.001). Mean anxiety in the patients of zolpidem group was lower than that in midazolam group (P < 0.001). Conclusions: Our results show that both zolpidem and midazolam reduce preoperative anxiety, however, the preoperative anxiety was significantly decreased after taking zolpidem in comparison with midazolam. Zolpidem is a hypnotic drug with rapid onset and short duration of action, which might be an alternative premedication for midazolam in pediatric anesthesia, particularly when the reduced anxiety and child cooperation are needed.