Nada Sunbul1, Mohamed Bilal Delvi2, Tariq Al Zahrani2, Fouad Salama3. 1. College of Dentistry, King Saud University, Riyadh, Saudi Arabia. 2. Department of Anesthesia, College of Medicine, King Saud University, Riyadh, Saudi Arabia. 3. Department of Pediatric Dentistry and Orthodontics, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. fsalama@ksu.edu.sa.
Abstract
PURPOSE: The purpose of this randomized, controlled, crossover clinical trial was to evaluate and compare the behavioral differences resulting from the sedative effects of atomized buccal (transmucosal) and atomized intranasal (parenteral) midazolam (0.3 mg/kg) as a method for sedation of pediatric dental patients. METHODS:Twenty-five36- to 72-month-old patients were randomly selected and divided into two groups that were sedated with either atomized buccal in the first visit or intranasal midazolam in the second visit (0.3 mg/kg). Patient be- havior was rated, and drug acceptance by method of administration was determined. RESULTS: There were no statistically significant differences between both groups in maximum working time. There were significant differences between both groups in drug acceptance (P=.008) and onset time (P=.00). The statistical differences between the two groups were not significant in all behavior rating scales, except for the crying rating scale, since the buccal group showed more crying. CONCLUSIONS: Atomized buccal and intranasal midazolam are both effective for sedation of pediatric dental patients and have the same maximum working time. However, atomized intranasal is more acceptable by children, has faster onset time, and children demonstrate less crying.
RCT Entities:
PURPOSE: The purpose of this randomized, controlled, crossover clinical trial was to evaluate and compare the behavioral differences resulting from the sedative effects of atomized buccal (transmucosal) and atomized intranasal (parenteral) midazolam (0.3 mg/kg) as a method for sedation of pediatric dental patients. METHODS: Twenty-five 36- to 72-month-old patients were randomly selected and divided into two groups that were sedated with either atomized buccal in the first visit or intranasal midazolam in the second visit (0.3 mg/kg). Patient be- havior was rated, and drug acceptance by method of administration was determined. RESULTS: There were no statistically significant differences between both groups in maximum working time. There were significant differences between both groups in drug acceptance (P=.008) and onset time (P=.00). The statistical differences between the two groups were not significant in all behavior rating scales, except for the crying rating scale, since the buccal group showed more crying. CONCLUSIONS: Atomized buccal and intranasal midazolam are both effective for sedation of pediatric dental patients and have the same maximum working time. However, atomized intranasal is more acceptable by children, has faster onset time, and children demonstrate less crying.