BACKGROUND: We prospectively assessed the efficacy and side effects of four sedation techniques in our dental clinic: oral midazolam, intranasal (IN) midazolam, IN midazolam combined with oral transmucosal fentanyl citrate (OTFC), and IN midazolam combined with IN sufentanil. MATERIALS & METHODS: With IRB approval, a nonrandomized open label study of moderate sedation in children undergoing dental surgery was administered during a 6 -month period. The sedation regimen was rotated daily at the anesthesiologist's discretion. Each sedation was monitored by a research nurse who assessed the quality of sedation and the frequency of complications. All children were monitored during the procedure and recovery for at least 20 min, before discharge based on the University of Michigan Sedation and Ohio State behavior rating scores. RESULTS:One hundred and two children were sedated in the dental clinic during this period. The sedation was successful in 73% (range 64% to 88%) of the children. The time to onset was greatest with OTFC (37 min) and least with IN midazolam (17 min) compared with the other two groups (20 and 30 min). Recovery after OTFC was prolonged (39 min) significantly compared with the other three groups (26.5-30 min). Efficacy of sedation and frequency of complications (9% incidence of nausea and 6% of mild hemoglobin desaturation) were similar among the groups. CONCLUSIONS: All four sedation regimens were equally effective in this cohort of healthy children. The onset and recovery with OTFC was significantly delayed compared with the other regimens. The frequency of side effects was small; there were no side effects in the PO midazolam group.
RCT Entities:
BACKGROUND: We prospectively assessed the efficacy and side effects of four sedation techniques in our dental clinic: oral midazolam, intranasal (IN) midazolam, IN midazolam combined with oral transmucosal fentanyl citrate (OTFC), and IN midazolam combined with IN sufentanil. MATERIALS & METHODS: With IRB approval, a nonrandomized open label study of moderate sedation in children undergoing dental surgery was administered during a 6 -month period. The sedation regimen was rotated daily at the anesthesiologist's discretion. Each sedation was monitored by a research nurse who assessed the quality of sedation and the frequency of complications. All children were monitored during the procedure and recovery for at least 20 min, before discharge based on the University of Michigan Sedation and Ohio State behavior rating scores. RESULTS: One hundred and two children were sedated in the dental clinic during this period. The sedation was successful in 73% (range 64% to 88%) of the children. The time to onset was greatest with OTFC (37 min) and least with IN midazolam (17 min) compared with the other two groups (20 and 30 min). Recovery after OTFC was prolonged (39 min) significantly compared with the other three groups (26.5-30 min). Efficacy of sedation and frequency of complications (9% incidence of nausea and 6% of mild hemoglobin desaturation) were similar among the groups. CONCLUSIONS: All four sedation regimens were equally effective in this cohort of healthy children. The onset and recovery with OTFC was significantly delayed compared with the other regimens. The frequency of side effects was small; there were no side effects in the PO midazolam group.