Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross.over, clinical trial

MATERIALS AND METHODS Study design The study was designed as a randomized, double-blind, cross-over clinical trial (registered in www.clinicaltrial.gov with the code NCT01118884) on 18 children (totally 36 clinical sessions) aged 3-6 years who were rated as Category 1 or 2 on the Frankl behavior rating scale, which means showing negative or definitely negative behavior. The exclusion criteria included a history of gastrointestinal tract disorder, renal and hepatic impairment, known drug hypersensitivity, and upper respiratory tract infection or obstruction, which made breathing through nose difficult. [...]of short time of action for midazolam, the proportion of children with drowsiness decreased (77.7%) during the last phase. [...]comprehensive assessment of each phase of treatment may be compromised or even impossible because of clinical demands of the sedation. [...]video recording the whole appointment may have resulted in a more detailed behavior evaluation in this study.