Fentanyl has been widely used as a premedication prior to numerous surgical procedures. But its potential as a premedication in pediatric dentistry is yet to be explored. The purpose of this randomized, triple blind, crossover study was to compare the safety and efficacy of a combination of oral midazolam combined with submucosally administered fentanyl (MF) and oral midazolam combined with submucosally administered placebo (MP), for the sedation of children undergoing dental treatment.