Intranasal Fentanyl Combined with Oral Midazolam for Pediatric Dental Sedation: A Controlled Randomized Blinded Crossover Clinical Trial.

Purpose: The purpose of this study was to compare the effectiveness of intranasal fentanyl combined with oral midazolam to oral midazolam alone in pediatric dental patients. Methods: Thirty-two uncooperative healthy children aged three to six years old, who met the inclusion criteria, were randomly assigned to receive oral midazolam (0.7 mg/kg) with either intranasal fentanyl (one μg/kg) or intranasal placebo (saline). A controlled, randomized, double-blinded, crossover clinical trial design was followed so that each child received both regimens. Data collected included the onset of sedation, working time, sedation and behavior assessment, and occurrence of side effects. Results: The onset of sedation time was not statistically different between the two groups (P=0.62), while the median working time of the midazolam/fentanyl sedation was sig- nificantly longer than the midazolam sedation (P<0.001). Sedation scores were significantly better with the midazolam/fentanyl sedation regimen at separation from parents (P=0.032), local anesthesia administration (P=0.018), rubber dam application (P=0.035), after five minutes of dental treatment (P=0.035), after 10 minutes (P=0.039), after 15 minutes (P=0.012), and after 20 minutes (P=0.038). Behavior scores were significantly better with the midazolam/fentanyl sedation only at local anesthesia administration (P=0.021), rubber dam placement (P=0.004), and after five minutes of dental treatment (P=0.049). Minor side effects occurred in 12.5 percent of sedation procedures and were not significantly associated with either of the two groups (P=0.70). Conclusion: The combination of oral midazolam with intranasal fentanyl sedation, when compared to oral midazolamas a single agent, significantly improved sedation and behavior during local anesthesia and operative dentistry for healthy three- to six-year-old children in addition to prolonged sedation working time.