PURPOSE: The purpose of this study was to compare the safety and effectiveness of oral and intranasal midazolam in healthy children by evaluating their physiological and behavioral responses. METHODS: Regimen A patients received 0.5 mg/kg oral midazolam with an intranasal saline spray placebo at their first appointment and 03 mg/kg intranasal midazolam with an oral midazolam placebo at their second appointment. Regimen B patients received the medications in the reverse order at each appointment. Physiological parameters and behavior ratings were recorded. RESULTS: There were no significant differences in physiologic parameters in the 2 treatment groups, except for significantly lower oxygen saturation in the oral group at t=20 minutes (P=.03) The oral group showed significantly lower crying scores at t=5 minutes (P=.02), and lower overall behavior scores at t=papoose and t=5 minutes (P=.04 and .03, respectively). Oral sedations were given ratings by providers of "effective" and "very effective" significantly more than intranasal sedations (P<.05). CONCLUSIONS: Both regimens have similar behavioral outcomes, with the oral group having improved crying and overall behavior early in the appointment, Oral sedations were considered to be more effective by providers than intranasal sedations. Clinically significant desaturations occur in both regimens, indicating the need for operators to recognize and respond to the need for airway correction according to American Academy of Pediatric Dentistry guidelines.
RCT Entities:
PURPOSE: The purpose of this study was to compare the safety and effectiveness of oral and intranasal midazolam in healthy children by evaluating their physiological and behavioral responses. METHODS: Regimen A patients received 0.5 mg/kg oral midazolam with an intranasal saline spray placebo at their first appointment and 03 mg/kg intranasal midazolam with an oral midazolam placebo at their second appointment. Regimen B patients received the medications in the reverse order at each appointment. Physiological parameters and behavior ratings were recorded. RESULTS: There were no significant differences in physiologic parameters in the 2 treatment groups, except for significantly lower oxygen saturation in the oral group at t=20 minutes (P=.03) The oral group showed significantly lower crying scores at t=5 minutes (P=.02), and lower overall behavior scores at t=papoose and t=5 minutes (P=.04 and .03, respectively). Oral sedations were given ratings by providers of "effective" and "very effective" significantly more than intranasal sedations (P<.05). CONCLUSIONS: Both regimens have similar behavioral outcomes, with the oral group having improved crying and overall behavior early in the appointment, Oral sedations were considered to be more effective by providers than intranasal sedations. Clinically significant desaturations occur in both regimens, indicating the need for operators to recognize and respond to the need for airway correction according to American Academy of Pediatric Dentistry guidelines.