Abstract
The purpose of this study was to compare the clinical effects and adverse effects of doses of 0.2 mg/kg and 0.3 mg/kg midazolam, administration intranasally, and to determine the most appropriate concentration for the drug.
Forty-three mentally handicapped patients, aged 5 to 20 years, all of whom had previously exhibited highly combative and resistant behavior toward dental treatment under nitrous oxide/oxygen inhalation sedation, received either 0.2 mg /kg or 0.3 mg/kg of intranasal midazolam. The patients then received dental treatment combining nitrous oxide/oxygen inhalation (20-40% N2O/80-60% O2).
The initial sedative effects appeared within 5-10 minutes after the intranasal midazolam administration. No patient rejected the nasal mask or refused to inhale the nitrous oxide/oxygen. The success rate was evaluated as both “markedly effective” and “effective” for each dental procedure (oral-examination, injection, rubber-dam, cavity-preparation and restoration). The success rate for each dental procedure was 66.7-89.5% with 0.2 mg/kg, and with 0.3 mg/kg showed 83.3-95.2%. With both doses, the injection of local anesthesia showed the lowest success rates among all of the items. There were no significant differences between each rate in all of the dental procedures in both groups. In both groups, the majority of patients was discharged within 150 minutes of the intranasal instillation of midazolam. At no time during the course of this study were any adverse effects observed in the 0.2 mg/kg dose group. However, the 0.3 mg/kg dose group exhibited respiratory depression (below 94% in SpO2 or sometimes needing jaw-lift) in 4 cases and vomiting in one case.
The rates of the overall clinical usefulness after evaluation of the clinical sedative effects and adverse effects, were 77.3% for 0.2 mg/kg and 76.2% for 0.3 mg/kg. Therefore, no clinical benefit was observed using the higher dose of 0.3 mg/kg midazolam. We recommend using the lower dose of 0.2 mg/kg intranasal midazolam.
