Efficacy of Extemporaneous Sublingual Midazolam Gel for Sedation

Midazolam is commonly used for conscious sedation in anxiety patients undergoing oral surgery procedures. Sublingual administration is a noninvasive technique and can achieve rapid absorption. Objective: To compare the efficacy of extemporaneous sublingual midazolam gel to oral midazolam for conscious sedation in patients undergoing surgical removal impacted teeth. Method: Study design was double-blinded randomized control trial. Extemporaneous midazolam gel was prepared by mixing injection form of midazolam (Dormicum 15mg/3ml) 0.25mg/ml (maximum dose=12.5mg) with 3% hydroxyethylcellulose and oral midazolam was prepared by mixing injection form of midazolam 0.5mg/kg (maximum dose=22.5mg) with flavored sterile water 20ml. Thirty-two patients were recruited and randomly assigned to undergo sedation by either sublingual or oral technique in the same procedure. Onset time, Recovery time, Sedative scores, Plasma concentration of midazolam were recorded. After drug administration, blood samples were taken at 0, 5, 10, 15, 30, 45, 60, 90 and 150 min to detect concentration of midazolam in plasma by using fluorescence polarization immunoassay (FPIA). Data were analyzed by Student's t-test for ratio scale and by Mann-Whitney U test for ordinal scale. Results: The results showed that the average of recovery time of oral group (217±44 min) was prolonged significantly (p<0.05) when compared to the sublingual group (166±29 min). It was consistent with the plasma concentration of midazolam at 150 min in sublingual group (77±27 ng/ml) which was significantly (p<0.05) less than oral group (113±14 ng/ml). The difference of onset time between groups (sublingual gel=15±3 min, oral=14±6 min) was not significant. The sedation level in sublingual group was not different from oral group. Conclusion: It can be concluded that low dose sublingual gel midazolam (0.25mg/kg) enhanced onset, sedation level and plasma concentration similar to oral midazolam (0.5mg/kg) but rapid recovery. This study was supported by graduate school and Faculty of Dentistry, Prince of Songkla University, Thailand.