Controlled comparison of a new sublingual lormetazepam formulation and i.v. diazepam in outpatient minor oral surgery
O'Boyle CA., Barry H., Fox E., McCreary C., Bewley A.
In a randomized, double-blind, parallel groups study, 40 patients undergoing surgical removal of impacted 3rd molar teeth received either sublingual lormetazapam 2.5 mg (n = 20) in a new cellulose wafer formulation followed at 35 min by i.v. saline; or sublingual placebo followed at 35 min by i.v. diazepam 10 mg (Diazemuls). Rapid onset of sedation was seen after sublingual lormetazepam, while the course and duration of postoperative sedation, measured using standard psychometric tests, was similar following both treatments. Surgeons's ratings indicated that sublingual lormetazepam was comparable to i.v. diazepam but patients' ratings indicated greater satisfaction with and preference for i.v. diazepam. Significant anterograde amnesia was found following both treatments. Both treatments were tolerated well, with no significant cardiovascular complications. These results indicate that sublingual lormetazapam may have a role in anaesthesia as a premedicant and for conscious sedation.