Premedication with midazolam is equally effective via the sublingual and intravenous route of administration

Background. The aim of this study was to investigate the clinical efficacy and potential side effects of sublingual midazolam, used for premedication, in comparison with intravenous midazolam. The second aim was to explore cost-effectiveness of sublingual midazolam administration. Methods. A prospective, randomized, controlled, single-blinded trial was conducted at the Clinical Hospital Centre Osijek, Croatia, during the period 1st of May till 31st of October, 2012. We enrolled 140 patients (American Society of Anesthesiologists (ASA) physical status I-II, age≥18 years) scheduled for some kind of elective surgical procedure. Exclusion criteria were ASA III or higher, psychiatric disorders, allergy to midazolam and use of psychotropic drugs. Patients were randomized into one of two groups. One group received 2.5 mg of midazolam intravenously and the other group received 1/4 of a midazolam tablet (approximately 3.75 mg) sublingually. Sedation was clinically evaluated using the Ramsey sedation scale at 0, 10, 20 and 30 minutes after drug administration. We also noted side effects and degree of amnesia. Results. Ten minutes after administration of premedication, a significantly higher number of patients in the intravenous group had a Ramsey score of 2 (p=0.000). Ten and twenty minutes after drug administration, most of the patients in the sublingual group had a Ramsey score 1-2, and after 30 minutes most of them had a Ramsey score 2-3, which is comparable with the intravenous (p=0.642) group. Conclusion. Sublingual application of midazolam has an equivalent sedative effect as intravenous midazolam 20 minutes after administration but is associated with a bitter taste and weaker amnestic effect