Safety and efficacy of flumazenil in reversing conscious sedation in the emergency department

Objectives: To evaluate the safety and efficacy of flumazenil vs placebo in reversing fentanyl and midazolam-induced conscious sedation in ED patients undergoing a short, painful procedure. Methods: This was a multicenter, randomized, parallel, double-blind, placebo-controlled study conducted at 9 university-affiliated teaching hospitals. Patients >18 years of age requiring conscious sedation for a painful procedure expected to last <20 minutes were eligible for inclusion in the study. Patients received 2 mu g/kg of fentanyl, followed by midazolam titrated to the desired level of sedation, Patients were then randomized to receive either flumazenil or placebo in a 3:1 ratio (flumazenil:placebo). Vital signs, O-2 saturation, and alertness were recorded at regular intervals. Prior to ED release, patients were asked to rate the amount of discomfort they experienced and the level of relaxation achieved on a 10-cm visual analog scale (VAS, They also were questioned about their recall for the procedure and satisfaction with the drug regimen. Physicians also rated their satisfaction with the drug regimen on a IO-cm VAS. Results: Overall, 133 patients received flumazenil and 46 patients received placebo. Patients in the 2 groups received similar doses of midazolam. The patients who received flumazenil returned to baseline alertness earlier (11.1 min vs 24.8 min, p < 0.001) and at a faster rate than did the patients given placebo. Actual intervals from procedure completion until release from the ED did not differ between the 2 groups (98.2 +/- 3.6 min flumazenil vs 96.9 +/- 5.8 min placebo; p = 0.89). The amounts of discomfort experienced, levels of relaxation achieved, recalls for the procedure, and both patient and physician satisfactions were also similar for the 2 groups. There were no serious adverse effects related to the study drug, and minor adverse effects were similar for the 2 groups. Conclusion: Flumazenil is safe and efficacious in reversing midazolam-induced sedation in ED patients given a combination of fentanyl and midazolam to facilitate the performance of a short, painful procedure, The patients given flumazenil returned to baseline alertness earlier and at a faster rate than did the patients given placebo. However, flumazenil did not alter the actual interval from procedure completion until ED release.