Flumazenil in the management of acute drug overdosage with benzodiazepines and other agents.

A double-blind, randomized, placebo-controlled trial was employed to evaluate the place of flumazenil, a benzodiazepine antagonist, in the early management of 60 patients who went to an accident and emergency center with overdosage of sedatives. The level of consciousness was monitored by a modified Glasgow Coma Scale, and the response to the intravenous administration of up to 1 mg flumazenil or placebo was followed for periods between 1 and 24 hours. The increases in the glasgow coma scale at 5 minutes in the flumazenil-treated group were significant in the group as a whole (+4.9; P less than 0.005), in those who had taken benzodiazepines only (+5.3; P = 0.005), and in those with mixed overdosages (+5.6; P less than 0.005). There were no significant changes in the placebo-treated group. Some patients with overdosage with ethanol also responded to flumazenil, but there was no effect in patients with overdosage of barbiturates alone or tricyclic antidepressants. Flumazenil was well tolerated although three patients had mild withdrawal reactions. The need for intensive physiologic support was avoided in several cases, and the differential diagnosis of the unconscious patient was facilitated.

RCT Entities:   Population Interventions Outcomes