Flumazenil in drug overdose: Randomized, placebo-controlled study to assess cost effectiveness

Objective: To investigate cost effectiveness of administration of flumazeni l to patients presenting with suspected acute drug overdose. Design: Doubie-blind, prospective, placebo-controlled randomized study. Setting: University teaching hospital. Patients: Forty-three adults presenting with suspected drug overdose and ha ving a Glasgow Coma Scale (GCS) score of <13. Patients with known benzodiaz epine/tricyclic ingestion were excluded. Interventions: Intravenous administration of flumazenil (up to 2 mg) or pla cebo. Measurements and Main Results: Individual patient costs were assessed and d ata aggregated for each treatment group. Major diagnostic and therapeutic i nterventions were recorded and between group comparisons performed. Clinica l response to study drug administration was assessed by obtaining pre- and post drug GCS scores and observation of the patient for at least 180 mins f or signs of resedation. Aggregate cost or number of major diagnostic and therapeutic interventions were not different between groups. Patients randomized to the flumazenil gr oup showed a marked increase in GCS score (7.4 to 11.8) compared with those in the placebo group (8.2 to 8.6). Conclusion: Use of flumazenil in intentional drug overdose unknown etiology is not cast effective.