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

OBJECTIVE: To investigate cost effectiveness of administration of flumazenil to patients presenting with suspected acute drug overdose.

DESIGN: Double-blind, prospective, placebo-controlled randomized study.

SETTING: University teaching hospital.

PATIENTS: Forty-three adults presenting with suspected drug overdose and having a Glasgow Coma Scale (GCS) score of <13. Patients with known benzodiazepine/tricyclic ingestion were excluded.

INTERVENTIONS: Intravenous administration of flumazenil (up to 2 mg) or placebo.

MEASUREMENTS AND MAIN RESULTS: Individual patient costs were assessed and data aggregated for each treatment group. Major diagnostic and therapeutic interventions were recorded and between group comparisons performed. Clinical 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 for signs of resedation. Aggregate cost or number of major diagnostic and therapeutic interventions were not different between groups. Patients randomized to the flumazenil group 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 of unknown etiology is not cost effective.