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.