An investigation of the safety of midazolam use in hospital

Abstract

Objective: To investigate whether an association exists between midazolam use and serious cardiorespiratory events or death.

Design: Retrospective analysis of data in an inpatient record linkage database, collected between March 1986 and October 1987 from 14 hospitals in the United States.

Patients: A cohort of 19,112 patients who received injectable midazolam or diazepam on the same day that a medical procedure was performed.

Main outcome measures: An attempt was made to identify suspected serious cardiorespiratory adverse events and deaths that occurred within 24 h of study-drug administration. Death rates within 24 h following study-drug administration were compared between patients who received injectable midazolam and those who received injectable diazepam.

Results: Validation analysis of the information in the computerized record linkage database indicated that serious cardiac and respiratory adverse events that occurred within 24 h of study-drug administration could not be reliably identified. Therefore, a comparison of the serious cardiorespiratory adverse event rates following administration of midazolam versus diazepam could not be made. Death rates within 24 h of study-drug administration could be evaluated. For the cohort as a whole, the death rate was significantly lower among patients who received midazolam than among those who received diazepam (0.76% versus 1.93%, p<0.01). This difference remained statistically significant, after adjusting for age, sex, comorbidity diagnosis, concomitant drug use, type of medical procedure, and hospital size and teaching capability.

Conclusions: The results suggest that there is no increased risk of death associated with midazolam administration when compared to diazepam administration for endoscopic, conscious sedative, and general anesthetic procedures in hospitals.