An investigation of the safety of midazolam use in hospital.

Abstract

To investigate whether an association exists between midazolam use and serious cardiorespiratory events or death. Retrospective analysis of data in an inpatient record linkage database, collected between March 1986 and October 1987 from 14 hospitals in the United States. A cohort of 19,112 patients who received injectable midazolam or diazepam on the same day that a medical procedure was performed. 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. 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. 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.