AN INVESTIGATION OF THE SAFETY OF MIDAZOLAM USE IN-HOSPITAL

Objective - To investigate whether an association exists between midaz olam use and serious cardiorespiratory events or death. Design - Retro spective analysis of data in an inpatient record linkage database, col lected between March 1986 and October 1987 from 14 hospitals in the Un ited States. Patients - A cohort of 19,112 patients who received injec table midazolam or diazepam on the same day that a medical procedure w as performed. Main outcome measures - An attempt was made to identify suspected serious cardiorespiratory adverse events and deaths that occ urred within 24 h of study-drug administration. Death rates within 24 h following study-drug administration were compared between patients w ho received injectable midazolam and those who received injectable dia zepam. Results - Validation analysis of the information in the compute rized record linkage database indicated that serious cardiac and respi ratory adverse events that occurred within 24 h of study-drug administ ration could not be reliably identified. Therefore, a comparison of th e serious cardiorespiratory adverse event rates following administrati on of midazolam versus diazepam could not be made. Death rates within 24 h of study-drug administration could be evaluated. For the cohort a s a whole, the death rate was significantly lower among patients who r eceived midazolam than among those who received diazepam (0.76% versus 1.93%, p<0.01). This difference remained statistically significant, a fter adjusting for age, sex, comorbidity diagnosis, concomitant drug u se, type of medical procedure, and hospital size and teaching capabili ty. Conclusions - The results suggest that there is no increased risk of death associated with midazolam administration when compared to dia zepam administration for endoscopic, conscious sedative, and general a nesthetic procedures in hospitals. (C) 1997 by John Wiley & Sons, Ltd.