[Safety and efficacy of midazolam in children under mechanical ventilation in the intensive care unit]

The use of midazolam for children was approved in March, 2010. Since the efficacy and safety data of midazolam used in children, excluding low-birth-weight infants and newborns, for "sedation under artificial respiration in intensive care units" were quite limited, a post-marketing survey was carried out to confirm the validity of the established dosage and administration.A consecutive enrollment method was adopted. Based on the data of 153 patients collected from 8 institutes, efficacy and safety profiles were analyzed.Among the 149 patients included in the safety analysis set, 6 adverse reactions were reported in 6 patients. The incidence of adverse events was 4.0% (6/149). Reported adverse reactions included depressed level of consciousness: 1 event, delirium: 1 event, psychomotor hyperactivity: 1 event, hypotension: 2 events, and blood pressure increase: 1 event. Serious adverse drug reaction (ADR) reported in this survey was depressed level of consciousness. This ADR resolved on the following day after the treatment with flumazenil. Paradoxical reactions were reported in 1 patient, and tolerance was reported in 2 patients. The efficacy rate was 96.5% (138/143).No additional safety issues (status of adverse reactions, status of adverse events, status of serious adverse events, etc.) and efficacy issue were manifest in the patients treated with the dosage and administration method established at the approval of the drug.