A double-blind comparison of the efficacy of lorazepam FDDF versus placebo for anesthesia premedication in children.

Lorazepam was tried in a new formulation (FDDF) as premedication in twenty children, aged between 5-10 years. The study was performed in a double-blind fashion using lorazepam 1 mg and placebo in identical FDDF preparations. No significant differences were observed between the two treatment groups except for the recall of the venipuncture and awakening. Because of the lack of sedation observed the study was completed with an open trial on ten new subjects receiving 2 mg lorazepam FDDF. The quality of premedication was not found improved while more secretions were observed in the 2 mg lorazepam group. Recall of venipuncture and awakening was significantly less frequent in the 2 mg lorazepam group as compared to placebo. In both lorazepam groups awakening from anesthesia was prolonged. Side effects were reported in several patients receiving lorazepam. As lorazepam FDDF performed not better than a placebo as premedication for children its use is not recommended in pediatric anesthesia.