Clinical and psychological effects of intravenous diazepam related to plasma levels. A controlled, double-blind, cross-over study in oral surgery involving local analgesia.

In a controlled, double-blind, cross-over study with diazepam (DZ) and placebo (PL) various clinical, psychological, and pharmacological parameters were studied in 33 patients having identical impacted third molars removed. The patients were admitted to the study consecutively and nonparametric statistics were used throughout the study for the evaluation (Wilcoxon's matched-pairs signed test). The following aspects were examined: Continous reaction times (CRT), rating scales (a.m. Beecher), blood pressure, pulse, plasma concentration of DZ and of N-desmethyldiazepam, visual changes, amnesia, adverse reactions, recalling of duration of surgery, orientation in time, phlebitis, and final evaluation performed by the patient. The operative conditions were found to be excellent, and only a few adverse effects were noticed. The patients expressed an overall enthusiasm about the sedation. In the rating scales only the predominantly sedative items were affected and not the anxiolytic ones. Neither the heart rate nor the systolic blood pressure were significantly changed; on the contrary, the DZ-group was less affected than the PL-group when maximum increases in the systolic blood pressure were compared in the two groups. The continuous reaction times were significantly correlated to the plasma concentrations of diazepam, especially 1 hour after sedation. The reported recurrence of initial clinical symptoms 6 hours after sedation due to the N-desmethyldiazepam could not be demonstrated in this study. The CRT has proved itself to be of great value in discriminating between different kinds of cerebral affections; the patients with DZ-intoxication showed significantly faster CRT 1 hour after injection than did patients suffering from well-documented cerebral disorders such as organic brain damage or hepatic encephalopathia.

RCT Entities:   Population Interventions Outcomes