A prospective randomised pilot study of sedation regimens in a general ICU population: a reality-based medicine study

Forty patients were randomised to intermittent diazepam or continuous midazolam and sedation monitored with hourly sedation scores; 31 patients completed the study. Scores indicating undersedation were more common with diazepam (P <0.01); overall adequate sedation midazolam 64.7%, diazepam 35.7% (P =0.21). No patient exhibited inappropriately prolonged sedation. Cost was: midazolam AUS$1.98/h; diazepam AUS$0.06/h.Both regimens produced rapid onset of acceptable sedation but undersedation appeared more common with the cheaper diazepam regimen. At least 140 patients should be studied to provide evidence applicable to the general ICU population. Used alone, a sedation score may be an inappropriate outcome measure for a sedation trial.To provide the highest quality patient care, an intensive care unit (ICU) must constantly review treatment in search of 'best practice' for that unit. The medical literature is the prime source of evidence and randomised controlled trials (RCTs) are considered the gold standard for the evaluation of competing treatments. Nevertheless, RCTs have been criticised as strict inclusion and exclusion criteria may exclude the very patients who clinicians are obliged to treat [1]. The conduct of trials in intensive care is further complicated by the varying case-mix between different units so that the results of even perfectly conducted studies may not be relevant to a unit with a different case-mix. As a result, it becomes necessary to develop protocols and systems for examining practice in one's own unit.ICU sedation regimens provide a good example of the difficulty of extrapolating evidence from the literature to one's own practice. For logistical reasons most sedation studies in intensive care are carried out on patients undergoing short-term sedation following elective surgical procedures. This patient population is not representative of the population of our general ICU, making such results inapplicable to our patients.Two sedative regimens h