Aims Assess the effects of protocol-directed sedation management on the duration of mechanical ventilation and other relevant patient outcomes in mechanically ventilated intensive care unit patients.

Background Sedation is a core component of critical care. Sub-optimal sedation management incorporates both under- and over-sedation and has been linked to poorer patient outcomes.

Design Cochrane systematic review of randomized controlled trials.

Data sources Cochrane Central Register of Controlled trials, MEDLINE, EMBASE, CINAHL, Database of Abstracts of Reviews of Effects, LILACS, Current Controlled Trials and US National Institutes of Health Clinical Research Studies (1990–November 2013) and reference lists of articles were used.

Review methods Randomized controlled trials conducted in intensive care units comparing management with and without protocol-directed sedation were included. Two authors screened titles, abstracts and full-text reports. Potential risk of bias was assessed. Clinical, methodological and statistical heterogeneity were examined and the random-effects model used for meta-analysis where appropriate. Mean difference for duration of mechanical ventilation and risk ratio for mortality, with 95% confidence intervals, were calculated.

Results Two eligible studies with 633 participants comparing protocol-directed sedation delivered by nurses vs. usual care were identified. There was no evidence of differences in duration of mechanical ventilation or hospital mortality. There was statistically significant heterogeneity between studies for duration of mechanical ventilation.

Conclusions There is insufficient evidence to evaluate the effectiveness of protocol-directed sedation as results from the two randomized controlled trials were conflicting.