Purpose: The purpose was to describe characteristics and outcomes of restrained and nonrestrained patients enrolled in a randomized trial of protocolized sedation compared with protocolized sedation plus daily sedation interruption and to identify patient and treatment factors associated with physical restraint.
Methods: This was a post hoc secondary analysis using Cox proportional hazards modeling adjusted for center- and time-varying covariates to evaluate predictors of restraint use.
Results: A total of 328 (76%) of 430 patients were restrained for a median of 4 days. Restrained patients received higher daily doses of benzodiazepines (105 vs 41 mg midazolam equivalent, P < .0001) and opioids (1524 vs 919 μg fentanyl equivalents, P < .0001), more days of infusions (benzodiazepines 6 vs 4, P < .0001; opioids 7 vs 5, P = .02), and more daily benzodiazepine boluses (0.2 vs 0.1, P < .0001). More restrained patients received haloperidol (23% vs 12%, P = .02) and atypical antipsychotics (17% vs 4%, P = .003). More restrained patients experienced unintentional device removal (26% vs 3%, P < .001) and required reintubation (8% vs 1%, P = .01). In the multivariable analysis, alcohol use was associated with decreased risk of restraint (hazard ratio, 0.22; 95% confidence interval, 0.08-0.58).
Conclusions: Physical restraint was common in mechanically ventilated adults managed with a sedation protocol. Restrained patients received more opioids and benzodiazepines. Except for alcohol use, patient characteristics and treatment factors did not predict restraint use.
Trial registration: ClinicalTrials.gov NCT00675363.
Keywords: Chemical restraint; Daily sedation interruption; Intensive care; Physical restraint; Sedation protocol.
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