Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults

Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.