A review of important elements in sedation study methodology.

The table demonstrates that there are few studies of behavioral indices mediated by a sedative(s) involving such sound scientific principles as blinding, reliability and validity, and control groups. Indeed, as is reflected in this report, it is not common to have measured physiological parameters along with the behavioral indices. Nonetheless, the reader should be aware that these clinical studies are difficult to conduct under the best of conditions. Extensive planning, piloting, instruments, and time are necessary to render even simple conclusions in today's studies. The need to standardize sedation protocols within and across studies is great if the profession ever hopes to develop a strong scientific basis for sedation. Only then can studies of drugs, their dosages, and their effects on children during dental procedures be compared and contrasted with any confidence. Behavioral scales need to be assessed and compared repeatedly and independently within and among studies so that an appreciation of the influence of a drug on one scale will have some meaningful translation to another scale. For instance, how does the Frankl scale compare to the Houpt scale, if at all? Should both or some facsimile of each be included in every study? What type of information is derived from the use of a given scale and does that information impact on other factors (e.g., physiological parameters or number of quadrants completed)? Should there be a priority for the use of one scale or another depending on the purpose of the study? Blinding and the establishment of reliability of behavioral measures should become as second-natured as giving local anesthesia.