Pediatric Conscious Sedation Device

We will develop and manufacture a prototype of the "Pediatric Sedation Device" in Phase I. Thisdevice will be utilized for conscious sedation in pediatric patients undergoing painful procedures ordiagnostic evaluations. In Phase II, clinical trials will be conducted. Nitrous Oxide and Oxygen will bedispensed in variable amounts, not to exceed 50% nitrous oxide and 50% oxygen. A dispensed invariable amounts, not to exceed 50% nitrous oxide and 5% oxygen. A wireless two-way communica-tion system, a wireless audio VCR component, "Brown-scavenger system and pulse oximetry arefeatures which are integral in providing the pediatric patient and health care system with a safe,psychologically positive, and a cost-effective conscious sedation modality. During Phase II's clinicaltrials, effectiveness of the device will be determined by pre and post procedure measures of: parentalanxiety, the child's subjective experience of distress (pain and anxiety), physiologic arousal andcooperativeness. The cost savings to the health care system will be measured primarily by comparisonof the amount of time to manage similar patients using the device relative to standard techniques.