We will develop and manufacture a prototype of the "Pediatric Sedation Device" in Phase I. This device will be utilized for conscious sedation in pediatric patients undergoing painful procedures or diagnostic evaluations. In Phase II, clinical trials will be conducted. Nitrous Oxide and Oxygen will be dispensed in variable amounts, not to exceed 50% nitrous oxide and 50% oxygen. A dispensed in variable amounts, not to exceed 50% nitrous oxide and 5% oxygen. A wireless two-way communication system, a wireless audio VCR component, "Brown-scavenger system and pulse oximetry are features 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 clinical trials, effectiveness of the device will be determined by pre and post procedure measures of: parental anxiety, the child's subjective experience of distress (pain and anxiety), physiologic arousal and cooperativeness. The cost savings to the health care system will be measured primarily by comparison of the amount of time to manage similar patients using the device relative to standard techniques.Awardee's statement of the potential commercial applications of the research:The pediatric sedation device will enable Emergency Medicine, Oncology, Dental, Orthopedic, Pediatric, Radiologic, and Anesthesia physicians to treat pediatric patients with minor traumatic injuries or those undergoing difficult procedures in a safe, humane, and cost effective manner.National Institute of Child Health and Human Development (NICHD)
