Summit Services and Albert Einstein Medical Center 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.
| Denman, William T; Tuason, Pacifico M; Ahmed, Mohammed I et al. (2007) The PediSedate device, a novel approach to pediatric sedation that provides distraction and inhaled nitrous oxide: clinical evaluation in a large case series. Paediatr Anaesth 17:162-6 |
