The PediSedate® device, a novel approach to pediatric sedation that provides distraction and inhaled nitrous oxide: clinical evaluation in a large case series

• Published in: Pediatric anesthesia Vol. 17; no. 2; pp. 162 - 166
• Main Authors: DENMAN, WILLIAM T., TUASON, PACIFICO M., AHMED, MOHAMMED I., BRENNEN, LORALIE M., SOLEDAD CEPEDA, M., CARR, DANIEL B.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.02.2007
• Subjects: Age Factors; analgesia; Anesthesia, General - instrumentation; Anesthesia, General - psychology; Anesthetics, Inhalation - administration & dosage; Awareness - drug effects; Blood Pressure - drug effects; Child; Child, Preschool; children; distraction; Equipment and Supplies; Equipment Design - methods; Female; Heart Rate - drug effects; Humans; Male; nitrous oxide; Nitrous Oxide - administration & dosage; Oxygen - blood; Patient Satisfaction - statistics & numerical data; Postoperative Nausea and Vomiting - epidemiology; sedation; sedation devices; Treatment Outcome; Video Games - adverse effects; Video Games - psychology
• ISSN: 1155-5645; 1460-9592
• DOI: 10.1111/j.1460-9592.2006.02091.x

Summary Background:  Pediatric sedation is of paramount importance but can be challenging. Fear and anticipatory anxiety before invasive procedures often lead to uncooperativeness. A novel device (PediSedate®) provides sedation through a combination of inhaled nitrous oxide and distraction (video game). We evaluated the acceptability and safety of the PediSedate® device in children. Methods:  We enrolled children between 3 and 9 years old who were scheduled to undergo surgical procedures that required general inhalational anesthesia. After the device was applied, he/she played a video game while listening to the audio portion of the game through the earphones. Nitrous oxide in oxygen was administered via the nasal piece of the headset starting at 50% and increasing to 70%, in 10% increments every 8 min. Treatment failures, vital signs, arterial oxygen saturation, depth of sedation, airway patency, side effects, acceptance of the device and parental satisfaction were all evaluated. Results:  Of 100 children included, treatment failure occurred in 18% mainly because of poor tolerance of the device. At least 96% of the children who completed the study exhibited an excellent degree of sedation, 22% had side effects, and none experienced serious airway obstruction. Nausea and vomiting were the most common side effects and no patients had hemodynamic instability. Conclusions:  The PediSedate® device combines nonpharmacologic with pharmacologic methods of sedation. Most of the children we evaluated were able to tolerate the PediSedate® device and achieved an adequate degree of sedation.