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

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Abstract

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.

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