Relieving Pediatric Immunization Pain Using A Reusable Personal Device

描述（由申请人提供）：针刺是儿童经历的最常见和最痛苦的医疗程序。由此产生的针头恐惧症降低了父母对免疫接种的依从性，并影响了患者随后与卫生保健系统的互动，导致诊断延迟，拒绝献血，甚至死亡。目前的产品依赖于医疗保健专业人员自愿使用混乱，无效和耗时的干预措施来治疗许多人认为微不足道的疼痛。一种直接提供给消费者的立即有效的可重复使用的疼痛缓解装置可以减少世界范围内的发病率和痛苦。快速静脉穿刺疼痛缓解的市场很大;立即免疫缓解的市场更大且尚未开发。将一个小型非侵入性装置放置在距离针头部位近端几厘米处，可显著降低成人静脉穿刺疼痛，而不会影响静脉注射开始的成功率。该项目的第一阶段评估了60名接受入学免疫接种的4 - 6岁儿童使用该设备与标准护理的疼痛和焦虑缓解，易用性和产品接受度。同时，原型将加强，以促进儿科疼痛缓解分散可爱的设计。该项目的第二阶段是一项三组安慰剂对照试验，旨在证明接受计划接种疫苗的四个年龄组的疼痛减轻：4-6个月（n=120），12-15个月（n=60），4-6岁（n=60）和11-12岁（n=75）。采用各种年龄适当的措施，由设盲研究人员通过录像带编码评估疼痛缓解情况，适当时由父母、护士和儿童自我报告。患者将被随机分配到三组中的一组：安慰剂组、标准治疗组和使用器械组。进一步的专业设计将包括微电子增强、内部冷却组件、抓取和捆绑皮肤以进行自注入的选项、耐久性测试和功率效率改进。大量的文献暗示了儿科针痛的影响和缺乏良好的解决方案。所提出的装置克服了现有产品的缺点，并且消费者容易带去看医生并自己使用。这些项目将改善和展示急需的干预措施对每个儿童造成的疼痛的有效性。

DESCRIPTION (provided by applicant): Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents' compliance with immunizations and affects patients' subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant. An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large; the market for immediate immunization relief is larger and untapped. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product acceptance using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, placebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be assessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child.