Hersh Elliot V, Pinto Andres, Saraghi Mana, Saleh Najeed, Pulaski Lisbeth, Gordon Sharon M, Barnes Douglas, Kaplowitz Gary, Bloom Ira, Sabti Mohammad, Moore Paul A, Lee Sean, Meharry Michael, He David Y, Li Yiming
J Am Dent Assoc. 2016 Apr;147(4):278-87. doi: 10.1016/j.adaj.2015.12.008. Epub 2016 Jan 25.
The authors compared the local anesthetic efficacy and safety of an intranasally administered formulation of tetracaine and oxymetazoline (K305) with placebo in adult participants undergoing single dental restorative procedures in teeth nos. 4 through 13.
The authors screened and allocated 150 participants in a double-masked, randomized fashion to either K305 or placebo nasal spray. The authors delivered the study drug as two 0.2-milliliter sprays separated by 4 minutes inside the nostril on the side ipsilateral to the tooth being treated. The authors administered a third 0.2-mL spray, if necessary, and administered 4% articaine with 1:200,000 epinephrine by means of injection if anesthesia was inadequate. Safety evaluations included participant reports of adverse events, vital signs, and alcohol sniff tests during the 2-hour study period and at a 1-day follow-up visit. The primary efficacy end point was anesthetic success defined as the completion of the dental procedure without the need for rescue injectable local anesthetic. The authors evaluated differences in success rates observed between K305 and placebo by using a 1-sided Fisher exact test.
The overall success rates were 88.0% (95% confidence interval, 80.0-93.6) and 28% (95% confidence interval, 16.2-42.5) for K305 and placebo, respectively (P < .0001). The most frequent adverse effects in the K305 group were rhinorrhea (57.0%) and nasal congestion (26.0%). No serious adverse events occurred during this study.
K305 was effective and well tolerated during restorative procedures in adult participants.
K305 provides a needleless alternative for obtaining maxillary pulpal anesthesia on premolars, canines, and incisors.
作者比较了丁卡因和羟甲唑啉鼻内给药制剂（K305）与安慰剂对接受4至13号牙齿单颗牙齿修复手术的成年参与者的局部麻醉效果和安全性。
作者以双盲、随机方式筛选并分配150名参与者，分别给予K305或安慰剂鼻喷雾剂。作者在患牙同侧鼻孔内分两次给予研究药物，每次0.2毫升喷雾剂，间隔4分钟。如有必要，给予第三次0.2毫升喷雾剂；若麻醉不足，则通过注射给予含1:200,000肾上腺素的4%阿替卡因。安全性评估包括参与者在2小时研究期间及1天随访时报告的不良事件、生命体征和酒精嗅觉测试。主要疗效终点为麻醉成功，定义为无需抢救性注射局部麻醉剂即可完成牙科手术。作者使用单侧Fisher精确检验评估K305和安慰剂之间观察到的成功率差异。
K305和安慰剂的总体成功率分别为88.0%（95%置信区间，80.0 - 93.6）和28%（95%置信区间，16.2 - 42.5）（P <.0001）。K305组最常见的不良反应为鼻溢（57.0%）和鼻充血（26.0%）。本研究期间未发生严重不良事件。
K305在成年参与者的修复手术中有效且耐受性良好。
K305为获得上颌前磨牙、尖牙和切牙牙髓麻醉提供了一种无针替代方法。
