Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, No. 56 South Lishi Road, Xicheng District, Beijing, 100045, China.
Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.
Off-label intranasal administration of injectable dexmedetomidine has been widely applied in the pediatric sedation setting. However, the development of an improved drug delivery system that is easy to use is needed. We developed a novel dexmedetomidine nasal spray that can be administered directly without dilution or configuration for pediatric pre-anesthetic sedation. This nasal spray has a fixed dose and is stable during storage. To the best of our knowledge, this is the first licensed nasal spray preparation of dexmedetomidine worldwide.
To evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children.
The study was conducted at 11 sites in China between 24 November 2021 and 20 May 2022 and was registered in ClinicalTrials.gov (NCT05111431, first registration date: 20/10/2021). Subjects (n = 159) between 2 and 6 years old who were to undergo elective surgery were randomized to the dexmedetomidine group (n = 107) or the placebo group (n = 52) in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the stratified body weight. The primary outcome measure was the proportion of subjects who achieved the desired child-parent separation and Ramsay scale ≥ 3 within 45 min of administration. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation.
The proportion of subjects achieving desired parental separation and Ramsay scale ≥ 3 within 45 min was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) (P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach desired parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity.
This novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.
注射用右美托咪定经鼻给药在儿科镇静治疗中已得到广泛应用。然而，需要开发一种易于使用的改良药物输送系统。我们开发了一种新的右美托咪定鼻喷雾剂，可直接使用，无需稀释或配置，用于小儿术前镇静。这种鼻喷雾剂具有固定剂量，在储存过程中稳定。据我们所知，这是全球首个获得许可的右美托咪定鼻喷雾剂。
评估新型右美托咪定鼻喷雾剂在儿童中的术前镇静效果和安全性。
该研究于 2021 年 11 月 24 日至 2022 年 5 月 20 日在中国的 11 个地点进行，在 ClinicalTrials.gov 注册（NCT05111431，首次注册日期：2021 年 10 月 20 日）。纳入 2-6 岁择期手术的患儿，按 2:1 的比例随机分为右美托咪定组（n=107）或安慰剂组（n=52）。根据分层体重，剂量为 30μg 或 50μg。主要结局指标为给药 45 分钟内达到期望的患儿-家长分离和 Ramsay 评分≥3 的患儿比例。通过不良事件、血压、心率、呼吸频率和血氧饱和度的评估监测安全性。
右美托咪定组（94.4%）达到期望的父母分离和 Ramsay 评分≥3 的患儿比例明显高于安慰剂组（32.0%）（P<0.0001）。与安慰剂相比，右美托咪定治疗使更多的患儿达到 Ramsay 评分≥3 或 UMSS≥2，且达到期望的父母分离、Ramsay 评分≥3 和 UMSS≥2 的时间更短（均 P<0.0001）。右美托咪定组和安慰剂组分别有 90.7%和 84.0%的患儿报告不良事件，所有事件均为轻度或中度。
这种新型右美托咪定鼻喷雾剂在儿童中表现出有效的术前镇静作用，具有可耐受的安全性。
