Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

doi:10.1186/s12871-024-02708-1

科研成果详情

题名	Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial
作者	Gao, Jia 1; Wang, Fang 1; Wang, Xiaoling 2; Zou, Xiaohua 3; Liu, Hua-cheng4,5,6; Song, Xingrong 7; Chai, Xiaoqing 8; Jiang, Rong 9; Zhao, Ping 10; Zhang, Jiaqiang 11; Wang, Sai-ying 12; Ma, Haichun 13; Zhao, Zhibin 14; Wang, Quanren 15; Zhou, Na 15; Bai, Jianling 16; Zhang, Jianmin 1
发表日期	2024-09-06
发表期刊	BMC Anesthesiology 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Dexmedetomidine Intranasal Pediatric Sedation Pre-anesthetic
其他关键词	INTRANASAL DEXMEDETOMIDINE ; COMPUTED-TOMOGRAPHY ; MIDAZOLAM ; MEDICATION ; COMBINATION ; KETAMINE
摘要	Background: 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. Objective: To evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children. Methods: 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 mu g or 50 mu g 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. Results: 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. Conclusions: This novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.
资助项目	Jiangsu Hengrui Pharmaceuticals Co., Ltd
出版者	BMC
ISSN	1471-2253
卷号	24 期号:1
DOI	10.1186/s12871-024-02708-1
页数	9
WOS类目	Anesthesiology
WOS研究方向	Anesthesiology
WOS记录号	WOS:001308103500006
收录类别	SCIE ; SCOPUS ; PUBMED
URL	查看原文
PubMed ID	39242499
SCOPUSEID	2-s2.0-85203282488
通讯作者地址	[Zhang, Jianmin]Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Dept Anesthesiol, 56 South Lishi Rd, Beijing 100045, Peoples R China.
Scopus学科分类	Anesthesiology and Pain Medicine
SCOPUS_ID	SCOPUS_ID:85203282488
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/218553
专题	附属第二医院第二临床医学院、附属第二医院、育英儿童医院附属第二医院_麻醉科附属第二医院_麻醉重点学科实验室
通讯作者	Zhang, Jianmin
作者单位	1.Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Dept Anesthesiol, 56 South Lishi Rd, Beijing 100045, Peoples R China; 2.Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Dept Pharm, Beijing, Peoples R China; 3.Guizhou Med Univ, Affiliated Hosp, Dept Anesthesiol, Guiyang, Peoples R China; 4.Wenzhou Med Univ, Affiliated Hosp 2, Dept Anesthesiol & Perioperat Med, Wenzhou, Peoples R China; 5.Wenzhou Med Univ, Yuying Childrens Hosp, Wenzhou, Peoples R China; 6.Wenzhou Med Univ, Key Lab Anesthesiol Zhejiang Prov, Wenzhou, Peoples R China; 7.Guangzhou Med Univ, Guangzhou Women & Childrens Med Ctr, Dept Anesthesiol, Guangzhou, Peoples R China; 8.Anhui Prov Hosp, Dept Anesthesiol, Hefei, Peoples R China; 9.Sichuan Prov Peoples Hosp, Dept Anesthesiol, Chengdu, Peoples R China; 10.China Med Univ, Shengjing Hosp, Dept Anesthesiol, Shenyang, Peoples R China; 11.Henan Prov Peoples Hosp, Dept Anesthesiol & Perioperat Med, Zhengzhou, Peoples R China; 12.Cent South Univ, Xiangya Hosp 3, Dept Anesthesiol, Changsha, Peoples R China; 13.First Hosp Jilin Univ, Dept Anesthesiol, Changchun, Peoples R China; 14.First Peoples Hosp Lianyungang, Dept Anesthesiol, Lianyungang, Peoples R China; 15.Jiangsu Hengrui Pharmaceut Co Ltd, Shanghai, Peoples R China; 16.Nanjing Med Univ, Sch Publ Heath, Dept Biostat, Nanjing, Jiangsu, Peoples R China
推荐引用方式 GB/T 7714	Gao, Jia,Wang, Fang,Wang, Xiaoling,et al. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial[J]. BMC Anesthesiology,2024,24(1).
APA	Gao, Jia., Wang, Fang., Wang, Xiaoling., Zou, Xiaohua., Liu, Hua-cheng., ... & Zhang, Jianmin. (2024). Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiology, 24(1).
MLA	Gao, Jia,et al."Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial".BMC Anesthesiology 24.1(2024).