Evidence map›Paper›PMID 39242499›Full record

Trial reportBMC anesthesiology2024

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

Jia Gao, Fang Wang, Xiaoling Wang, Xiaohua Zou, Hua-Cheng Liu, Xingrong Song, Xiaoqing Chai, Rong Jiang, Ping Zhao, Jiaqiang Zhang and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC anesthesiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05111431 (Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05111431 phase3completednot on this map

Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children

TypeinterventionalSponsorShanghai Hengrui Pharmaceutical Co., Ltd.Ran2021 to 2022Enrolled159ConditionsPreoperative Sedation of ChildrenArmsDexmedetomidine Hydrochloride Nasal Spray, Dexmedetomidine hydrochloride nasal spray blank preparation
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Jia GaoDepartment 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.
Fang WangDepartment 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.
Xiaoling WangDepartment of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.
Xiaohua ZouDepartment of Anesthesiology, the Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Hua-Cheng LiuDepartment of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, China.
Xingrong SongDepartment of Anesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Xiaoqing ChaiDepartment of Anesthesiology, Anhui Provincial Hospital, Hefei, China.
Rong JiangDepartment of Anesthesiology, Sichuan Provincial People's Hospital, Chengdu, China.
Ping ZhaoDepartment of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, China.
Jiaqiang ZhangDepartment of Anesthesiology and Perioperative Medicine, Henan Provincial People's Hospital, Zhengzhou, China.
Sai-Ying WangDepartment of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, China.
Haichun MaDepartment of Anesthesiology, The First Hospital of Jilin University, Changchun, China.
Zhibin ZhaoDepartment of Anesthesiology, The First People's Hospital of Lianyungang, Lianyungang, China.
Quanren WangJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Na ZhouJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Jianling BaiDepartment of Biostatistics, School of Public Heath, Nanjing Medical University, Nanjing, Jiangsu, China.
Jianmin ZhangDepartment 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. zhangjianmin@bch.com.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOff-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.

objectiveTo evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children.

methodsThe 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.

resultsThe 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.

conclusionsThis novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.

Indexed as

DexmedetomidineHypnotics and SedativesNasal SpraysAdministration, IntranasalChildChild, PreschoolChinaDouble-Blind MethodFemaleHumansMalePreanesthetic MedicationDexmedetomidineHypnotics and SedativesNasal SpraysDexmedetomidineIntranasalPediatricPre-anestheticSedation

Identifiers

PMID39242499
PMCPMC11378629

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.