Evidence map›Paper›PMID 35129802›Full record

ArticleNeurology and therapy2022

Bioavailability and Safety of a New Highly Concentrated Midazolam Nasal Spray Compared to Buccal and Intravenous Midazolam Treatment in Chinese Healthy Volunteers.

Hui Wang, Jie Huang, Shuang Yang, Xing-Fei Zhang, Xiaoyan Yang, Chang Cui, Chan Zou, Li-E Li, Min Zhang, Miao-Fu Mao and 4 more

Open access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
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

14 authors at 2 institutions in 1 country.

Hui Wang *Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Jie Huang *Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Shuang YangCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Xing-Fei ZhangCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Xiaoyan YangCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Chang CuiCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Chan ZouCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Li-E LiYichang Renfu Pharmaceutical Co., Ltd., Yichang, 443000, Hubei, China.
Min ZhangYichang Renfu Pharmaceutical Co., Ltd., Yichang, 443000, Hubei, China.
Miao-Fu MaoYichang Renfu Pharmaceutical Co., Ltd., Yichang, 443000, Hubei, China.
Xiang ZhouYichang Renfu Pharmaceutical Co., Ltd., Yichang, 443000, Hubei, China.
Kai-Ming DuanDepartment of Anesthesiology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Sai-Ying WangDepartment of Anesthesiology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China. 1771303488@qq.com.
Guo-Ping YangCenter for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China. ygp9880@126.com.ORCID http://orcid.org/0000-0001-5930-586X
Central South University · CNSecond Hospital of Yichang · CN

Funding

Natural Science Foundation of Hunan Province 2020JJ5852Natural Science Foundation of Hunan Province 2021JJ31022the National Major new drug creation project of China 2020ZX09201010
6 · The paper itself

Abstract

introductionBuccal midazolam treatment is licensed in the European Union for prolonged acute convulsive seizures in children and adolescents, but the buccal pathway is often hampered by jaw clenching, hypersalivation, or uncontrolled swallowing. Midazolam formulations that are more secure, reliable, and faster for use are needed in the acute setting. Pharmacokinetics and comparative bioavailability of intranasally administered midazolam and two midazolam intravenous solutions administered buccally or intravenously in healthy adults were evaluated.

methodsIn this phase 1, open-label, randomized, single-dose, three-period, three-sequence crossover study, 12 healthy adults (19-41 years) were randomly assigned to receive 2.5 mg midazolam intranasally; 2.5 mg midazolam intravenously; 2.5 mg midazolam buccally. Blood samples were collected for 10 h post dose to determine pharmacokinetic profiles. Adverse events and vital signs were recorded.

resultsIntranasal administration of 2.5 mg midazolam demonstrated a more rapid median time to C

conclusionIntranasal administration of midazolam may be a preferable alternative to the currently approve buccal midazolam treatment for prolonged acute convulsive seizures in children and adolescents.

trial registrationThis study is registered at the Chinese Clinical Trial [ http://www.chictr.org.cn ] (ChiCTR2000032595) on 3 May, 2020.

Indexed as

BioavailabilityBuccal midazolamIntravenous midazolamMidazolamNasal spraySafety

Identifiers

PMID35129802
PMCPMC9095771
OpenAlexW4210874910

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.