Evidence map›Paper›PMID 37957769›Full record

ArticleTrials2023

Comparison of S-ketamine and midazolam for intravenous preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled clinical trial.

Meng-Qiu Zhang, Ming-Zhe Xu, Yi He, Yong-Wei Su, Jun Ma, Yun-Xia Zuo

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
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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

6 authors at 2 institutions in 1 country.

Meng-Qiu ZhangDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Ming-Zhe XuDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Yi HeDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Yong-Wei SuDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Jun MaDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Yun-Xia ZuoDepartment of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China. zuoyunxia@scu.edu.cn.
West China Hospital of Sichuan University · CNSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreoperative anxiety management is gaining particular attention in paediatric anaesthesia. Pharmacological and non-pharmacological resorts can be implemented to address this special issue. Despite the various approaches currently used for preoperative sedation in children, the different sedative and anti-anxiety effects between the newly marketed anaesthetic, S-ketamine, and the traditional sedative, midazolam, are still unclear.

methodsThis is a patient- and assessor-blinded randomized controlled clinical trial. Participants (n = 110) will receive S-ketamine (0.5 mg/kg) or midazolam (0.08 mg/kg) intravenously administrated at a ratio of 1:1 in the anaesthesia holding area. The primary outcome of this study is the sedative effect evaluated via the change in the modified Yale preoperative anxiety scale. It will be performed at two timepoints: in the pre-anaesthetic holding area before premedication (baseline, marked as T0) and about 5 min after premedication in the operating room without the existence of their guardians (marked as T1). Our secondary objectives include the parent separation anxiety score, postoperative agitation, caregivers' and anaesthesia care providers' satisfaction, and mask compliance. DISCUSSION: This randomized controlled trial is the first study to compare the anti-anxiety effect of intravenous S-ketamine and midazolam. We will provide a new approach for the clinical management of preoperative anxiety in preschool children posted for elective surgery.

trial registrationChiCTR2300069998. Registered on 30 March 2023.

Indexed as

AnestheticsAnti-Anxiety AgentsChild, PreschoolDouble-Blind MethodHumansHypnotics and SedativesKetamineMidazolamRandomized Controlled Trials as TopicAnestheticsAnti-Anxiety AgentsEsketamineHypnotics and SedativesKetamineMidazolamMidazolamPreschool childrenRandomized controlled trialS-ketamine

Identifiers

PMID37957769
PMCPMC10644481
OpenAlexW4388626985

What OpenQuestion holds

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Registered trials

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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.