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探索小儿口腔外科中的清醒镇静:一项关于安全性和有效性的非随机临床试验。

Exploring Conscious Sedation in Pediatric Oral Surgery: A Non-Randomized Clinical Trial on Safety and Efficacy.

作者信息

Cenzato Niccolò, Pasquali Lorenzo, Menozzi Gregorio, Maspero Cinzia

机构信息

Department of Biomedical, Surgical and Dental Sciences, School of Dentistry, University of Milan, 20122 Milan, Italy.

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Maxillo-Facial Surgery and Dental Unit, Via Sforza 35, 20122 Milan, Italy.

出版信息

Children (Basel). 2025 May 5;12(5):604. doi: 10.3390/children12050604.

DOI:10.3390/children12050604
PMID:40426783
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12110325/
Abstract

BACKGROUND

Conscious sedation is a well-established technique used in pediatric dentistry that reduces perioperative stress and pain while maintaining verbal contact with the patient. It is particularly beneficial for anxious, very young, or disabled children, improving cooperation and ensuring airway safety. The objective of this study is to assess the safety and efficacy of conscious sedation in pediatric oral surgery by analyzing vital parameters before and after treatment.

METHODS

A total of 57 pediatric patients [29 females; 28 males], aged 5-14 years [mean: 9.4], were treated at the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan between September 2022 and June 2024. The patients were divided into two groups: nitrous oxide sedation [Group A] and benzodiazepine sedation [Group B]. Informant consent, medical and dental history, vital signs, and anxiety levels were recorded. A statistical analysis was performed using the Wilcoxon test. Due to the non-randomized design of this study, potential selection bias and limitations in internal validity must be acknowledged.

RESULTS

The post-sedation diastolic pressure was significantly higher [ = 0.02] in Group b, while other vital parameters remained stable. Anxiety significantly decreased in both groups [ < 0.01], with a greater reduction in Group A.

CONCLUSIONS

Conscious sedation is a safe and effective approach, maintaining stable vital parameters. The increase in diastolic pressure in Group B may be explained by preexisting anxiety and benzodiazepine pharmacodynamics. However, the absence of randomization may have influenced group allocation and outcome interpretation. Given the small sample size and the wide age range of the participants, further studies with larger and more homogeneous populations are necessary to refine and validate pediatric sedation protocols.

摘要

背景

清醒镇静是儿科牙科中一种成熟的技术,可减轻围手术期的压力和疼痛,同时保持与患者的语言交流。它对焦虑、年幼或残疾儿童特别有益,可提高合作度并确保气道安全。本研究的目的是通过分析治疗前后的生命体征参数来评估清醒镇静在儿童口腔外科手术中的安全性和有效性。

方法

2022年9月至2024年6月期间,米兰的 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico 共治疗了57例5至14岁的儿科患者(29名女性;28名男性,平均年龄9.4岁)。患者被分为两组:一氧化二氮镇静组(A组)和苯二氮䓬镇静组(B组)。记录了知情同意书、病史和牙科病史、生命体征以及焦虑水平。使用 Wilcoxon 检验进行统计分析。由于本研究的非随机设计,必须承认存在潜在的选择偏倚和内部效度的局限性。

结果

B组镇静后的舒张压显著升高(P = 0.02),而其他生命体征参数保持稳定。两组的焦虑均显著降低(P < 0.01),A组降低幅度更大。

结论

清醒镇静是一种安全有效的方法,可维持生命体征参数稳定。B组舒张压升高可能是由于既往焦虑和苯二氮䓬的药效学作用。然而,缺乏随机分组可能影响了组间分配和结果解释。鉴于样本量小且参与者年龄范围广,有必要进行更大规模、更同质人群的进一步研究,以完善和验证儿科镇静方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/595e1d4e707d/children-12-00604-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/b340121441e0/children-12-00604-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/55e502b22615/children-12-00604-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/81136d037fc6/children-12-00604-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/a7e5a33e4470/children-12-00604-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/6de25622668b/children-12-00604-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/595e1d4e707d/children-12-00604-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/b340121441e0/children-12-00604-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/55e502b22615/children-12-00604-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/81136d037fc6/children-12-00604-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/a7e5a33e4470/children-12-00604-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/6de25622668b/children-12-00604-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d440/12110325/595e1d4e707d/children-12-00604-g006.jpg

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