Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial

IF 3.4 2区医学 Q1 ANESTHESIOLOGY

European Journal of Pain Pub Date : 2025-08-05 DOI:10.1002/ejp.70096

Stefano Maiandi, Sergio Coluccia, Greta Ghizzardi, Romana Nicardi, Roberta Giacchero, Maura Lusignani, Maria Lorella Giannì, Valeria Carla Edefonti

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Abstract

Background

Children undergoing painful procedures often experience distress and anxiety, impacting their cooperation and perception of healthcare. This study evaluates the effectiveness of combining Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) with audiovisual distraction (experimental group) versus EMONO only (control group) to improve cooperation and reduce pain during peripheral venous catheter (PVC) placement.

Methods

The first 120 eligible children 2–5 years old and requiring PVC placement were enrolled. Sixty children were randomly assigned to the experimental group and 60 to the control group. Cooperation and pain were assessed by employing validated tools throughout the procedure. The presence of side effects was also investigated as a secondary outcome.

Results

Among the 120 recruited children, 46.7% were males and the mean age ± SD was 3.35 ± 1.11 years. In univariate analyses, no differences between the groups were detected for socio-demographic and clinical variables; in the experimental group, a significantly increased cooperation during the procedure and a reduced pain were observed (p < 0.01). In logistic regression models, children receiving the experimental treatment were more than 15-fold likely to collaborate (OR = 17.0, p < 0.01) and less likely to perceive more than mild pain (OR = 0.22, p < 0.01). Older children were more likely to collaborate (OR = 1.65, p < 0.02) and to be less prone to experience serious or worse levels of pain (OR = 0.51, p = 0.005). The experimental treatment was associated with reduced vomiting episodes in univariate models only.

Conclusion

The combination of audiovisuals with EMONO may be effective in increasing cooperation and reducing pain in children 2–5 years during PVC placement.

Significance Statement

Children often experience pain during illness-related procedures, such as peripheral venous catheter placement. EMONO is recognised for its effectiveness in reducing pain and enhancing cooperation. Additionally, audiovisual distraction techniques are employed to divert children's attention during medical procedures. Our study addresses a gap in knowledge regarding cooperation, pain and symptom management by utilising a non-pharmacological, safe and easily accessible technique—watching audiovisuals. This approach is particularly relevant for a population that is underrepresented in the literature.

Trial Registration

ClinicalTrials.gov identifier: NCT05435118

查看原文本刊更多论文

等摩尔氧和氧化亚氮混合物结合视听治疗幼儿的有效性：一项随机对照试验

经历痛苦手术的儿童通常会感到痛苦和焦虑，影响他们的合作和对医疗保健的看法。本研究评估了等摩尔氧和一氧化二氮混合物（EMONO）联合视听分散（实验组）与EMONO（对照组）在外周静脉导管（PVC）放置过程中改善合作和减轻疼痛的有效性。方法选取120例符合条件的2 ~ 5岁需要植入术的患儿。60名儿童随机分为实验组和对照组。在整个手术过程中使用经过验证的工具评估合作和疼痛。副作用的存在也作为次要结果进行了调查。结果120例患儿中，男性占46.7%，平均年龄±SD为3.35±1.11岁。在单变量分析中，未发现社会人口统计学和临床变量在组间的差异；在实验组中，观察到手术过程中合作程度显著提高，疼痛减轻（p < 0.01）。在logistic回归模型中，接受实验治疗的儿童合作的可能性超过15倍（OR = 17.0, p < 0.01），并且不太可能感受到超过轻微的疼痛（OR = 0.22, p < 0.01）。年龄较大的儿童更有可能合作（OR = 1.65, p < 0.02），更不容易经历严重或更严重的疼痛（OR = 0.51, p = 0.005）。仅在单变量模型中，实验治疗与呕吐发作减少有关。结论视听结合EMONO可有效提高2 ~ 5岁儿童PVC置入术中的配合度，减轻疼痛。意义声明儿童在疾病相关的手术过程中经常感到疼痛，例如外周静脉导管置入。EMONO在减轻疼痛和加强合作方面的有效性得到了认可。此外，在医疗过程中，视听分散技术被用来转移儿童的注意力。我们的研究通过使用一种非药物的、安全的、容易获得的技术——观看视听，解决了在合作、疼痛和症状管理方面的知识差距。这种方法特别适用于文献中代表性不足的人群。试验注册ClinicalTrials.gov标识符：NCT05435118

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来源期刊

European Journal of Pain 医学-临床神经学

CiteScore

7.50

自引率

5.60%

发文量

163

审稿时长

4-8 weeks

期刊介绍： European Journal of Pain (EJP) publishes clinical and basic science research papers relevant to all aspects of pain and its management, including specialties such as anaesthesia, dentistry, neurology and neurosurgery, orthopaedics, palliative care, pharmacology, physiology, psychiatry, psychology and rehabilitation; socio-economic aspects of pain are also covered. Regular sections in the journal are as follows: • Editorials and Commentaries • Position Papers and Guidelines • Reviews • Original Articles • Letters • Bookshelf The journal particularly welcomes clinical trials, which are published on an occasional basis. Research articles are published under the following subject headings: • Neurobiology • Neurology • Experimental Pharmacology • Clinical Pharmacology • Psychology • Behavioural Therapy • Epidemiology • Cancer Pain • Acute Pain • Clinical Trials.