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一项关于小儿术后持续性疼痛的前瞻性观察研究,4P:研究方案。

A prospective observational study on persistent postoperative pediatric pain, 4P: The study protocol.

作者信息

Broman Johanna, Nielsen Niklas, Persson Anna K M

机构信息

Department of Anesthesiology and Intensive Care, Helsingborg Lasarett, Helsingborg, Sweden.

Department of Clinical Sciences Helsingborg, Lund University, Helsingborg, Sweden.

出版信息

PLoS One. 2025 Jan 14;20(1):e0316533. doi: 10.1371/journal.pone.0316533. eCollection 2025.

Abstract

BACKGROUND

Access to adequate pain treatment is a fundamental right, yet international data suggest that a considerable number of children experience acute and persistent pain. Little is known about the occurrence of both acute and persistent pain in children. The incidence of persistent postoperative pain in children is an unexplored area but international studies suggest that many children experience long-term pain after surgery, with a major impact on daily life. In 4P, Persistent Postoperative Pediatric Pain, we want to estimate the incidence of acute and persistent postoperative pediatric pain. The European Society for Paediatric Anaesthesiology has developed guidelines for perioperative pain management. We aim to examine how well these guidelines are followed and whether adherence to guidelines influences the pain experienced after surgery.

METHOD

4P is a prospective observational study of children aged 1-17, planned for surgery in southern Sweden 2023-2024. After agreement from all caregivers, data concerning preoperative pain, pre-emptive analgesia, perioperative management and postoperative pain will be collected. Via an electronic management software, pain will be evaluated at home (or in hospital) at 24h, 3, 6 and 12 months after surgery. We will include 1000 patients.

DISCUSSION

4P will prospectively follow a large number of children after general pediatric surgeries and evaluate the occurrence of postoperative pain, both acute (APOP) and persistent (PPOP). The study will assess pain treatment regimens and identify risk factors associated with the development of acute and persistent pediatric postoperative pain.

TRIAL REGISTRATION

Prospectively posted at ClinicalTrials.gov, identifier NCT06035042.

摘要

背景

获得充分的疼痛治疗是一项基本权利,但国际数据表明,相当数量的儿童经历急性和持续性疼痛。对于儿童急性和持续性疼痛的发生情况知之甚少。儿童术后持续性疼痛的发生率是一个尚未探索的领域,但国际研究表明,许多儿童术后会经历长期疼痛,这对日常生活有重大影响。在“4P——儿童术后持续性疼痛”研究中,我们希望估计儿童急性和术后持续性疼痛的发生率。欧洲儿科麻醉学会已制定围手术期疼痛管理指南。我们旨在研究这些指南的遵循情况,以及遵循指南是否会影响术后疼痛体验。

方法

“4P”是一项对1至17岁儿童的前瞻性观察性研究,计划于2023 - 2024年在瑞典南部进行手术。在所有护理人员同意后,将收集有关术前疼痛、预防性镇痛、围手术期管理和术后疼痛的数据。通过电子管理软件,将在术后24小时、3个月、6个月和12个月在家中(或医院)评估疼痛情况。我们将纳入1000名患者。

讨论

“4P”将对大量儿童进行普通儿科手术后的前瞻性随访,并评估术后疼痛的发生情况,包括急性疼痛(APOP)和持续性疼痛(PPOP)。该研究将评估疼痛治疗方案,并确定与儿童急性和持续性术后疼痛发展相关的风险因素。

试验注册

前瞻性地发布在ClinicalTrials.gov上,标识符为NCT06035042。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a99/11731717/16c407c04972/pone.0316533.g001.jpg

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