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Opioid Analgesia Impacts on Neurological Development (OPAL)

2026年9月28日 更新者:University of Nottingham

The Long-term Impact of Opioid Analgesia in Children and Young People on Long-term Neurological Development.

Background: Pain in childhood - whether from injuries like fractures or long-term conditions like scoliosis - is often treated with opioid medicines. These drugs are effective for pain relief. Recent research suggests that they may affect brain development if given during key stages of growth. This study will explore how different types of pain and opioid use impact brain activity in children using a child-friendly brain scan called OPM-MEG.

Objectives:

  1. To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles.
  2. To investigate the relationships between brain activity and clinical features, including subjective pain ratings, pain sensitivity, and psychological outcomes (e.g. trauma symptoms, distress).

Participants will be asked to attend a single visit, which may coincide with their follow-up clinical appointment to orthopaedics or at an alternative convenient time. The visit will take approximately 1-1.5 hours and consist of recording brain activity using the child-friendly OPM-MEG (like a bicycle helmet) during rest and in response to a variety of sensory stimuli. Participants will also be asked to complete a small number of questionnaires.

研究概览

地位

尚未招聘

条件

详细说明

In the orthopaedic clinic Parents of children aged 7-12 years will be screened for the study from the usual care team provided with a participant information sheet and invitation letter. Potential participants will be approached by a member of the research team at a subsequent follow up appointment for recruitment into the study. All participants will provide informed consent signed by the parent or guardian in the clinic room upon recruitment by a member of the research staff. Children (aged 7-12) will sign to confirm assent. Parents/guardians will be given a form to fill in their contact details, and a validated age appropriate questionnaire to complete before the study appointment. [The Multisensory Amplification Scale (Dan Wang and Megan Loux, 2022) will asses the participants sensory processing. The Revised Child Anxiety and Depression Scale (RCADS) (Chorpita et al., 2005) will assess the participants' anxiety and depression.]

At home An appointment letter will be emailed or posted to the participants, in line with their preferred contact method. A reminder text message will be sent a few days prior to their appointment. Participants will have a study appointment arranged on the same day as their follow-up appointment to orthopaedics or at an alternative convenient time. The participants will complete the questionnaire with the help of their parent/guardian at home before the study appointment. This will take roughly 20-30 minutes, including schedules breaks.

Study appointment At the research visit, children will attend the Sir Peter Mansfield Imaging Centre (SPMIC) at the University of Nottingham for an appointment 1-1.5 hours (allows for technical difficulties). The OPM-MEG is integrated into a helmet (effectively a modified bicycle helmet). The child will wear this helmet throughout the scanning session, and this will allow the passive measurement of MEG data.

We will use OPM-MEG to record brain activity during rest (tactile-free) and in response to a tactile and visual stimuli.

The tactile attention task involves brief, gentle stimulation to the index fingers using braille-style devices while the participant watches a video of their choice. Stimulation is delivered using a set of custom-built braille cells mounted on a wooden platform, allowing for comfortable and stable hand placement. A single trial comprised approximately 0.5s of stimulation during which the finger is tapped 3 times using all 8 pins. Pins are up for 82ms during each 'tap' and down for 82ms between 'taps'). This is followed by 3 s rest. The finger stimulates the index finger. There is a total of 42 trials for each finger, meaning the experiment lasts a total of 294 seconds (5 minutes).

The visual stimulation to measure gamma activity comprises of an inwardly moving circular grating moving at 1.2°s-1. The grating is displayed centrally at 100% contrast and subtended a visual angle of 7.6°, with 1.32 cycles per degree. A single trial comprises 1000 ms of stimulation followed by a jittered rest period with a white fixation cross located centrally on a black screen for 1250 ± 200 ms. Sixty trials in total are shown and these circles trials are interspersed with images of faces. The total time for this task is roughly 5 minutes.

All devices have been safety tested for use with human volunteers and pose no risk to the participants, and are well tolerated. At all times the child's parent/guardian will remain in the study room with them. The experimenter and parent/guardian can communicate via an intercom set-up, ensuring the comfort of the child and parent throughout the study. Participants will also be continuously monitored on a video camera within the scanning suite. If the child becomes distressed at any point the study will be stopped, and only restarted if both the parent/guardian and their child are happy. The child will also be able to watch a TV program/film during the study to ensure that they remain comfortable.

A typical recording session will last approximately 40 minutes allowing for technical difficulties. It will consist of:

  • Two 5 minute recording blocks and one 5-10 minute resting state recording block. The participant will be watching a standardised video on screen for both tasks and resting state recording.
  • We will need to record the shape of the child's head- this will be done using an Einscan. This creates a 3D image of the head with, and without the helmet on to accurately record the locations of the sensors on the scalp.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Individuals adolescents (aged 7-12 years old) who have recently, in the past 8 weeks, had a musculoskeletal intervention (e.g. traumatic injury, long bone fracture, scoliosis correction) requiring the administration of opiate medication as part of routine care.

描述

Inclusion Criteria:

  • Individuals aged 7-12 years
  • Had a recent (within 8 weeks) musculoskeletal intervention (e.g. traumatic injury, long bone fracture, scoliosis correction) requiring administration of opioids by their clinical care team
  • Parent/guardian who can give informed consent on behalf of the child

Exclusion Criteria:

  • Terminal/uncontrolled medical or mental health conditions that would prevent them from completing the study assessments or pose a significant risk to participants or staff
  • Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
  • Inability to adhere to the study protocol
  • Taken opiate medication in the last 7 days
  • Epilepsy
  • Cerebral Palsy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
Opioid exposure

Individuals aged 7-12 years old with exposure to opiate medication for musculoskeletal intervention, e.g. traumatic injury, long bone fracture, scoliosis correction)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Beta oscillations
大体时间:Baseline

Beta oscillations in response to attentional tasks as measured by OPM-MEG

Baseline

次要结果测量

结果测量
措施说明
大体时间
Disability
大体时间:Baseline

Childhood Health Assessment Questionnaire (CHAQ) a validated questionnaire to measure disability in children

Baseline
Anxiety and Depression
大体时间:Baseline

Revised Child anxiety and Depression scale - a validated questionnaire to assess anxiety and depression in children

Baseline
Pain-related worrying
大体时间:Baseline

Pain Catastrophizing Scale (PCS) is a valid questionnaire assessing pain-related worrying

Baseline
Post-traumatic-sress
大体时间:Baseline

Child Post Traumatic Stress Disorder symptoms scale is a valid questionnaire to assess childhood post traumatic stress disorder related symptoms

Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Ben Marson, MB BCh BSc PhD FRCS、University of Nottingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 367270

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

This is pilot data for a larger clinical study. No data will be shared until the larger study is complete

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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