Opioid Analgesia Impacts on Neurological Development (OPAL)

September 28, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beta oscillations
Time Frame: Baseline

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Baseline

Childhood Health Assessment Questionnaire (CHAQ) a validated questionnaire to measure disability in children
Baseline
Anxiety and Depression
Time Frame: Baseline

Revised Child anxiety and Depression scale - a validated questionnaire to assess anxiety and depression in children
Baseline
Pain-related worrying
Time Frame: Baseline

Pain Catastrophizing Scale (PCS) is a valid questionnaire assessing pain-related worrying
Baseline
Post-traumatic-sress
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ben Marson, MB BCh BSc PhD FRCS, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 367270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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