FractureOPALNCT07855952
Opioid Analgesia Impacts on Neurological Development
An observational study of Fracture and Scoliosis Idiopathic Adolescent, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Fracture, Scoliosis Idiopathic Adolescent, Traumatic Injury
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie Smith, BSc (Hons), MRes, PhD, PGCHE contact
United Kingdom1 site
University of Nottingham
Nottingham, NG7 UH
Ben Marson, MB BCh BSc PhD FRCS, 000, ben.marson@Nottingham.ac.uk
Gareth Hathway, PhD, +441158230152, gareth.hathway@nottingham.ac.uk
About this study
Official title: 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:
Read more
- To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles.
- 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.
Read the 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.
- Keywords
- Brain Imaging, Opioid, Musculoskeletal
- Medical subject headings
- Fractures, Bone, Wounds and Injuries, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Beta oscillations
Beta oscillations in response to attentional tasks as measured by OPM-MEG
Measured: Baseline
Secondary outcomes (4)
Disability
Childhood Health Assessment Questionnaire (CHAQ) a validated questionnaire to measure disability in children
Measured: Baseline
Anxiety and Depression
Revised Child anxiety and Depression scale - a validated questionnaire to assess anxiety and depression in children
Measured: Baseline
Pain-related worrying
Pain Catastrophizing Scale (PCS) is a valid questionnaire assessing pain-related worrying
Measured: Baseline
Post-traumatic-sress
Child Post Traumatic Stress Disorder symptoms scale is a valid questionnaire to assess childhood post traumatic stress disorder related symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben Marson, MB BCh BSc PhD FRCS, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855952
- Sponsor's protocol ID
- 367270
- Acronym
- OPAL
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is pilot data for a larger clinical study. No data will be shared until the larger study is complete
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Impact of Opioid Analgesia in Children and Young People on Long-term Neurological Development.
- ClinicalTrials.gov ID
- NCT07855952
- Acronym / sponsor ID
- OPAL / 367270
- Keywords
- Brain Imaging, Opioid, Musculoskeletal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beta oscillations
Time frame: Baseline
Beta oscillations in response to attentional tasks as measured by OPM-MEG
4 secondary outcomes
Disability
Time frame: Baseline
Anxiety and Depression
Time frame: Baseline
Pain-related worrying
Time frame: Baseline
Post-traumatic-sress
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided. This is pilot data for a larger clinical study. No data will be shared until the larger study is complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Smith, BSc (Hons), MRes, PhD, PGCHE contact
Ben Marson, MB BCh BSc PhD FRCS principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture and Scoliosis Idiopathic Adolescent, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Smith, BSc (Hons), MRes, PhD, PGCHE (+44115 823 1942, Stephanie.Smith2@Nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta oscillations (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.