Opioid Analgesia Impacts on Neurological Development

NCT07855952 | Not Yet Recruiting

• 1 other identifier: 367270
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.To compare brain activity patterns in different regions of the brain in children with different pain and opioid exposure profiles.
2. 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).

Conditions

Fracture; Scoliosis Idiopathic Adolescent; Traumatic Injury; Adolescent; Dislocation

Keywords

Brain Imaging; Opioid; Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• Beta oscillations

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

  Baseline

Secondary Outcomes (4)

• Disability

  Baseline

• Anxiety and Depression

  Baseline

• Pain-related worrying

  Baseline

• Post-traumatic-sress

  Baseline

Study Arms (1)

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)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 UH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ben Marson, MB BCh BSc PhD FRCS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Smith, BSc (Hons), MRes, PhD, PGCHE

CONTACT

+44115 823 1942; Stephanie.Smith2@Nottingham.ac.uk

Gareth Hathway, PhD

CONTACT

+441158230152; gareth.hathway@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion: September 30, 2026
• Study Completion: September 30, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

GB (1)