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Not Yet Recruiting NCT07855952

Opioid Analgesia Impacts on Neurological Development

Conditions: Fracture, Scoliosis Idiopathic Adolescent, Traumatic Injury, Adolescent, Dislocation

Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: University of Nottingham

Location: University of Nottingham Nottingham

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. 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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07855952). StuddyBuddy aggregates publicly available trial information.