Opioid Analgesia Impacts on Neurological Development
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-12
SponsorUniversity of Nottingham
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Opioid exposure
Trial outcomes
Primary outcomes
1
Beta oscillations
Beta oscillations in response to attentional tasks as measured by OPM-MEG
Time frame
BaselineSecondary outcomes
1
Disability
Childhood Health Assessment Questionnaire (CHAQ) a validated questionnaire to measure disability in children
Time frame
Baseline2
Anxiety and Depression
Revised Child anxiety and Depression scale - a validated questionnaire to assess anxiety and depression in children
Time frame
Baseline3
Pain-related worrying
Pain Catastrophizing Scale (PCS) is a valid questionnaire assessing pain-related worrying
Time frame
Baseline4
Post-traumatic-sress
Child Post Traumatic Stress Disorder symptoms scale is a valid questionnaire to assess childhood post traumatic stress disorder related symptoms
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: