Using a new pathway to manage unexplained pain in children with severe neurological impairments
Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices
This study is testing a new way for doctors to help manage unexplained pain in children with severe neurological impairments who can't tell us how they feel.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06869928 on ClinicalTrials.gov |
What this trial studies
This study implements the Pain and Irritability of Unknown Origin (PIUO) Pathway in community pediatric practices to evaluate and manage unexplained pain and irritability in children with severe neurological impairments who cannot communicate their pain. The pathway, previously used in specialized hospital settings, aims to train community pediatricians in British Columbia to effectively utilize this tool. By enhancing the clinical care for these vulnerable children, the study seeks to create a systematic approach to pain management that can be sustained in community settings. The research will assess the feasibility and effectiveness of this implementation.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 months to 18 years with severe neurological impairments who experience unexplained pain and irritability and cannot communicate their pain.
Not a fit: Patients who can localize their pain or have a known and treatable cause of pain will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for children with severe neurological impairments.
How similar studies have performed: While the PIUO Pathway has been effective in specialized settings, this implementation in community practices is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Pain Pathway Intervention Inclusion Criteria: * Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate. * Eligible children will have cognitive impairment or be non-verbal. Parents should have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools. Pain Pathway Intervention Exclusion Criteria: * Children not within the specified age range * Children with communication capabilities and cognitive development to localize their pain * Children that have an explained and treatable cause of pain and irritability. Parents that do not have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools. Implementation Participant Inclusion Criteria: * General pediatricians * Practicing in a community clinic in British Columbia Implementation Participant Exclusion Criteria: \- Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)
Where this trial is running
Vancouver, British Columbia
- BC Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Hal Siden, MD — University of British Columbia and BC Children's Hospital Research Institute
- Study coordinator: Sharon Hou, PhD
- Email: sharon.hou@bcchr.ca
- Phone: 604-875-2345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.