NCT06869928 Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices
| NCT ID | NCT06869928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Pain and Irritability of Unknown Origin (PIUO) Pathway is a clinical pathway that was developed to evaluate and manage unexplained pain and irritability for children with severe neurological impairments (SNI) who cannot verbally communicate 'where it hurts'. The investigators studied the usefulness of the Pathway with families and expert clinicians in 4 centres across Canada. The aim of this Phase 2 study is to determine whether this tool can transfer from hospital research centres into the community. The Pathway will be used by community pediatricians across British Columbia (BC) when they see patients with PIUO. The investigators want to know how well these pediatricians can follow the Pathway. The goal is to create a systematic, cohesive approach to enhance the clinical care for all children with complex medical needs experiencing PIUO.
Eligibility 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)
Contact & Investigator
Hal Siden, MD
PRINCIPAL INVESTIGATOR
University of British Columbia and BC Children's Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06869928 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 18 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06869928 currently recruiting?
Yes, NCT06869928 is actively recruiting participants. Contact the research team at sharon.hou@bcchr.ca for enrollment information.
Where is the NCT06869928 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT06869928 clinical trial?
NCT06869928 is sponsored by University of British Columbia. The principal investigator is Hal Siden, MD at University of British Columbia and BC Children's Hospital Research Institute. The trial plans to enroll 20 participants.