Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT06869928

Conditions

Pain

Irritability

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

PIUO Pathway

Study Details

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.

Conditions

Pain

Irritability

Neuropathic Pain

Study ID

NCT06869928

Start date

Jun 28, 2024

Status verified date

Mar, 2025

Completion date

May, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: PIUO Pathway

The PIUO Pathway targets PIUO in an intentional, focused, timely, sequential order of standardized steps to support best outcomes for children with SNI and families.

The PIUO Pathway is comprised of 2 steps. Step 1 is for the pediatrician to conduct a thorough history that includes a pain history to identify known and unknown sources of past and current pain, and a physical examination. Step 2 is to carry out a series of screening tests to further explore any potential underlying disease or injury if not apparent based on the Step 1 history and physical examination. The standard screening tests may include urinalysis, ultrasound, gastric pH, and bloodwork. Each child proceeds through the Pain Pathway as long as their pain persists but may not go through all steps if their pain source is identified or pain resolves at any stage. The Steps of the Pain Pathway may be refined by the team based on the results of Phase 1 study analysis, which is underway.

Interventions

PIUO Pathway

see arm description.

Primary outcome measure

  • Implementation Adoption [ Time Frame: End of the Pain Pathway, an average of 1 year to 18 months ]
  • Implementation Reach [ Time Frame: Baseline and end of the Pain Pathway, an average of 1 year to 18 months ]
  • Implementation Acceptability [ Time Frame: End of the Pain Pathway, an average of 1 year to 18 months ]
  • PIUO Pain Pathway Effectiveness [ Time Frame: End of the Pain Pathway, an average of 1 year to 18 months ]

Central Contacts and Locations

Central contacts

Sharon Hou, PhD

604-875-2345sharon.hou@bcchr.ca

Anne-Mette Hermansen, MA

604-875-2000ahermansen@bcchr.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

More Information

Sponsor

University of British Columbia

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • Pain
  • Irritability
  • Pediatrics
  • Community
  • Neuropathic Pain
  • Severe Neurological Disabilities
  • Implementation Science
  • Patient Engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-03-11.