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Pain and Irritability in Non-Verbal Children

NCT03464773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-05-08

No results posted yet for this study

Summary

Children born with severe brain-based developmental disabilities frequently experience persistent unexplained periods of pain and irritability, often compounded by a limited capacity to communicate their distress. The investigators call this entity Pain and Irritability of Unknown Origin (PIUO). The investigators have designed a systematic approach, called the PIUO Pathway, to address the management of these children's pain and irritability with the goals of reducing pain symptoms, improving the day-to-day lives of the child and family, and simplifying treatment options for clinicians.

Conditions

  • Pain
  • Neuropathic Pain
  • Irritability

Interventions

OTHER

PIUO Pathway

See arm descriptions

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Calgary

    collaborator OTHER

  • University of Ottawa

    collaborator OTHER

  • Provincial Health Services Authority

    collaborator OTHER

  • Alberta Children's Hospital

    collaborator OTHER

  • Children's Hospital of Eastern Ontario

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Hal Siden, MD · BC Children's Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03464773 on ClinicalTrials.gov