Status:
COMPLETED
Pain and Irritability in Non-Verbal Children
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Calgary
Conditions:
Pain
Neuropathic Pain
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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 th...
Detailed Description
The purpose of this project is to develop, test, and disseminate an approach to reducing and resolving pain in children with developmental brain disorders, specifically those with severe neurological ...
Eligibility Criteria
Inclusion
- 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 and have severe levels of disability equivalent to Gross Motor Functional Classification System (GMFCS) scores of 3, 4 or 5.
- Eligible children will score \>3 on two scales administered via an Eligibility Screening that measures persistence and distress level the child is experiencing as well as identifies the type of pain and irritability as PIUO - with no obvious cause or explanation. The score of \>3 on the scale measuring pain persistence and distress level confirms that the child is experiencing pain and irritability more than "a little" on "some days".
- Parents should have sufficient English/French language skill, or have access to assistance, to participate in the clinic visits and complete survey tools.
Exclusion
- 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 who do not speak one of Canada's two official languages (English or French)
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03464773
Start Date
April 15 2018
End Date
July 31 2023
Last Update
May 8 2024
Active Locations (1)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4