Pain Clinical Trial
— PIUOOfficial title:
Optimizing the Management of Pain and Irritability of Unknown Origin (PIUO) in Children With Severe Neurological Impairment
Verified date | October 2021 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 120 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | 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 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 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 who do not speak one of Canada's two official languages (English or French) |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Alberta Children's Hospital, Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario, Provincial Health Services Authority, The Hospital for Sick Children, University of Calgary, University of Ottawa |
Canada,
Siden HB, Carleton BC, Oberlander TF. Physician variability in treating pain and irritability of unknown origin in children with severe neurological impairment. Pain Res Manag. 2013 Sep-Oct;18(5):243-8. Epub 2013 Jul 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of pain severity of children on the pathway | Number of participants whose pain scores rank in the lower pain categories (category A or B) as compared to the proportion of those on the waitlist group, measured by the parent-reported Pain Survey. | Week 10 | |
Secondary | Identification of causes of pain and irritability of unknown origin in non-verbal children | Number of children with known causes of pain and irritability at end of pathway | End of Pathway (up to 8 months post-baseline) | |
Secondary | Decreased pain & irritability scores for children over time | Pain Survey (baseline score compared to End of Pathway score) | Baseline and End of Pathway (up to 8 months post-baseline) | |
Secondary | Improvement in parent fatigue levels | Parent-reported reduction in fatigue levels on the Patient-Reported Outcomes Measurement Information System (PROMIS-57: Fatigue 8a subscale Max. 40 to Min. 8- higher values worse) from baseline fatigue score compared to End of Pathway score | Baseline and End of Pathway (up to 8 months post-baseline) | |
Secondary | Recorded time commitment for clinical team to implement PIUO Pathway | Average hours of clinical time for MD + RD involved to complete the study per patient | Baseline and End of Pathway (up to 8 months post-baseline) | |
Secondary | Benefit ranking of ongoing communication with study research nurse | Number of parents rating the communication with the nurse as "valuable" as per the Family feedback form. | End of Pathway (up to 8 months post-baseline) |
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