Pain and Irritability in Non-Verbal Children (PIUO)
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|ClinicalTrials.gov Identifier: NCT03464773|
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2018
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Neuropathic Pain Irritability||Other: PIUO Pathway||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing the Management of Pain and Irritability of Unknown Origin (PIUO) in Children With Severe Neurological Impairment|
|Actual Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
The PIUO Pathway is implemented by clinicians (MD and RN) with expertise in treating pain in children. Each participant proceeds through the PIUO Pathway as long as their pain persists, but will exit the PIUO Pathway at any stage in case their pain is resolved. The Pathway has two steps: Step 1 is a thorough history and patient evaluation, including directed testing. Step 2 is a series of screening tests to further explore any potential underlying disease or injury not apparent based on history and physical examination.
Other: PIUO Pathway
See arm descriptions
No Intervention: Waitlist
Participants randomized to the Waitlist will cross over to the Pathway after 8 weeks.
- Reduction of pain severity of children on the pathway [ Time Frame: Week 10 ]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.
- Identification of causes of pain and irritability of unknown origin in non-verbal children [ Time Frame: End of Pathway (up to 8 months post-baseline) ]Number of children with known causes of pain and irritability at end of pathway
- Decreased pain & irritability scores for children over time [ Time Frame: Baseline and End of Pathway (up to 8 months post-baseline) ]Pain Survey (baseline score compared to End of Pathway score)
- Improvement in parent fatigue levels [ Time Frame: Baseline and End of Pathway (up to 8 months post-baseline) ]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
- Recorded time commitment for clinical team to implement PIUO Pathway [ Time Frame: Baseline and End of Pathway (up to 8 months post-baseline) ]Average hours of clinical time for MD + RD involved to complete the study per patient
- Benefit ranking of ongoing communication with study research nurse [ Time Frame: End of Pathway (up to 8 months post-baseline) ]Number of parents rating the communication with the nurse as "valuable" as per the Family feedback form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464773
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Hal Siden, MD||BC Children's Hospital Research Institute|