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Trial record 11 of 84 for:    Developmental Disabilities | ( Map: Canada )

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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Calgary
University of Ottawa
Provincial Health Services Authority
Alberta Children's Hospital
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
Information provided by (Responsible Party):
Harold Siden, University of British Columbia

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 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.

Condition or disease Intervention/treatment Phase
Pain Neuropathic Pain Irritability Other: PIUO Pathway Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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

Arm Intervention/treatment
Pathway
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
University of Calgary
University of Ottawa
Provincial Health Services Authority
Alberta Children's Hospital
Children's Hospital of Eastern Ontario
The Hospital for Sick Children
Investigators
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Principal Investigator: Hal Siden, MD BC Children's Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by Harold Siden, University of British Columbia:
Study Protocol  [PDF] April 8, 2019


Additional Information:
Publications:
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Responsible Party: Harold Siden, Dr., University of British Columbia
ClinicalTrials.gov Identifier: NCT03464773     History of Changes
Other Study ID Numbers: H16-03288
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms