Pain and Irritability in Non-Verbal Children

NCT03464773 | Completed DMC

• 1 other identifier: H16-03288
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Neuropathic Pain; Irritability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Identification of causes of pain and irritability of unknown origin in non-verbal children

  End of Pathway (up to 8 months post-baseline)

• Decreased pain & irritability scores for children over time

  Baseline and End of Pathway (up to 8 months post-baseline)

• Improvement in parent fatigue levels

  Baseline and End of Pathway (up to 8 months post-baseline)

• Recorded time commitment for clinical team to implement PIUO Pathway

  Baseline and End of Pathway (up to 8 months post-baseline)

• Benefit ranking of ongoing communication with study research nurse

  End of Pathway (up to 8 months post-baseline)

Study Arms (2)

Pathway

OTHER

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

Waitlist

NO INTERVENTION

Participants randomized to the Waitlist will cross over to the Pathway after 8 weeks.

Interventions

PIUO Pathway OTHER

See arm descriptions

Pathway

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Calgary: collaborator
• University of Ottawa: collaborator
• Provincial Health Services Authority British Columbia: collaborator
• Alberta Children's Hospital: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

• 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. doi: 10.1155/2013/193937. Epub 2013 Jul 24.

  PMID: 23885348 BACKGROUND

Related Links

• Study website

MeSH Terms

Conditions

Pain; Neuralgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Hal Siden, MD

  BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: March 14, 2018
• Study Start: April 15, 2018
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)