PIUO Pathway for Pain and Irritability

Overseen By Anne-Mette Hermansen, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Age, Communication, Explained pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist children with severe neurological impairments who cannot communicate their pain. It aims to determine if a special method, called the PIUO Pathway, can be used by community pediatricians in British Columbia to identify the causes of unexplained pain and irritability. The goal is to enable doctors to apply this method outside hospitals, improving care for children with complex medical needs. Children with severe neurological issues, who cannot speak and experience unexplained pain, might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for children to potentially benefit from innovative care methods.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PIUO Pathway is safe for children with severe neurological impairments?

Research has shown that the PIUO Pathway is promising for safely managing pain and irritability in children with severe neurological issues. In a small initial study, this Pathway reduced or completely resolved pain and irritability in 63% of the children involved, indicating its effectiveness and safety for many children.

The PIUO Pathway employs a step-by-step method to identify and treat unknown sources of pain. It begins with a detailed history and physical exam and may include tests like urine tests and ultrasounds if needed. Although specific reports of side effects are absent, the focus on thorough assessments suggests a careful approach to safety.

In summary, while specific safety details are not provided, the Pathway's careful and detailed steps imply it is a safe method for addressing pain in children with complex needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PIUO Pathway because it offers a structured and systematic approach to identifying and managing pain in children with severe neurological impairments (SNI). Unlike standard care, which often involves trial and error with pain medications, this pathway uses a two-step process that starts with a detailed pain history and physical examination, followed by targeted screening tests like urinalysis and ultrasound. This methodical progression helps pinpoint pain sources more accurately and quickly, potentially improving outcomes for children and providing much-needed relief for families.

What evidence suggests that the PIUO Pathway is effective for managing pain and irritability in children with severe neurological impairments?

Research has shown that the PIUO Pathway, which participants in this trial will follow, helps identify and manage unexplained pain and irritability in children with severe neurological issues. This Pathway employs a step-by-step method, beginning with a detailed history and physical exam, followed by tests to uncover hidden causes of pain. Studies have found that this approach can enhance medical care by quickly identifying treatable sources of pain. Families and expert doctors report that using this Pathway improves the care experience for children. The main goal is to address pain early to enhance the overall quality of life for these children and their families. ^{1 6 7 8 9}

Who Is on the Research Team?

Hal Siden, MD

Principal Investigator

University of British Columbia and BC Children's Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for children with severe neurological impairments who can't communicate their pain verbally. It's designed to help community pediatricians in British Columbia manage unexplained pain and irritability using the PIUO Pathway, a tool developed for systematic care.

Inclusion Criteria

General pediatricians

Practicing in a community clinic in British Columbia

My child is between 6 months and 18 years old, has special needs, and cannot explain their pain.

Exclusion Criteria

Children that have an explained and treatable cause of pain and irritability. Parents that do not have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools

Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)

My child does not fall within the required age range for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploration

Exploration phase to assess feasibility and factors influencing the implementation of the Pain Pathway

3 months

Installation

Installation phase where community pediatricians are trained to use the Pain Pathway

3 months

Initial Implementation

Initial implementation of the Pain Pathway in community practice settings

6 months

Full Implementation

Full implementation of the Pain Pathway with ongoing evaluation and refinement

6-9 months

Follow-up

Participants are monitored for the effectiveness of the Pain Pathway and family well-being

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PIUO Pathway

Trial Overview The study tests the PIUO Pathway's effectiveness when used by community pediatricians outside of hospital research settings. The goal is to see if this approach can improve clinical care for children with complex medical needs experiencing unknown pain and irritability.

How Is the Trial Designed?

Group I: PIUO Pathway Experimental Treatment 1 Intervention

The PIUO Pathway targets PIUO in an intentional, focused, timely, sequential order of standardized steps to support best outcomes for children with SNI and families. The PIUO Pathway is comprised of 2 steps. Step 1 is for the pediatrician to conduct a thorough history that includes a pain history to identify known and unknown sources of past and current pain, and a physical examination. Step 2 is to carry out a series of screening tests to further explore any potential underlying disease or injury if not apparent based on the Step 1 history and physical examination. The standard screening tests may include urinalysis, ultrasound, gastric pH, and bloodwork. Each child proceeds through the Pain Pathway as long as their pain persists but may not go through all steps if their pain source is identified or pain resolves at any stage. The Steps of the Pain Pathway may be refined by the team based on the results of Phase 1 study analysis, which is underway.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06869928

NCT06869928 | Implementation of the Pain and Irritability ... Effectiveness of the PIUO Pain Pathway will be measured by proportion of children with SNI and families who received appropriate steps of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9531516/

Evaluation of children with severe neurological impairment ... This study was designed to explore the clinical care received by children with SNI admitted to hospital with suspected pain or irritability and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06869928/implementation-of-the-pain-and-irritability-of-unknown-origin-piuo-pathway-in-community-pediatric-practices

Implementation of the Pain and Irritability of Unknown ... The Pain and Irritability of Unknown Origin (PIUO) Pathway is a clinical pathway that was developed to evaluate and manage unexplained pain and irritability ...

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(21)00476-0/fulltext

The Parental Experience of Caring for a Child With Pain ... Parental caregivers described caring for a child with persistent PIUO as physically and emotionally exhausting, and negatively impacting family quality of life.

5. pediatricpalliative.com pediatricpalliative.com/team-member-publications/the-piuo-pathway-a-systematic-approach-to-managing-pain-and-irritability-in-children-with-severe-neurological-impairment/

The PIUO Pathway: A systematic approach to managing pain ... The goal of the PIUO Pathway is to efficiently identify treatable causes of pain and irritability. We are currently testing the efficacy of the PIUO Pathway.

6. paindetectives.org paindetectives.org/

Pain & Irritability in Children with Health Complexity In a small pilot study of the PIUO Pathway we reduced or resolved pain and irritability for 63% of participants. The primary outcome of our study is better ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3805346/

Physician variability in treating pain and irritability of unknown ... Pain and irritability of unknown origin (PIUO) is a challenging problem for nonverbal children with severe neurological impairments.

8. researchgate.net researchgate.net/publication/364162275_Evaluation_of_children_with_severe_neurological_impairment_admitted_to_hospital_with_pain_and_irritability

Evaluation of children with severe neurological impairment ... Findings are compared to the approach suggested in the PIUO pathway, an integrated clinical pathway for identifying and treating underlying causes of pain and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7437208/

102 Optimizing the Management of Pain and Irritability in ... Pain and irritability of unknown origin (PIUO) is reported to effect 73% of children with severe neurological impairments (SNI), and is a source of stress ...