Written by Hal Siden

RESEARCH PROJECT: Optimizing the management of pain and irritability in children with severe neurological impairments

Lead investigators/designated PI’s

Hal Siden

Approval Date

May 23, 2017


Est. end date December, 2023

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. We call this entity Pain and Irritability of Unknown Origin (PIUO). Informed by our clinical and research experience, we 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. 

Our plan is to evaluate the effectiveness of an integrated clinical pathway (i.e. a sequential order of standardized evaluation steps) for managing unexplained pain and irritability in children with complex conditions and limited communication. If the PIUO Pathway proves to be useful in addressing PIUO in children with severe neurological impairments (SNI), the results will create the first-ever systematized practice guideline to treating pain in this population based on a solid evidence base. Such guidelines will streamline pain management for this population and improve the children and their families’ wellbeing. Our hypothesis is children participating in the PIUO Pathway will experience improvement or resolution of PIUO from baseline to post-study, and as compared to children receiving treatment as usual while on our waitlist.

The purpose of this study is to develop, test, and disseminate an approach to reducing and resolving pain in children with developmental brain disorders, specifically those with SNI. It focuses on the problem of ongoing, unexplained, and difficult-to-treat pain and irritability that many children with SNI, and their families experience. 

The goal is to improve the assessment and treatment of pain and irritability in children with complex health conditions and multiple disabilities who have limited communication and cognition. These children are among the most vulnerable seen in any hospital or medical clinic.

In this study, we will use a waitlist-controlled RCT design, with 120 children randomized to PIUO Pathway or waitlist (standard care) treatment arms. The primary outcome is improved pain control for non-verbal children with SNI as shown in a reduction of their pain and irritability scores for the pathway group compared to the control arm for two consecutive weeks starting at week eight or ten. Secondary outcomes include successful identification of common causes of pain and irritability in non-verbal children, decreased pain severity between baseline, and the end of pathway (within 8 months post-baseline), improved family quality of life, and ease of implementation of the PIUO Pathway for clinicians. We will also collect family feedback on the implementation of the PIUO Pathway.