NCT03464773: PIUO

Pain and Irritability in Non-Verbal Children

Completed NA Last updated 8 May 2024

What this trial tests

NA trial testing PIUO Pathway in Pain in 72 participants. Completed in 31 July 2023.

Timeline

15 April 2018

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	72
Start date	15 April 2018
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across Canada

Drugs / interventions tested

• PIUO Pathway

Conditions studied

• Pain — all drugs for Pain →
• Neuropathic Pain — all drugs for Neuropathic Pain →
• Irritability — all drugs for Irritability →

Sponsor

University of British Columbia

Who can join

Adults 6 Months to 18, any sex, with Pain or Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Abstracts from the 4th Annual Student Medical Summit : Virtual. 6 February 2021.
   · 2021 · PMID 33975599 · DOI 10.1186/s12919-021-00213-8