Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)

Launched by UNIVERSITY OF BRITISH COLUMBIA · Nov 2, 2020

Keywords

ClinConnect Summary

This clinical trial, called the Gabapentin Trial, is studying the effects of a medication called gabapentin in helping reduce pain and irritability in children with severe brain-based developmental disabilities. Many of these children experience ongoing pain that is hard to explain and often cannot communicate their discomfort, which can make it challenging for caregivers to understand what they are going through. The goal of this trial is to see if gabapentin can effectively lessen or eliminate this unexplained pain, known as Pain and Irritability of Unknown Origin (PIUO).

To participate in this trial, children must be aged between 6 months and 18 years and have severe neurological impairments that prevent them from communicating their pain. They should have a score indicating significant pain and irritability based on specific assessments, but there should be no clear treatable source of their discomfort. Families who decide to participate can expect to undergo evaluations to ensure eligibility, and they will be monitored closely throughout the trial. It's important to note that some children may not qualify due to certain health conditions or other ongoing treatments. This research aims to improve the quality of life for children with these challenging symptoms and provide better options for managing their pain.

Gender

ALL

Eligibility 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 as well as Communication Function Classification System (CFCS) level 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".
• • The will be evidence of a comprehensive evaluation of PIUO in the child's medical history, showing no evidence for treatable sources (nociceptive-inflammatory) of pain and/or irritability symptoms.
• Exclusion Criteria:
• • Children not within the specified age range
• • Children with communication capabilities and cognitive development to localize their pain.
• • Participants whose pain and or irritability is diagnosed through completion of the PIUO Pathway during the enrollment phase of the trial.
• • Patients with a known hypersensitivity/allergy to the study medication
• • Patients who are actively participating in another experimental therapy study for pain and/or irritability.
• • Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
• • Patients who score A or B on the Pain Survey
• • Patients who have an active source of nociceptive-inflammatory pain at the time of enrolment (e.g., post-operative pain)
• • Patients with active renal disease, known renal impairment or glomerular filtration rate \< 60 mL/min/1.73 m2 (if known).
• • Patients with known significant hepatic impairment at the discretion of the investigator.
• • Patients with clinically relevant abnormal ECG (if available) at the discretion of the investigator.
• • Patients with diagnosis of sickle cell disease.
• • Parents who do not speak one of Canada's two official languages (English or French)