Gabapentin for treating unexplained pain in children with severe neurological impairment
Efficacy of Gabapentin in Treating Pain in Children With Severe Neurological Impairment
This study is testing if gabapentin can help reduce unexplained pain and irritability in children with severe neurological impairments who can't express their discomfort.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04619862 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of gabapentin in reducing pain and irritability in children with severe neurological impairment who experience unexplained pain, termed Pain and Irritability of Unknown Origin (PIUO). The study focuses on children aged 6 months to 18 years who have cognitive or communication impairments that prevent them from expressing their pain. Participants will be assessed for their pain levels and irritability, and will receive either gabapentin or a placebo in a randomized manner. The goal is to determine if gabapentin can significantly alleviate their symptoms compared to no treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 18 years with severe neurological impairment and unexplained pain or irritability.
Not a fit: Patients who do not have severe neurological impairment or whose pain has a clear identifiable source may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from pain and irritability for children with severe neurological impairments.
How similar studies have performed: While there is limited prospective research on gabapentin for this specific population, previous case series suggest potential benefits, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Vancouver, British Columbia
- BC Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Hal Siden, MD — BC Children's Hospital Research Institute
- Study coordinator: Anne-Mette Hermansen, MA
- Email: ahermansen@bcchr.ca
- Phone: 604 875 2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.