Actively Recruiting
Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)
Led by University of British Columbia · Updated on 2024-05-08
5
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 rationale of this trial is to identify the clinical effect size of gabapentin in reducing and resolving pain in children with developmental brain disorders, specifically those with severe neurological impairment (SNI).
CONDITIONS
Official Title
Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to 18 years with severe neurological impairment (SNI) from any cause
- Children with unexplained pain and irritability who cannot communicate pain location, cause, or type
- Children with cognitive impairment or non-verbal status with severe disability (GMFCS scores 3, 4, or 5 and CFCS level 4 or 5)
- Children scoring more than 3 on two screening scales measuring pain persistence and distress confirming significant pain and irritability
- Evidence of comprehensive evaluation showing no treatable sources of nociceptive-inflammatory pain or irritability
You will not qualify if you...
- Children outside the age range of 6 months to 18 years
- Children able to communicate and localize their pain
- Children diagnosed with pain or irritability cause during enrollment using the PIUO Pathway
- Known allergy or hypersensitivity to study medication
- Participation in another experimental therapy study for pain or irritability
- Poor medical risk due to systemic disease or uncontrolled infection
- Patients scoring A or B on Pain Survey
- Active nociceptive-inflammatory pain at enrollment (e.g., post-operative pain)
- Active renal disease, renal impairment, or low glomerular filtration rate (< 60 mL/min/1.73 m2)
- Significant hepatic impairment as determined by investigator
- Clinically relevant abnormal ECG (if available) as determined by investigator
- Diagnosis of sickle cell disease
- Parents not speaking English or French
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
Research Team
A
Anne-Mette Hermansen, MA
CONTACT
G
Gail Andrews, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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