drugset / Trial / NCT04619862
Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)
Phase 2
Unknown
5 enrolled
University of British Columbia
BC Children's Hospital Research Institute · collabCanadian Institutes of Health Research (CIHR) · collabChild-Bright Network · collab
RandomizedCrossoverTriple-blindTreatment
Summary
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).
Timeline
- Start
- 2021-05-15
- Primary completion
- 2026-03-31
- Completion
- 2026-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 45 mg/kg | Oral |
| Subject | Gabapentin | Small molecule | 60 mg/kg | Oral |