Written by Hal Siden
research project: efficacy of gabapentin in treating pain in children with sever neurological impairment
Lead investigators/designated PI’s
November 23, 2020
Children with severe neurological impairment can experience a type of pain that does not conform to the standard definition. Because of their impairment, these children are unable to describe the site of their pain. Our team has named this sensation Pain and Irritability of Unknown Origin (PIUO). As a result of this, standard pain treatments have been unsuccessful in alleviating PIUO. Gabapentin, an anticonvulsant drug, has been used since the 1990s as a reliever of chronic, complex pain, and has shown to be safe for use in children. Although gabapentin has been used as an analgesic for over 20 years, there is a lack of prospective research investigating the properties and actions of this treatment.
We hope that our study will elucidate details about the drug, including its efficacy in treating PIUO, optimal dosage, latency period, tolerability, and safety. Our hypothesis is that treatment with gabapentin will lead to a more improved Non Communicating Children’s Pain Checklist – Revised (NCCPC-R) score than treatment with placebo. Our research will be repeated measures single cross-over trials (treatment and placebo).
The purpose of this study is to determine the efficacy of gabapentin as a reliever of pain and irritability of unknown origin (PIUO) in children with severe neurological impairment.
- To evaluate the effectiveness of gabapentin to decrease pain and irritability in children with SNI, when the source of pain and irritability is attributed to neurological dysregulation, and not to a nociceptive-inflammatory cause.
- Identify the optimal dosing of gabapentin in reducing pain and irritability
- Identify the latency time for gabapentin to show effectiveness
- Evaluate the safety and tolerability of gabapentin
- To evaluate whether parent/caregiver stress and function improve if gabapentin reduces child’s pain and irritability
Methods and Procedures:
Standard Treatment: Dosing will begin at 5mg/kg/day of gabapentin. The dose will be escalated over the course of 19 days. The maximum dose will be 60 mg/kg/day in participants < 15 kg or 45 mg/kg/day (675 mg) in participants > 15 kg.
Placebo: This study will include a placebo treatment. This is required to provide a baseline to which the effects of gabapentin can be compared. Each phase is 28 days.