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Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

Phase 3
Completed
Conditions
Pain
Interventions
Registration Number
NCT00312260
Lead Sponsor
The Hospital for Sick Children
Brief Summary

The objective of the study is to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial.

Detailed Description

Clinical experience and case reports suggest that both amitriptyline and gabapentin are effective treatments for neuropathic pain in children; however we do not know which drug is more effective for specific pain conditions or for specific children. This study will be the first prospective, randomized double-blind controlled trial directly comparing gabapentin and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will also study the time course for pain reduction and evaluate changes in children's physical function, mood, and sleep. This information is needed to determine which drug is better for which children and which pain conditions.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
Inclusion Criteria
  • 8 - 17 years of age
  • Diagnosis of neuropathic pain
Exclusion Criteria
  • Additional health problems
  • Lactose intolerant
  • Unable to swallow size 0 gelatin capsules
  • Pregnant
  • Unable to speak English

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Gabapentin-
2Amitriptyline-
Primary Outcome Measures
NameTimeMethod
change in child's pain intensity score6 weeks
Secondary Outcome Measures
NameTimeMethod
change in child's pain-related disability ratings6 weeks

Trial Locations

Locations (1)

The Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

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