Official Title: “Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • Gabapentin will be prescribed at 900mg/d (300mg tid). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
• Drug: Amitriptyline
  • Amitriptyline will be prescribed at a dose of 10mg (qhs). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• change in child's pain intensity score
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• change in child's pain-related disability ratings
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Hospital for Sick Children

Overall Clinical Trial Officials and Contacts

Patricia McGrath, PhD Principal Investigator The Hospital for Sick Children, Toronto Canada  

Overall Contact: Eric Crawford 416-813-7654 eric.crawford@sickkids.ca

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00312260

Study ID Number: 1000008259

ClinicalTrials.gov Identifier: NCT00312260

Health Authority: Canada: Health Canada