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

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Gabapentin (Drug); Amitriptyline (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Patricia McGrath, PhD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: change in child's pain intensity score

Secondary outcome: change in child's pain-related disability ratings

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.

Eligibility

Minimum age: 8 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information

Starting date: April 2006
Last updated: December 13, 2010

Page last updated: August 23, 2015

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