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
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