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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Amitriptyline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Gabapentin<br>* 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.<br>|
| Active Comparator: 2<br> | Drug: Amitriptyline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in child's pain intensity score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in child's pain-related disability ratings |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Analgesia, Gabapentin, Amitriptyline, Pediatrics