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

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Gabapentin; Drug: Amitriptyline

Study type: Interventional

Funder types: Other

Identifiers

NCT00312260

1000008259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Gabapentin

2

Active Comparator group

Treatment:

Drug: Amitriptyline