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

NCT ID: NCT00312260

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2017-03-02

Brief 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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

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.

2

Group Type: ACTIVE_COMPARATOR

Amitriptyline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stephen Brown

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Brown, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000008259

Identifier Type: -

Identifier Source: org_study_id