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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312260
• Other study ID #: 1000008259
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: March 2, 2017

Study information

• Verified date: October 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2, 2017
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in child's pain intensity score		6 weeks
Secondary	change in child's pain-related disability ratings		6 weeks