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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00312260

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

131

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Gabapentin Drug: Amitriptyline	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Mar 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.
Active Comparator: 2	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.

Arm

Intervention/Treatment

Experimental: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

change in child's pain intensity score [6 weeks]

Secondary Outcome Measures

change in child's pain-related disability ratings [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

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

Investigators

Principal Investigator: Stephen Brown, MD, The Hospital for Sick Children, Toronto Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Brown, Staff Anesthesiologist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT00312260

Other Study ID Numbers:

1000008259

First Posted:

Apr 7, 2006

Last Update Posted:

Oct 20, 2020

Last Verified:

Oct 1, 2020

Keywords provided by Stephen Brown, Staff Anesthesiologist, The Hospital for Sick Children

Additional relevant MeSH terms:

Neuralgia

Gabapentin

Amitriptyline

Study Results

No Results Posted as of Oct 20, 2020