Pain
Conditions
Keywords
Pain, Analgesia, Gabapentin, Amitriptyline, Pediatrics
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.
Interventions
DRUGGabapentin
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.
DRUGAmitriptyline
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in child's pain intensity score | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change in child's pain-related disability ratings | 6 weeks |
Countries
Canada
Outcome results
None listed