Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain. The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained. Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained.
Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Seoul, South Korea
Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group.
Time frame: Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)
Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group
Post-treatment secondary efficacy assessments will be used to determine the percentage of difference and secondary efficacy assessments included the following. 1. Korean Oswestry Disability Index score, Korean-Short-Form 36, Beck Depression Index score, investigator and patients global assessment.
Time frame: Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)
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