Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Johns Hopkins University

Status: Completed

Conditions: Peripheral Neuropathy; Complex Regional Pain Syndromes (CRPS)

Treatments: Drug: Transdermal Fentanyl

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00181246

20021288

Details and patient eligibility

About

The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Neuropathic pain persisting for > 3 months
• Pain over the immediate previous three months
• The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment

Exclusion criteria

• A history of substance abuse
• Allergic reaction to an opioid
• Significant pain of alternate etiology other than the neuropathic pain state
• Severe pulmonary disease
• Recent myocardial infarction (within the preceding three months)
• Pregnancy
• Dementia
• Encephalopathy
• Those with life expectancy of less than six months and HIV seropositivity.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)