Intrathecal clonidine in the treatment of intractable pain: a phase I/II study.

Objective: Epidural clonidine has been proven effective in relieving intractable cancer pain, especially neuropathic. This phase I/II study was performed to investigate if intrathecal clonidine is well tolerated and effective for long-term treatment of intractable chronic pain.

Design: Thirty-one patients, previously implanted with programmable pumps and unable to obtain adequate pain relief with opioids and adjuvant oral medications, were enrolled. Clonidine monotherapy was initiated at 1 mcg/hr and escalated to a maximum of 40 mcg/hr (960 mcg/day). Efficacy measurements included Verbal Digital Pain Ratings, and side effects were determined by physical exam and patient reports.

Results: Patients achieving 50% or greater reduction in pain intensity scores in the dose-titration phase continued for long-term follow-up. Twenty-two patients (71%) entered long-term follow-up with intrathecal clonidine; nine patients (29%) did not obtain adequate pain control in the dose-titration phase. Thirteen patients were considered long-term successes with a mean follow-up of 16.7 months (range = 6.3 to 44 months). Nine patients failed to achieve adequate pain relief due to side effects or lack of efficacy. Fifty-nine percent of the patients successful in the dose-titration stage (42% of all patients considered) were considered long-term successes. Patients in the long-term phase maintained adequate pain control with minimal dose escalation.

Conclusions: This study demonstrates the tolerability and effectiveness of intrathecal clonidine in the treatment of chronic pain. The physician using clonidine for long-term intrathecal infusion should be cognizant of the risk that severe rebound systemic hypertension can occur with abrupt cessation of the intrathecal infusion of clonidine.