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.