The Use of Continuous Intrathecal Infusion of Octreotide in Patients with Chronic Pain of Noncancer Origin: An Evaluation of Side-effects and Toxicity in a Prospective Double-blind Fashion.

Introduction.  Intrathecal octreotide has been considered an alternative to opioids in chronic infusion for pain. Octreotide is an analog of the growth hormone sandostatin. Previous work has shown the drug to be efficacious in cancer patients who had failed intrathecal opioids. In this study, we examined the safety of intrathecal octreotide in noncancer pain using continuous intrathecal infusion. Methods.  We examined 20 patients in a double-blind, prospective, randomized fashion comparing safety and adverse effects using saline or octreotide. Data collected include neurologic examination, adverse effect reporting, and cognitive testing. The study was reviewed and approved by the Saint Francis Hospital Institutional Review Board, which also conducted and approved the authorization to use and disclose protected health information for research purposes which describes the privacy law, Health Insurance Portability and Accountability Act (HIPAA). The Saint Francis Hospital IRB and FDA approved the ongoing use of intrathecal octreotide for research. Conclusions.  Intrathecal octreotide, at doses as high as 20 µg/hr, appeared to be as safe as saline when given as a continuous intrathecal infusion. Further work is needed on dose-range analysis and efficacy.