Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

This was a randomized, controlled, open-label, multi-center, prospective post-market study to assess pain control and opioid-related side effects following a route of delivery change to low dose IT morphine therapy from systemic opioid therapy. Subjects with nonmalignant, chronic, intractable pain who were experiencing inadequate pain relief and/or intolerable side effects from systemic opioid therapy receiving ≤300 mg/day morphine equivalent dose were eligible for screening. Additionally, the subjects had no known history of sleep apnea and were candidates for IT morphine administration via the SynchroMed Infusion System. Subjects must not have previously undergone an intrathecal/epidural trial for pump infusion therapy.