Abstract
The present study evaluated the safety and efficacy of patient-activated delivery of intrathecal morphine sulfate boluses delivered by way of a novel internalized intrathecal delivery system. Patients with refractory cancer pain or uncontrollable side effects were enrolled at 17 U5 and international sites in this prospective, open-label study. Pain relief, reduction in systemic opioid use, and reduction in opioid-related complications were analyzed both individually and together as a measure of overall success. One hundred forty-nine patients were enrolled and 119 were implanted. Average numeric analog scale pain decreased from 6.1 to 4.2 at 1 month and was maintained through month 7 (P < .01) and through month 13 (P < .05). Systemic opioid use was significantly decreased throughout the study (P < .01). Significant reduction in the opioid complication severity index was demonstrated at all 4 follow-up visits (P < .01). Overall success (≥50% reduction in numeric analog scale pain, use of systemic opioids, or opioid complication severity index) was reported in 83%, 90%, 85%, and 91% of patients at months 1, 2, 3, and 4, respectively. This study demonstrated that patients with refractory cancer pain or intolerable side effects achieved better analgesia when managed with patient-activated intrathecal delivery of morphine sulfate via an implanted delivery system.
Original language | English (US) |
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Pages (from-to) | 441-447 |
Number of pages | 7 |
Journal | Journal of Pain |
Volume | 4 |
Issue number | 8 |
DOIs | |
State | Published - Oct 2003 |
Keywords
- Cancer pain
- Intrathecal
- Opioid
- Patient-activated
ASJC Scopus subject areas
- Neurology
- Clinical Neurology
- Anesthesiology and Pain Medicine