Open Access(228) Randomized Comparison of Medtronic Intrathecal Drug Delivery Systems (IDDS) plus Comprehensive Medical Management (CMM) vs. CMM for Unrelieved Cancer Pain
Author(s) -
Staats Peter,
Smith Tom,
Deer Tim,
Catalrc Elena,
Buchser Eric,
Sterns Lisa,
Bryce David
Publication year - 2001
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/j.1526-4637.2001.pme01039-27.x
Subject(s) - medicine , cancer pain , brief pain inventory , quality of life (healthcare) , randomized controlled trial , opioid , interim analysis , pain medicine , clinical trial , life expectancy , cancer , physical therapy , anesthesia , chronic pain , surgery , population , anesthesiology , receptor , nursing , environmental health
5–15% of cancer patients have unrelieved pain or undesirable side effects despite current best management. IDDS may give better pain control and fewer side effects but there are no randomized clinical trials (RCT). A RCT of IDDS plus CMM vs. CMM alone in patients with unrelieved pain (>5 on 0–10 scale) despite current best management is in progress. The IDDS is the SynchroMed Implantable Drug Delivery System. Outcomes include pain control, quality of life (Brief Pain Inventory, SF‐12, Caregiver Quality of Life Survey), and toxicity (National Cancer Institute Common Toxicity Criteria), Health resource utilization data will assess if avoided pain therapy expenditures balance IDDS cost. The study can detect a 20% difference in pain control and toxicity with a target accrual of 200 patients. Over 100 patients have been accrued at 19 centers in 5 countries. The study arms are balanced with respect to pain intensity (VAS), life expectancy, demographic variables, source of cancer pain, and baseline opioid use vs. unacceptable opioid side effects. An interim analysis will present data on patient baseline characteristics; management course at different centers; and effect of therapy on pain scores, quality of life, toxicity, and resource utilization.