Pain medicine : the official journal of the American Academy of Pain Medicine
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Multicenter Study Clinical Trial
Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
To evaluate the analgesic effectiveness/safety of the new oxycodone 7.5- and 10-mg/acetaminophen 325-mg (Percocet) formulations in patients with low back pain (LBP) suboptimally responsive to nonsteroidal anti-inflammatory drugs, muscle relaxants, tramadol, cyclo-oxygenase-2 inhibitors, and/or prn opioids. ⋯ The primary purpose of this study was to preliminarily test the effectiveness of the new formulations of oxycodone/acetaminophen with reduced acetaminophen in the clinical practice setting. The results from this trial suggest that these formulations are effective in the treatment of moderate-to-severe chronic LBP. Most patients (67%) reported significant pain relief/tolerable side effects with a TID dosing frequency or less (mean: 3.04 doses/day), suggesting chronic pain patients can experience meaningful pain relief with around-the-clock dosing of oxycodone/acetaminophen and minimal risk of hepatotoxicity. Further long-term, controlled studies of the efficacy/safety of the new formulations of oxycodone/acetaminophen in LBP are warranted to fully characterize efficacy in this patient population and corroborate the findings from our study.