Study design: A 3-month follow-up, observational, prospective, multicenter, study in traumatic spinal cord-injured (SCI) patients with neuropathic pain (NP). Objectives: To assess the effectiveness and safety of oxycodone treatment in SCI patients with anticonvulsants-refractory NP. Setting: 'Spinal injury follow-up units' throughout Spain. Methods: Data regarding NP characteristics were collated from male and female adults with traumatic SCI and difficult-to-control central NP of moderate-to-severe intensity (visual analog scale (VAS) X4) persisting X1 month, who had been para-or tetraplegic for X2 months, had been previously treated with anticonvulsants and were now treated with oxycodone. Results: In all, 54 out of the 57 patients recruited were assessable. A total of 81% were men and the mean age was 46.4. Patients were treated with oxycodone, 83% combined with anticonvulsant. Pain intensity (VAS: 7.1 ± 1.3-4.3 ± 1.7) and Lattinen total score (13.2 ± 3-7.7 ± 3.4) decreased significantly (Po0.001) along the study. No patient got worse regarding pain impact on physical activity and on sleep (Lattinen scale). EQ-5D VAS showed a trend to increase (P ¼ 0.061) and the index of preference values increased significantly from baseline to month 3 (0.26-0.62; Po0.001). A total of 53.7% patients showed at least one treatment-related adverse event, with constipation being the most frequent one (33.3%). Conclusion: Oxycodone treatment, mostly in combination with anticonvulsants, in SCI patients with NP decreases pain intensity, improves health-related quality of life and diminishes the impact of pain on physical activity and sleep. Sponsorship: This study has been sponsored by Mundipharma, SL, Madrid, Spain.
BackgroundPatients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs.Methods/DesignThe study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.DiscussionThe aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.Trial registrationNCT01803919
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