The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
Predictors of long-term opioid use among patients with painful lumbar spine conditions.
Our objective was to assess predictors of self-reported opioid use among patients with back pain due to lumbar disc herniation or spinal stenosis. Data were from the Spine Patient Outcomes Research Trial (SPORT), a multi-site observational study and randomized trial. We examined characteristics shown or hypothesized to be associated with opioid use. Using generalized estimating equations, we modeled associations of each potential predictor with opioid use at 12 and 24 months. At baseline, 42% of participants reported opioid use. Of these participants, 25% reported continued use at 12 months and 21% reported use at 24 months. In adjusted models, smoking (RR = 1.9, P < .001 at 12 months; RR = 1.5, P = .043 at 24 months) and nonsurgical treatment (RR = 1.7, P < .001 at 12 months; RR = 1.8, P = .003 at 24 months) predicted long-term opioid continuation. Among participants not using opioids at baseline, incident use was reported by 8% at 12 months and 7% at 24 months. We found no significant predictors of incident use at 12 or 24 months in the main models. In conclusion, nonsurgical treatment and smoking independently predicted long-term continued opioid use. To our knowledge, this is the first longitudinal study to assess predictors of long-term and incident opioid use among patients with lumbar spine conditions. ⋯ This longitudinal study of patients with disc herniation or spinal stenosis found that nonsurgical treatment and smoking predicted long-term self-reported opioid use. The greater risk of opioid continuation with nonsurgical therapy may be helpful in decision-making about treatment. The relationship between opioid use, smoking, and other substance use deserves further study.
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Multicenter Study Clinical Trial
A multicenter, open-label, exploratory dose-ranging trial of intranasal hydromorphone for managing acute pain from traumatic injury.
We conducted a prospective multicenter, open-label, escalating dose-range trial to compare, across patients, single intranasal doses (2, 4, 6, 8, and 10 mg) of hydromorphone HCl in the treatment of acute trauma pain The main outcome measure of pain-intensity reduction was derived from serial Numerical Pain-Rating Scores and calculated as the summed pain-intensity difference over 3 hours (SPID 3). Nasal examinations, vital signs, and adverse events were reported as safety outcomes. The mean decrease in pain intensity from baseline to 30 minutes was 39 to 44% for the 4-, 6-, 8- and 10-mg doses (n = 19, 33, 28, and 19 per group) and only 24% reduction for the 2-mg dose (n = 14). SPID 3 for the 2-mg dose was 40 to 50% below all other doses. There were no clinically meaningful changes in vital signs or nasal examinations. Adverse events (nausea, vomiting, pruritus, oxygen desaturation, bad taste, dizziness) were of mild to moderate intensity, increased with dose, and expected, based on route of administration and opioid pharmacology. Intranasal hydromorphone provides a component of rapid pain relief in the care of emergency department patients suffering from acute trauma pain. ⋯ This article presents a pilot dose-ranging study of intranasally administered hydromorphone, administered in the emergency department to patients suffering from acute trauma pain. This study demonstrates research success in this setting and noninjection-based delivery and certain doses of intranasal hydromorphone may be effective in treating acute trauma pain.