The journal of pain : official journal of the American Pain Society
-
Randomized Controlled Trial Clinical Trial
Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain.
The visual analog scale (VAS) is one of the most commonly used measures of pain intensity in pain research. However, there remain important unanswered questions concerning interpretation of specific VAS ratings and change scores. ⋯ As predicted, in assessment of the amount of change corresponding to differing levels of pain relief, percentage change in a patient's VAS score was less biased by pretreatment pain than was absolute change score. The findings also suggested that a 33% decrease in pain represents a reasonable standard for determining that a change in pain is meaningful from the patient's perspective.
-
Clinical practice and quality improvement (QI) guidelines for acute postoperative pain management have been developed to address the well-documented problem of undertreatment of postoperative pain. The Post-Operative Pain Management Quality Improvement Project (the POP Project) was initiated to determine whether an intervention designed to support hospitals in the development of QI efforts would lead to improvements in structures, processes, and outcomes consistent with recommended guidelines. A nationwide sample of 233 hospitals joined the project. ⋯ Patient survey data showed no change in pain outcomes. Evaluation data showed that 70% of hospitals were very or extremely satisfied with their participation in the POP Project and 90% of them planned to continue efforts to improve pain management after the POP Project ended. Further research is needed to determine how to translate the excellent results obtained for structure and process into meaningful outcomes for patients.
-
Randomized Controlled Trial Comparative Study Clinical Trial
The pharmacokinetics of transdermal fentanyl delivered with and without controlled heat.
Preliminary reports have demonstrated that the application of local heat to the transdermal fentanyl patch significantly increased systemic delivery of fentanyl. The objective of this study was to further evaluate the pharmacokinetic effect of local heat administration on fentanyl drug delivery through the transdermal fentanyl patch delivery system in volunteers. In addition, the study was intended to document the effect of heat on steady-state transdermal fentanyl delivery. ⋯ Applying heat for 15 minutes at the 12-hour and 16-hour time points produced a rapid but short duration increase in serum fentanyl concentrations. The results suggest controlled heat might be used to significantly shorten the time needed to reach clinically important fentanyl concentrations. Controlled heat might be useful to produce rapid increases in serum concentrations for the rapid treatment of breakthrough pain.
-
Randomized Controlled Trial Clinical Trial
Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial.
We evaluated etoricoxib, a novel COX-2-specific inhibitor, in 319 patients with chronic low back pain (LBP) in this double-blind, placebo-controlled trial. Patients were randomized to a 60 mg dose (n = 103) or 90 mg dose (n = 107) of etoricoxib, or placebo (n = 109), daily for 12 weeks. The primary endpoint was low back pain intensity scale (Visual Analog Scale of 0- to 100-mm) time-weighted average change from baseline over 4 weeks. ⋯ Etoricoxib provided significant improvement from baseline versus placebo in pain intensity (4 weeks: 12.9 mm and 10.3 mm for 60-mg and 90-mg doses, P <.001 for each; 12 weeks: 10.5 mm and 7.5 mm for 60-mg and 90-mg doses, P =.001 and.018, respectively). Etoricoxib at either dose led to significant improvement in other endpoints, including RMDQ scores, bothersomeness scores and global assessments. Etoricoxib given once daily provided significant relief of symptoms, and disability associated with chronic LBP that was observed 1 week after initiating therapy, was maximal at 4 weeks, and was maintained over 3 months.