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Background and Objectives: The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR). Methods: In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 μg fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings (“excellent” or “good”) on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed. Results: The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: −4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: −0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups. Conclusions: Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.

Little is known about the long-term effects of analgesics on functional status and well-being of nursing home residents with chronic pain.Using the Minimum Data Set, we performed a longitudinal study of nursing home residents (n = 10,372) with persistent pain. Using propensity score adjustment techniques, we compared the effect of different analgesics on changes in physical, cognitive, emotional, and social functioning, and examined rates of adverse events over a 6-month period.There was no change in the analgesic class for at least 6 months for 35.4% of residents, including 40% who received no analgesics during this time. Use of nonopioids was 37.9%, short-acting opioids was 18.9%, and long-acting opioids was 3.3%. We found improvement in functional status (adjusted hazard ratio = 1.85; 95% confidence interval [CI], 1.05-3.23) and social engagement (adjusted hazard ratio = 1.58; 95%, CI, 0.99-2.50) with long-acting opioids compared with short-acting opioids. There were no changes in cognitive status or mood status, or increased risk of depression with use of any analgesics, including opioids. There was a trend toward a lower risk of falls with use of any analgesics (adjusted odds ratio = 0.87; 95% CI, 0.70-1.06). Rates of other adverse events (i.e., constipation, delirium, dehydration, pneumonia) were not found to be higher among chronic opioid users compared to those taking no analgesics or nonopioids.The use of long-acting opioids may be a relatively safe option in the management of persistent nonmalignant pain in the nursing home population, yielding benefits in functional status and social engagement.

BACKGROUND: Although use of long-acting opioid analgesics has increased for chronic nonmalignant pain management, little is known about patient-reported utilization patterns. OBJECTIVE: To assess patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride (HCl) controlled-release among patients with chronic nonmalignant pain and to compare these patterns to standard dose administration guidelines recommended in the manufacturers’ prescribing information (PI). METHODS: Cross-sectional, observational, multicenter study of English-speaking patients who were seeking chronic nonmalignant pain management from 6 outpatient pain clinics. The inclusion criteria for the study were (1) diagnosis of chronic nonmalignant pain, (2) prescription for and current use of either transdermal fentanyl or oxycodone HCl controlled-release, and (3) duration of use for either transdermal fentanyl or oxycodone HCl controlled-release of at least 6 weeks. Patients completed either an oxycodone HCl controlled-release or transdermal fentanyl utilization questionnaire. A conversion table was used to standardize opioid analgesic doses from transdermal fentanyl or oxycodone HCl controlled-release to daily oral morphine equivalents. The principal outcome measures were the average interval between oxycodone HCl controlled-release administrations, the number of days the current transdermal fentanyl patch would be worn, and the percentage of oxycodone HCl controlled-release and transdermal fentanyl patients whose administration frequency exceeded the standard recommendation in the manufacturer’s PI (every 12 hours for oxycodone HCl controlled-release or every 72 hours for transdermal fentanyl). Other outcome measures included the number of oxycodone HCl controlled-release tablets per administration, the daily dose of long-acting opioid, the duration of adequate pain relief, and the difference in daily oral morphine equivalents between transdermal fentanyl and oxycodone HCl controlled-release patients, after adjusting in a multivariate regression model for demographic and clinical characteristics. RESULTS: A total of 690 patients were enrolled in this study; 437 (63.4%) received oxycodone HCl controlled-release and 253 (36.6%) received transdermal fentanyl. Oxycodone HCl controlled-release patients reported taking a median of 1 tablet 3 times per day or a median of 3 tablets per day. A mean of 1.6 tablets per administration and 4.6 tablets per day were taken. The average interval between administrations of oxycodone HCl controlled-release was 7.8 hours, and the median daily dose was 80.0 mg (mean 155.6 mg). Among oxycodone HCl controlled-release patients, 17.5% had an average interval between administrations of 12 or more hours, whereas 1.9% reported the duration of pain relief as 12 or more hours. Transdermal fentanyl patients reported wearing the patch, on average, for 2.5 days (median 2.5), and 41.2% reported wearing the patch for at least 3 days, whereas 14.1% reported the duration of pain relief as at least 3 days. The median daily dosage strength of transdermal fentanyl was 75.0 mcg/hour. In the multivariate regression analysis, oxycodone HCl controlled-release patients had, on average, roughly 22 mg additional oral morphine equivalents per day relative to transdermal fentanyl patients (not statistically significant); the probability that oxycodone HCl controlled-release patients had higher oral morphine equivalents was 82.6%, which suggests a trend toward higher oral morphine equivalents per day in the oxycodone HCl controlled-release group. CONCLUSION: Transdermal fentanyl and oxycodone HCl controlled-release both appear to be used by patients in a manner that is inconsistent with the standard recommendation in the manufacturers' PI; however, the difference between patient-reported utilization and the PI recommendation is more pronounced with oxycodone HCl controlled-release.

To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities.Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire. Cognitive debriefing interviews were conducted with patients to determine the clarity and content of the instructions, items, and response scales, and the ease of completing the instrument. Psychometric evaluation was performed with patients who had undergone surgery and received IV PCA for postoperative pain management. Item and scale quality and the internal consistency reliability of the questionnaire were assessed. Construct validity was evaluated by examining the relationship between subscales of the questionnaire with patient-reported outcome measures. Known-groups validity was determined by assessing the instrument's ability to differentiate between patients with versus without an IV PCA problem. A potential limitation of this study was the exclusive sampling of patients who had experience with IV PCA.The Patient Ease-of-Care (EOC) Questionnaire included 23 items in the following subscales: Confidence with Device, Comfort with Device, Movement, Dosing Confidence, Pain Control, Knowledge/Understanding, and Satisfaction. Coefficient alpha reliability estimates were ≥ 0.66 for Overall EOC (includes all subscales except Satisfaction) and all EOC subscales. Construct validity was supported by the moderate relationship between the Pain Control subscale and measures of pain severity and pain interference; additional evidence of construct validity was provided by correlations of the Confidence with Device subscale, the Satisfaction subscale, and Overall EOC with measures of pain severity, pain interference, and satisfaction. Significant mean score differences were reported between participants with and without IV PCA problems for Overall EOC and for the Comfort with Device, Confidence with Device, Movement, Pain Control, and Satisfaction subscales indicating known-groups validity.Results provide evidence for the reliability and validity of the Patient EOC Questionnaire as a measure of the ease of use that patients associate with PCA systems and may be useful for evaluating emerging PCA modalities.

Inc., Raritan, New Jersey; ¶ Biostatistics, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA ABSTRACT Objective. The fentanyl HCl iontophoretic transdermal system (ITS) has effectively managed pain following several types of surgery. This study evaluated the efficacy, safety, and ease of care associated with fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) for pain management following abdominal or pelvic surgery. Design. This open-label, multicenter, randomized, active-controlled, parallel-group, phase IIIb study enrolled 506 postoperative patients at 39 U.S. sites. Patients received fentanyl ITS (40 µ g fentanyl/dose) or morphine IV PCA (1 mg morphine/dose). The primary efficacy measure was demonstrating equivalence on the patient global assessment (PGA) of the method of pain control in the first 24 hours of treatment between the groups. Results. Percentages of patients in the fentanyl ITS and morphine IV PCA groups reporting PGA ratings of "good" or "excellent" in the first 24 hours were statistically equivalent (84.9% vs 84.3%, respectively; difference = 0.7%, 95% CI: − 5.6% to 7.0%). Equivalence was also demonstrated based on mean last pain intensity scores in the first 24 hours (3.0 vs 2.9, respectively; difference = 0.1, 95% CI: − 0.28 to 0.43). Overall discontinuation rates were not significantly different between groups (16.7% vs 11.8%, respectively; P = 0.128). Patients and nurses reported better ease-of-care ratings for fentanyl ITS than for morphine IV PCA. Commonly occurring adverse events were similar between groups. Conclusions. Fentanyl ITS and morphine IV PCA were comparable methods of pain control fol- lowing abdominal or pelvic surgery; however, fentanyl ITS was rated better than morphine IV PCA for ease of care by patients and nurses.

The purpose of this study was to evaluate hospital resource utilization associated with intravenous patient-controlled analgesia (IV-PCA), with a focus on nursing, pharmacy, and central supply/engineering time spent from a hospital perspective. Data were collected during a multicenter (29 sites), prospective observational study in the United States of subjects who underwent total knee replacement (TKR), total hip replacement (THR), or abdominal hysterectomy (AH) and were administered analgesia through IV PCA for the management of acute postoperative pain. Nursing staff recorded the IV PCA-related tasks they performed for a subject and the duration of time required to perform each task from initial IV PCA set-up to discontinuation. Hospital administrators, nursing managers, central supply/engineering staff, and pharmacy directors were interviewed to obtain data regarding other IV PCA labor resource use. The distribution of surgery type among the 457 subjects was 31.1% THR, 35.9% TKR, and 33.0% AH. The average duration of IV PCA use was 32.6 hours. Nurses reported having to perform an average of 39.6 IV PCA–related tasks, which required an average of 67.4 minutes. The most common IV PCA–related tasks were evaluating pump use and settings, assessing the IV site, evaluating and addressing analgesia side effects, instructing/reinstructing the subject on use, administering supplemental pain medications, assisting with self-care or moving the subject, and assisting the subject with use of the button. Pharmacists reported that they spend approximately 7.9 minutes and pharmacy technicians spend approximately 9.8 minutes, per subject daily course of IV PCA therapy, on the following tasks: checking and verifying the order, doing inventory of the analgesia, preparing the analgesia (ie, filling reservoirs), checking the analgesia, and delivering the analgesia to the nursing units. In addition, pharmacists and RNs spend an average of 47.3 and 40.7 minutes per year in IV PCA–related training. Intravenous patient-controlled analgesia postoperative care requires coordination and involvement of numerous hospital departments. It is labor intensive and involves numerous time-consuming tasks, oversight of IV PCA, and ongoing training. Alternative methods of patient-controlled pain management with similar efficacy that reduces labor resource utilization may be warranted.

To determine the prevalence of analgesics used, their prescribing patterns, and associations with particular diagnoses and medications in patients with persistent pain.Cross-sectional study.Nursing homes from 10 U.S. states.A total of 21,380 nursing home residents aged 65 and older with persistent pain.Minimum Data Set (MDS) assessments on pain, analgesics, cognitive, functional, and emotional status were summarized. Logistic regression models identified diagnoses associated with different analgesic classes.Persistent pain as determined using the MDS was identified in 49% of residents with an average age of 83; 83% were female. Persistent pain was prevalent in patients with a history of fractures (62.9%) or surgery (63.6%) in the past 6 months. One-quarter received no analgesics. The most common analgesics were acetaminophen (37.2%), propoxyphene (18.2%), hydrocodone (6.8%), and tramadol (5.4%). Only 46.9% of all analgesics were given as standing doses. Acetaminophen was usually prescribed as needed (65.6%), at doses less than 1,300 mg per day. Nonsteroidal antiinflammatory drugs (NSAIDs) were prescribed as a standing dose more than 70% of the time, and one-third of NSAIDs were prescribed at high doses.In nursing home residents, persistent pain is highly prevalent, there is suboptimal compliance with geriatric prescribing recommendations, and acute pain may be an important contributing source of persistent pain. More effective provider education and research is needed to determine whether treatment of acute pain could prevent persistent pain.