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Outcomes research studies use clinical and administrative data generated in the course of patient care or from patient surveys to examine the effectiveness of treatments. Health care providers need to understand the limitations and strengths of the real-world data sources used in outcomes studies to meaningfully use the results. This paper describes five types of databases commonly used in the United States for outcomes research studies, discusses their strengths and limitations, and provides examples of each within the context of pain treatment. The databases specifically discussed are generated from (1) electronic medical records, which are created from patient-provider interactions; (2) administrative claims, which are generated from providers' and patients' transactions with payers; (3) integrated health systems, which are generated by systems that provide both clinical care and insurance benefits and typically represent a combination of electronic medical record and claims data; (4) national surveys, which provide patient-reported responses about their health and behaviors; and (5) patient registries, which are developed to track patients with a given disease or exposure over time for specified purposes, such as population management, safety monitoring, or research. [ABSTRACT FROM AUTHOR]

Opioids are commonly used to treat moderate to severe pain. Opioid-induced hyperalgesia is a paradoxical response to opioid agonists resulting in an increased perception of pain rather than an antinociceptive effect. Even though there is a debate regarding its clinical relevance, it is becoming a challenge in both acute and chronic pain settings. The study of opioid-induced hyperalgesia is an emerging field with multiple challenges faced by investigators with regard to defining the diagnosis and characterizing the findings. The objective of this study was to review the preliminary evidence related to the treatment and management of opioid-induced hyperalgesia. Lack of data, small patient numbers, short-term follow-up, and variations in study design limited the review. With the literature on this subject being sparse, this study attempts to provide a preliminary look at the available data and to set the stage for an eventual meta-analysis. Case reports in the literature have shown success with various pharmacological interventions. Possible treatment regimens include ketamine, dextromethorphan, and nonsteroidal anti-inflammatory drugs (NSAIDs), opioid switching, amantadine, buprenorphine, α2 agonists, and methadone. These agents are briefly discussed in this paper. Further well-designed, placebo-controlled trials are needed to assess the effectiveness of the interventions investigated in this review. [ABSTRACT FROM AUTHOR]

Osteoarthritis (OA) is the most common debilitating joint disease worldwide. Clinicians have many therapeutic modalities and prescription medications in their arsenals to treat chronic inflammatory pain. However, as patients age, and develop numerous comorbidities, the most common, and often most effective pharmacologic treatment for OA, nonsteroidal anti-inflammatory drugs (NSAIDs), becomes problematic in that it may exacerbate or even cause cardiovascular, renal, and/or gastrointestinal pathology. This paper reviews the metabolism of arachidonic acid as it relates to the clinical treatment of inflammation, and explores a novel botanical therapy, flavocoxid, that has shown equal efficacy to naproxen in treating pain associated with mild to moderate OA of the knee. Flavocoxid has demonstrated balanced inhibition of the three primary enzymes responsible for processing AA, cyclooxygenases 1 and 2, and 5-lipoxygenase. Researchers have proposed that balanced inhibition of AA metabolism offers the promise of analgesia similar to NSAIDs without the associated cardiovascular, renal, or gastrointestinal side effects. [ABSTRACT FROM AUTHOR]

The Cochrane Library of Systematic Reviews is published quarterly as a DVD and monthly online (). The April 2014 issue (2nd DVD for 2014) contains 5945 complete reviews, 2353 protocols for reviews in production, and 30,000 short summaries of systematic reviews published in the general medical literature. In addition, there are citations of 778,000 randomized controlled trials and 15,700 cited papers in the Cochrane Methodology Register. The Health Technology Assessment database contains some 13,000 citations. Ninety-eight new reviews have been published in the previous 3 months, of which just two have potential relevance for practitioners in pain and palliative medicine. The impact factor of the Cochrane Library stands at 5.715. Readers are encouraged to access the full report for any articles of interest as only a brief commentary is provided. [ABSTRACT FROM AUTHOR]

The Cochrane Library of Systematic Reviews is published quarterly as a DVD and monthly online. The January 2012 issue (1st DVD for 2012) contains 4929 complete reviews, 2098 protocols for reviews in production, and 16773 short summaries of systematic reviews published in the general medical literature. In addition, there are citations of 666,000 randomized controlled trials, and 15,000 cited papers in the Cochrane methodology register. The health technology assessment database contains just over 11,000 citations. One hundred and thirty-six new reviews have been published in the last 3 months, of which nine have potential relevance for practitioners in pain and palliative medicine. The impact factor of the Cochrane Library stands at 6.186. Readers are encouraged to access the full report for any articles of interest as only a brief commentary is provided. [ABSTRACT FROM AUTHOR]

Cough associated with cancer or nonmalignant chronic disease is common and distressing. Levodropropizine, a peripherally acting drug, has been used as an alternative antitussive to opioids. The authors aimed to determine the efficacy and safety of levodropropizine in relieving cough associated with cancer or nonmalignant chronic disease. The authors searched five databases and hand searched relevant journals to identify randomized and nonrandomized controlled trials assessing the antitussive effect of levodropropizine for cough associated with cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease, or chronic heart failure. Study quality was assessed using a modified version of the Centre for Reviews and Dissemination criteria. The search yielded 58 references. Six were checked in more detail, and four studies were included. Two were randomized controlled trials (RCTs) testing levodropropizine against dihydrocodeine and moguisteine, and two were nonrandomized placebo-controlled studies, all with important limitations and high risk of bias. Levodropropizine was significantly more effective than placebo in reducing cough frequency and severity, and equally effective as dihydrocodeine or moguisteine. It was generally well tolerated. The authors conclude that the evidence for the antitussive efficacy of levodropropizine in these patients is scarce, and is further limited by the methodological weaknesses of the primary studies. Further well-designed research is needed to support its use. [ABSTRACT FROM AUTHOR]

Introduces a segment in the 'Journal of Pain and Palliative Care Pharmacotherapy' which will address outcomes research and pharmacoeconomics in pain and palliative care. Goal of the segment; Common types of outcomes research that are relevant to pain and symptom control; Discussion on the factors involved in pharmacokinetics.

Questions from patients about medical marijuana use for chronic pain are becoming more common. The information in this report will help patients understand the potential risks and benefits of using this substance for painful conditions. [ABSTRACT FROM AUTHOR]

Recently published feline data suggest that high doses of buprenorphine can elevate creatinine kinase (CK) and profoundly influence triglyceride levels in an inverted dose versus effect relationship. This intriguing observation in felines, hitherto not documented for buprenorphine, should be considered in human situations for any trends of translatability. The report evaluates the observed effects in domestic cats and what is known about buprenorphine in human subjects. Based on the objective assessment, the following are deduced: (a) although elevated CK levels is a nonissue in humans, one needs to pay attention especially when buprenorphine is used at the high end of therapeutic dose range in the presence of drugs that can impair the hepatic metabolism of buprenorphine; and (b) the potential for triglyceride lowering can be easily confirmed in human trials, and since it may occur at the relevant therapeutic doses of buprenorphine, it may be beneficial in such patients who may have added cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Chronic neuropathic pain is often refractory to standard pharmacological treatments. Although growing evidence supports the use of inhaled cannabis for neuropathic pain, the lack of standard inhaled dosing plays a major obstacle in cannabis becoming a 'main stream' pharmacological treatment for neuropathic pain. The objective of this study was to explore the pharmacokinetics, safety, tolerability, efficacy, and ease of use of a novel portable thermal-metered-dose inhaler (tMDI) for cannabis in a cohort of eight patients suffering from chronic neuropathic pain and on a stable analgesic regimen including medicinal cannabis. In a single-dose, open-label study, patients inhaled a single 15.1 ± 0.1 mg dose of cannabis using the Syqe Inhaler device. Blood samples for Δ9-tetrahydrocannabinol (THC) and 11-hydroxy-Δ9-THC were taken at baseline and up to 120 minutes. Pain intensity (0-10 VAS), adverse events, and satisfaction score were monitored following the inhalation. A uniform pharmacokinetic profile was exhibited across all participants (Δ9-THC plasma Cmax ± SD was 38 ± 10 ng/mL, Tmax ± SD was 3 ± 1 minutes, AUC0→infinity ± SD was 607 ± 200 ng·min/mL). Higher plasma Cmax increase per mg Δ9-THC administered (12.3 ng/mL/mg THC) and lower interindividual variability of Cmax (25.3%), compared with reported alternative modes of THC delivery, were measured. A significant 45% reduction in pain intensity was noted 20 minutes post inhalation ( P = .001), turning back to baseline within 90 minutes. Tolerable, lightheadedness, lasting 15-30 minutes and requiring no intervention, was the only reported adverse event. This trial suggests the potential use of the Syqe Inhaler device as a smokeless delivery system of medicinal cannabis, producing a Δ9-THC pharmacokinetic profile with low interindividual variation of Cmax, achieving pharmaceutical standards for inhaled drugs. [ABSTRACT FROM AUTHOR]

The proven therapeutic efficacy of methadone in cancer pain is hindered by a challenging pharmacokinetic-pharmacodynamic profile, considerable interpatient variation, and increasing concern about the complexities of dosing. The objective of this study was to assess the evidence for the use of methadone in cancer pain management. The authors conducted a systematic literature search for randomized controlled trials (RCTs) published post the 2007 Cochrane review of methadone in cancer pain. Trial quality was assessed using the Oxford Quality Scoring System and Cochrane Handbook for Systematic Reviews of Interventions. Of the 152 abstracts found, 4 were RCTs (272 participants). Two RCTs compared the efficacy and safety of methadone with placebo or active control and two investigated rotation to methadone from other opioids. The studies used different routes of administration, dosing, initiation, and titration of methadone and distinct pain scoring tools and did not address the issues raised by the Cochrane review. Methadone has an important role in the management of cancer pain, with many advantages including low cost, high oral bioavailability, rapid onset of action, once-daily dosing, and postulated benefits in difficult pain control scenarios. However, due to limited research in this area, methadone dosing remains a challenge, with vigilant dose initiation, adjustment, and monitoring required. There is a need for further studies using standardized methodology to evaluate the optimal dosing strategy of methadone, the effect on different types of pain, and the role of pharmacokinetics and pharmacogenomics in clinical outcomes. [ABSTRACT FROM AUTHOR]

Adenocarcinoma of the gallbladder and cholangiocarcinoma account for 4% and 3%, respectively, of all gastrointestinal cancers. Advanced biliary tract carcinoma has a very poor prognosis with all current available modalities of treatment. In this pilot open-label study, the authors investigated the efficacy and safety of a combination of dimethyl sulfoxide-sodium bicarbonate (DMSO-SB) infusion and S-adenosyl-L-methionine (ademetionine) oral supplementation as palliative pharmacotherapy in nine patients with advanced nonresectable biliary tract carcinomas (ABTCs). Patients with evidence of biliary obstruction with a total serum bilirubin ≤300 μmol/L were allowed to join the study. The results of this 6-month study and follow-up of all nine patients with ABTC indicated that the investigated combination treatment improved pain control, blood biochemical parameters, and quality of life for the patients. Moreover, this method of treatment has led to a 6-month progression-free survival for all investigated patients. The treatment was well tolerated for all patients without major adverse reactions. Given that ABTC is a highly fatal malignancy with poor response to chemotherapy and targeted drugs, the authors consider that the combination of DMSO-SB and ademetionine deserves further research and application as a palliative care and survival-enhancing treatment for this group of patients. [ABSTRACT FROM AUTHOR]

A 36-year-old female with metastatic breast cancer involving bones, liver, lung, and pleura/chest wall with worsening back pain received weight-based intravenous (IV) ketamine and was transitioned to oral ketamine for cancer-related neuropathic pain. She had responded poorly to outpatient pain regimen of oxycodone sustained and immediate release, hydromorphone, gabapentin, and duloxetine (approximate 480 mg total oral morphine equivalents [OME]), reporting an initial pain score of 10/10. She was started on hydromorphone parenteral patient-controlled analgesia (PCA) bolus dose in addition to her outpatient regimen. Despite escalating doses of opioids and the addition of a lidocaine 5% patch, the patient's pain remained uncontrolled 6 days after admission. On hospital day 7, utilizing a hospital weight-based ketamine protocol, the patient was started on subanesthetic doses of ketamine at 0.2 mg/kg/h (288 mg/24 h) and titrated over 2 days to 0.4 mg/kg/h (576 mg/24 h). Then, a 3-day rotation from intravenous to oral ketamine was initiated, and the patient was discharged on ketamine oral solution, 75 mg every 8 hours. When the patient's dose was increased to 0.4 mg/kg/h, adequate pain relief was charted by the nurse within 120 minutes, 'patient pain free and resting comfortably.' Her pain continued to be well managed, with an average pain score of 5/10 with the ketamine continuous infusion and sustained with conversion to oral ketamine without any report of side effects. This was a 37% reduction in pain scores. With the patient's stabilized dose of ketamine, opioid requirements decreased by 61.4% (1017.5 mg reduction in total OME). The use of weight-based dosing of IV continuous infusion and transition to oral ketamine was effective and tolerable in the management of opioid-refractory, neuropathic cancer pain. It is hoped that this case report promotes a discussion regarding ketamine dosing in refractory neuropathic cancer pain. [ABSTRACT FROM AUTHOR]

A recently published study in Pediatrics by Kaiser et al. (2014; Epub April 21, DOI: 10.1542/peds.2013-3171) reported that on average, over the past decade, children aged 3 to 17 were prescribed approximately 700,000 prescriptions for codeine-containing products each year in association with emergency department (ED) visits. Although, guidelines from the American Academy of Pediatrics issued warnings in 1997 and reaffirmed their concerns regarding the safety and effectiveness of codeine in 2006, it is still often prescribed for pain and cough associated with upper respiratory infection. With the impending rescheduling of hydrocodone combination products to Schedule II, physicians and mid-level prescribers may be compelled to prescribe codeine-containing products (e.g., with acetaminophen) due to reduced administrative burden and limits on Schedule II prescriptive authority for nurse practitioners and physician assistants in some states. This commentary expounds on the safety and effectiveness concerns of codeine, with a primary focus on patients in the ED setting. [ABSTRACT FROM AUTHOR]

No consensus guidelines exist for the treatment of refractory myoclonic status epilepticus or refractory myoclonus in the palliative care setting. Evidence-based guidelines for the general medical population are often neither practical nor applicable at the end of life. Many challenges, including medication availability, route of administration, monitoring, and work-up are all unique to the palliative care setting. Two patients with refractory myoclonus versus refractory myoclonic status epilepticus are described here, illustrating the challenges involved in treatment as well the need for further research for therapy in the palliative care setting. [ABSTRACT FROM AUTHOR]

Hyperbaric oxygen therapy (HBOT) is a treatment for a variety of conditions, particularly nonhealing wounds. The treatment requires the inhalation of pure oxygen in a sealed chamber that is pressurized to 1.5 to 3 times that of normal atmospheric pressure. HBOT safety protocols require all transdermal products to be removed prior to entrance into the hyperbaric chamber, and many institutional policies state that removed patches are not to be reapplied. Limited data are available regarding the use of transdermal fentanyl patches in patients undergoing HBOT. For such patients, the patch would need to be changed on a daily basis. Although the recommended dosing interval is 72 hours, many references discuss the use of 48-hour intervals in select patients, and no published reference recommends dosing intervals shorter than 48 hours. The authors evaluated the clinical safety and efficacy parameters for two patients receiving daily application of transdermal fentanyl while receiving HBOT. Patient 1 was a 47-year-old female with diabetes mellitus, sepsis, and left foot wound with toe necrosis. Complicating her management was the presence of chronic pain syndrome secondary to fibromyalgia. Patient 2 was a 70-year-old female with paralysis secondary to spinal fracture who presented with a stage IV sacral pressure ulcer, who was later diagnosed with osteomyelitis. Both patients were successfully managed with daily application of fentanyl transdermal patch. [ABSTRACT FROM AUTHOR]

The objectives of this study were to investigate whether continuous intravenous ketamine during the first 72 hours after thoracotomy could reduce the incidence and intensity of chronic postthoracotomy pain (CPTP) and to define the incidence and risk factors of CPTP. Seventy-eight patients receiving thoracotomy for lung tumor (benign or malignant) were randomly divided into two groups: ketamine group ( n = 31) and control groups ( n = 47). Patients in the ketamine group received intravenous ketamine 1 mg/kg before incision, followed by 2 μg/kg/minute infusion for 72 hours plus sufentanil patient-controlled intravenous analgesia after thoracotomy. Patients in the control group received intravenous a 0.9% normal saline and infusion plus sufentanil patient-controlled intravenous analgesia. The solutions patients received were blinded. The numerical rating scale (NRS) pain scores and the incidence and risk factors of CPTP were recorded during the first 6 months after surgery. Compared with control group, the incidence of chronic pain in the ketamine group did not decrease at 2 months (χ2 = 1.599, P = .206) and 6 months (χ2 = 0.368, P = .544) after surgery. Postoperative pain scores in the ketamine group were not significantly different from those of the control group patients at 2 months ( U = 677.5, P = .593) and 6 months ( U = 690.5, P = .680). The incidence of CPTP was 78.2% (61/78) at 2 months and 53.8% (42/78) at 6 months after surgery. Retractor used time (OR = 5.811, P = .002), inadequate acute pain control (NRS ≥ 5) (OR = 5.425, P = .048), and chemotherapy (OR = 3.784, P = .056) were independent risk factors for chronic postthoracotomy pain. The authors conclude that continuous intravenous ketamine (2 μg/kg/min) during the first 72 hours after thoracotomy was not beneficial to prevent chronic postthoracotomy pain. The independent risk factors for chronic postthoracotomy pain were retractor used time, inadequate acute pain control, and chemotherapy. [ABSTRACT FROM AUTHOR]

Neuropathic pain is common among cancer patients and often difficult to treat. This study used Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device, to treat cancer patients with pain. Patients received Scrambler therapy for 10 sessions (one daily) over a two-week period. The primary outcome was changed in pain numerical rating scale (NRS) at one month; secondary outcomes were changes in the Brief Pain Inventory and European Organization for Treatment and Cancer QLC-CIPN-20(EORTC CIPN-20), over time. Thirty-nine patients, mean age 56.5 yr, 16 men and 23 women, were treated over an 18-month period for an average of 9.3 days each. The 'now' pain scores reduced from 6.6 before treatment to 4.5 at 14 days, 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively ( p < 0.001). Clinically important and statistically significant improvements were seen in average, least, and worst pain; BPI interference with life scores, and motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed. In this single arm trial, Scrambler therapy appeared to relieve cancer-associated chronic neuropathic pain both acutely and chronically, and provided sustained improvements in many indicators of quality of life. [ABSTRACT FROM AUTHOR]

The authors investigated the treatment outcome of patients with severe interstitial pneumonia (IP) who received opioids during end-of-life care. Twenty-two consecutive patients were retrospectively evaluated before and after continuous administration of opioids for 24 hours. All subjects died within 21 days; the mean survival period after opioid administration was 5.6 days. Six of the 22 patients (27%) died within 24 hours after opioids were initiated. In the other 16 patients, respiratory rate was significantly decreased after opioid use and there was a small, nonsignificant improvement in dyspnea measured by the Borg scale without adequate evaluation and records ( n = 6). However, hypercapnia with over 10 mm Hg of Paco2 developed in two patients. Paco2 tended to be elevated after opioid use in all patients, although the change was not significant. An extremely poor outcome was attributable to the disease progression of IP in six of the patients with Pao2/FIo2 levels below 100. The other 16 patients showed both positive and negative effects as expected. Clinicians should assess dyspnea prior to opioid administration, since the purpose of the opioid administration is to relieve dyspnea. Dyspnea should be monitored and recorded in routine clinical practice, at least after hospitalization. [ABSTRACT FROM AUTHOR]

This observational study characterized medication use in the immediate postoperative period among patients undergoing total hip arthroplasty (THA) at an academic medical center, and evaluated pain (0-10 numerical pain rating scale [NPRS]; 0 = no pain, 10 = worst pain that the patient can imagine), function (Harris Hip Score [HSS] and Lower Extremity Function Scale [LEFS]), and health-related quality of life (SF-36). Study patients ( N = 115; 59% female; average age 61.3 ± 12.0 years; mean BMI of 29.9 ± 6.9 kg/m2) who underwent THA between September 1, 2008, and November 30, 2010, and met study inclusion criteria were drawn from the University of Utah Orthopedic Clinic database. The most common comorbidities in these patients were osteoarthritis, hypertension, and chronic back pain. The most frequently prescribed class of pain-related medications in the immediate postoperative period was opioids. The most common nonopioid medications were bupivacaine, celecoxib, and midazolam. Opioids and celecoxib continued to be commonly prescribed at discharge. Pain was improved at a 6-week follow-up (mean change −3.3 ± 3.3 points), as were HSS and LEFS, with mean changes of 19.9 ± 24.2 and 8.7 ± 16.9 points ( P < .01 for both), respectively. Although SF-36 scores were also improved, these scores were significantly lower relative to normative values for the US general population as well as relative to individuals having both osteoarthritis and hypertension. [ABSTRACT FROM AUTHOR]

The objective of this study was to determine the feasibility of protocol-driven human recombinant hyaluronidase (rHuPH20)-enhanced subcutaneous (SC) hydration and opioid administration in adults presenting to the emergency department (ED) with sickle cell disease acute pain episodes (SCDAPE). Adults with SCDAPE were given 150 U of rHuPH20 and normal saline subcutaneously. Opioids were administered SC every 15 minutes for 4 hours until numerical rating scale (NRS) pain intensity scores fell to <5, or Ramsay Sedation Scores were >4. Pain intensity and pain relief were recorded hourly. Total morphine equivalents and fluid volume, total pain relief (TOTPAR), patient- and physician-perceived global efficacy, patient-perceived global SC needle discomfort, physician-rated ease of needle placement, and adverse effects were noted. Ten patients (6 males, 4 females), mean age 32.9 years (23-56 years) completed the trial. Mean pain intensity scores fell 25% (from 9.2 to 6.9) from baseline and mean 4-hour TOTPAR score was 4 (maximum: 16). A mean total of 119 mg (70-170 mg) morphine equivalents and 846 mL (200-1650 mL) normal saline were administered. Mean patient and physician global perceived efficacy ratings were 3.4 and 4.2 (of 5). Patient global discomfort of SC needle presence was 2.7 (of 10), and ease of needle placement was physician rated at 4 (of 4; easiest). Patients experienced mild swelling and stinging at the SC site, and no infusion required discontinuation. The authors conclude that rHuPH20-enhanced subcutaneous hydration and opioid administration appear feasible from this pilot study. These results need confirmation in a controlled clinical trial. [ABSTRACT FROM AUTHOR]

New systematic reviews pertinent to pain and palliative care that appeared in the July 2011 issue of the Cochrane Library addressed selenium for cancer prevention, botulinum toxin for subacute/chronic neck pain, arthroscopy for temporomandibular disorders, low-dose rate brachytherapy for men with localized prostate cancer, arthroscopy for temporomandibular disorders, and home-based end-of-life care. [ABSTRACT FROM AUTHOR]

To compare the efficacy of percutaneous endoscopic gastrostomy (PEG) and nasogastric (NGT) tube administration of enteral nutrition in head and neck cancer patients undergoing curative treatment, the authors conducted a prospective study to compare nutritional outcomes, complications, and patient satisfaction. PEG patients sustained significantly less reduction in nutritional parameters, measured at 6 weeks post insertion, as compared with NGT patients. There was also a statistically significant difference between the two groups in patient's quality of life scores and complications. Comparison could not be done at 6 months because all patients were converted to PEG feeding due to the earlier findings. The authors conclude that PEG is more efficacious than NGT as a channel for nutrition in advanced head and neck cancer patients over a short duration. [ABSTRACT FROM AUTHOR]

Abnormalities in taste and smell are commonly reported in patients receiving chemotherapy and may hinder appetite, dietary intake, nutritional well-being, and quality of life. Oral zinc has been used to treat taste and smell abnormalities in several altered physiologic states, including renal failure, liver disease, head trauma, and pregnancy, with varying results. The authors conducted a double-blinded, placebo-controlled randomized clinic trial over 3 months. Eligible patients were those taking chemotherapy that had alterations in taste and/or smell. The measurement of the primary end point, improvement in altered taste and smell, was made using a 0-100 scale (100 describing no loss or distortion in taste and smell, and 0 describing the worst distortion or loss of taste and smell). Twenty-nine subjects were enrolled in each treatment group, of whom 31 were white, 26 African American, and 1 Native American. Forty-one patients were female. A wide range of cancer types was represented, with breast the most common (21 patients). The zinc dose was 220 mg orally twice daily (equivalent of 50 mg elemental zinc twice daily). There was no statistically significant improvement in loss or distortion of taste or smell with the addition of zinc. There was a trend toward improvement over time in all groups, except in the zinc group where there was a nonsignificant worsening in loss of smell over time. Zinc at standard doses did not provide significant benefit to taste or smell in patients receiving chemotherapy. [ABSTRACT FROM AUTHOR]

The objective of the current study was to determine the cost-utility of pregabalin versus duloxetine for treating painful diabetic neuropathy (PDN) using a decision tree analysis. Literature searches identified clinical trials and real-world studies reporting the efficacy, tolerability, safety, adherence, opioid usage, health care utilization, and costs of pregabalin and duloxetine. The proportions of patients reported in the included studies were used to determine probabilities in the decision tree model. The base-case model included the Food and Drug Administration (FDA)-approved doses of pregabalin (300 mg/day) and duloxetine (60 mg/day), whereas 'real-world' sensitivity analyses explored the effects over a range of doses (pregabalin 75-600 mg/day, duloxetine 20-120 mg/day). A 6-month time horizon and a US third-party payer perspective were chosen for the study. Outcomes from the model were expressed as cost per quality-adjusted life-year (QALY). In the base-case model, duloxetine cost less and was more effective than pregabalin (incremental cost −$187, incremental effectiveness 0.011 QALYs). Results from two real-world sensitivity analyses indicated that duloxetine cost $16,300 and $20,667 more per additional QALY than pregabalin. Using a decision tree model that incorporated both clinical trial and real-world data, duloxetine was a more cost-effective option than pregabalin in the treatment of PDN from the perspective of third-party payers. [ABSTRACT FROM AUTHOR]

The article presents 2012 news on pain and palliative care. The American Pain Foundation has released recommendations for pain patients which can be used when the patients travel. The American Society of Clinical Oncology has published a provisional clinical opinion statement on the integration of palliative care services into standard oncology practice. The Hospice Foundation of America has published a book on end-of-life care ethics as a companion volume for its 2012 conference.

Oral morphine elixir in the immediate release form became available in Nigeria in the year 2006 after decades of use in the treatment of cancer pain in many other countries. In order to determine the effectiveness of oral morphine in Nigerian patients, 182 patients presenting with severe cancer pain at the Radiotherapy Clinic, University College Hospital (UCH), Ibadan, Nigeria, were recruited in a prospective descriptive observational study. Information on patient's demography, diagnosis, baseline intensity and character of pain, morphine dosages, and effects were collected using a semistructured questionnaire administered at recruitment and biweekly in the follow-up period. Mean (++ SD) age of the patients was 47 (++ 14.6) years and the most common types of cancer diagnosed in the study participants included cancer of the breast and uterine cervix. The pretreatment pain intensity score mean (++ SD) was 8.09 (++ 1.51). Of the 166 patients whose data were analyzed, 84.3%% (95%% confidence interval [[CI]] 77.8-89.5%%) achieved a 3-point reduction in pain intensity using the 11-point Numerical Rating Scale at the end of the first week of treatment. Twenty-six patients (15.7%%) required adjuvant therapy. The reduction in pain intensity was maintained throughout the 3 months follow-up period, with the mean 24-hour morphine consumption of 55.54 mg in the first month and 61.54 mg in the third month. Oral morphine significantly reduced cancer pain in Nigerian patients ( P < .01). Increasing dose as required was found to enhance the effectiveness of oral morphine. [ABSTRACT FROM AUTHOR]

Timely and important studies are reviewed and commentaries provided by leading palliative care clinicians. Symptoms, interventions, and treatment-related adverse events addressed in this issue are optimizing buprenorphine antinociception with the addition of naltrexone; reliably assessing the internal state of persons with cognitive impairment, for the purpose of measuring perception of their sense of purpose; improving understanding of prognosis over time by means of early palliative care intervention in patients with non-small cell lung cancer (NSCLC); and examining reasons for cancer patients' emergency department (ED) visits and outcomes of the visits. [ABSTRACT FROM AUTHOR]

Transcutaneous electrical nerve stimulation (TENS) has existed since the early 1970s. However, randomized placebo controlled studies show inconclusive results in the treatment of chronic pain. These results could be explained by assuming that TENS elicits a placebo response. However, in animal research TENS has been found to decrease hyperalgesia, which contradicts this assumption. The aim of this study is to use quantitative sensory testing to explore changes in pain processing during sham versus real TENS in patients with chronic pain. Patients with chronic pain ( N == 20) were randomly allocated to real TENS or sham TENS application. Electrical pain thresholds (EPTs) were determined inside and outside the segment stimulated, before and after the first 20 minutes of the intervention, and after a period of 10 days of daily real/sham TENS application. Pain relief did not differ significantly for real versus sham TENS. However, by comparing time courses of EPTs, it was found that EPT values outside the segment of stimulation increased for sham TENS, whereas for real TENS these values decreased. There were, however, no differences for EPT measurements inside the segment stimulated. These results illustrate the importance of including mechanism-reflecting parameters in addition to symptoms when conducting pain research. [ABSTRACT FROM AUTHOR]

Several clinical reports showed that adverse effect profiles are not the same in morphine, oxycodone, and fentanyl. The authors investigated whether the relationship between plasma concentrations for antinociceptive effect and for various pharmacological effects differed among oxycodone, morphine, and fentanyl under controlled experimental setting using animal models. Oxycodone induced constipation and an antinociceptive effect in a similar concentration-dependent manner, whereas morphine required approximately 9-fold higher plasma concentration for antinociceptive effect compared with that for constipation when 50%% effective plasma concentration (EC50) levels were compared. The EC50 values for inhibition of behavioral activity were 2.1-, 2.7-, and 1.3-fold higher than those for antinociceptive effect in oxycodone, morphine, and fentanyl, respectively. Respiratory inhibition was observed even at higher plasma concentrations in all three opioids, and the differences in the EC50 values compared with those for antinociceptive effects were 234.5-fold (oxycodone), 233.1-fold (morphine), or 104.2-fold (fentanyl). These results showed that oxycodone, morphine, and fentanyl exhibited unique patterns of plasma concentrations required for different pharmacological effects. The different adverse effect profiles observed in a clinical setting appear to be resulted from, at least in part, distinct intrinsic pharmacological profiles among these μ-opioid receptor agonists. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 36 year old woman with metastatic colorectal cancer involving the lungs, liver and peritoneum. A discussion of a decision which was made to transition the patient from intravenous hydromorphone to intravenous methadone, and of patient monitoring which took place after the transition, is presented.

Negative preconceived beliefs about the benefits of morphine use are frequently seen in hospitalized patients and may be associated with reports of severe pain, poor patient satisfaction, impaired rehabilitation, and possibly more chronic postsurgical pain. In some patients, providing information through instructive leaflets may modify negative beliefs that limit proper medication use. The purpose of this study was to determine whether the morphine-related information provided through leaflets during the postoperative period led to increased use of morphine and lower pain scores in patients using patient-controlled analgesia. One hundred patients scheduled for surgery were randomly assigned to the experimental ( n == 53) or control group ( n == 38). Patients included in the former group received detailed information on morphine; those in the latter group received only general information on postoperative acute pain. The results indicated that during the immediate postoperative period, morphine use was directly associated with pain intensity and satisfaction with pain management and inversely related with side effects. These results show that pain intensity is the most relevant issue in the decision to use morphine. Information leaflets did not change morphine consumption. [ABSTRACT FROM AUTHOR]

Methylnaltrexone is a methylated form of the mu-opioid antagonist naltrexone that blocks peripheral effects of opioids without affecting centrally mediated analgesia. The authors conducted a 3-month open-label extension trial of methylnaltrexone in patients with advanced illness and opioid-induced constipation (OIC). Following completion of a 2-week double-blind (DB) trial, 82 patients with OIC who did not respond to laxatives received subcutaneous (SC) methylnaltrexone as needed for up to 3 months. Patients received 0.15 mg/kg as a first dose, adjusted to 0.3 mg/kg or 0.075 mg/kg as needed (maximum of one dose per 24 hours). Mean laxation response (rescue-free bowel movement within 4 hours) rates (DB phase, months 1, 2, 3 open-label phase) were 45.3%%, 45.5%%, 57.7%%, and 57.3%%, respectively, for patients treated with DB methylnaltrexone and 10.8%%, 48.3%%, 47.6%%, and 52.1%%, respectively, for patients treated with DB placebo. Median time to laxation among responders was 45 minutes (range 0--4 hours) for all doses. Approximately 50%% of patients reported improvement in constipation distress. Patient and investigator global clinical impression of change scores also improved. There were minimal changes in pain scores and opioid withdrawal symptoms. Adverse events included abdominal pain and nausea, mostly mild or moderate in severity. SC methylnaltrexone administered PRN (as needed) for up to 3 months continued to rapidly induce laxation in advanced illness patients with OIC. [ABSTRACT FROM AUTHOR]

The article presents news on pain and pharmacology. An initiative called the Analgesic Clinical Trials Innovations, Opportunities, and Networks (ACTION) initiative is being developed to streamline the discovery and development process for new analgesic drugs. Research published in 2011 in an online publication investigated pharmacological treatments for fatigue in diseases such as cancer. In 2011 the U.S. Food and Drug Administration approved the postherpetic neuralgia drug gabapentin.

Pain is a major concern of cancer patients and a significant problem for therapy. Pain can become a predominant symptom in advanced cancers. In this open-label clinical study, the authors have treated 26 cancer patients who have been declared as terminal without the option of conventional treatment. These patients suffered from high levels of pain that was poorly managed by all available interventional approaches recommended by World Health Organization (WHO) guideline. The results indicate  that intravenous infusion of dimethyl sulfoxide (DMSO) and sodium bicarbonate (SB) solution can be a viable, effective, and safe treatment for refractory pain in cancer patients. These patients had pain due to the disease progression and complication of chemotherapy and radiation. Moreover, the preliminary clinical outcome of 96-day follow-up suggests that the application of DMSO and SB solution intravenously could lead to better quality of life for patients with nontreatable terminal cancers. The data of this clinical observation indicates that further research and application of the DMSO and SB combination may help the development of an effective, safe, and inexpensive therapy to manage cancer pain. [ABSTRACT FROM AUTHOR]

Qutenza is a high-potency capsaicin (8%%) topical patch, labeled for treating pain associated with postherpetic neuralgia (PHN). Qutenza decreases pain sensation by reducing transient receptor potential vanilloid 1 (TRPV1) expression and decreasing the density of epidermal nerve fibers in the application area. Systemic absorption from Qutenza is low. Qutenza has not been directly compared to any other medications for the treating PHN. Two pivotal clinical trials compared Qutenza to a control patch (0.04%% capsaicin) in PHN. The primary endpoint of both trials was the reduction in numeric pain rating scale (NPRS) score. Qutenza reduced pain from baseline to weeks 2 to 8 (29.6%% and 32%% reductions) compared to control (19.9%% and 24.4%% reductions; P ≤≤ .01). The improvement in NPRS scores persisted, with score reductions greater with Qutenza (29.9%% and 32.3%% reductions) compared to control (20.4%% and 25%% reductions; P ≤≤ .03) for the period 2 to 12 weeks. Safety and efficacy of capsaicin 8%% has been demonstrated in open-label trials for up to 48 weeks. The most common adverse drug reactions occurring with capsaicin 8%% are application site erythema (63%%) and application site pain (42%%). Some patients experienced transient increases in blood pressure during Qutenza application. Qutenza must be administered by a physician or under the close supervision of a physician. Prior to application, pretreat the affected area with a topical anesthetic to reduce application site pain. Some patients may require systemic analgesics during and after treatment for treatment-associated pain. Applications of Qutenza can be repeated no sooner than once every 3 months, as needed. [ABSTRACT FROM AUTHOR]

Dual-modality management of failed back surgery syndrome (FBSS) using a combination of an intrathecal opioid pump (IOP) and spinal cord stimulator (SCS) has not been investigated. The authors performed a retrospective review of 11 patients (8 men, 3 women) with FBSS who underwent nonsimultaneous surgical implantation of both an IOP and a thoracic SCS. Chart review and structured phone interviews were performed to obtain follow-up. Of the two modalities, 3 patients (27%) had an IOP placed first and 8 patients (73%) had a SCS implanted initially. Mean follow-up was 41.7 months (3-97 months). All 11 patients (100%) stated that the dual-modality treatment improved their quality of life and all continue to use both an IOP and SCS for pain control. Six patients (55%) felt that the IOP provided superior pain relief as compared to the SCS, 4 patients (36%) felt that IOP and SCS provided a similar degree of pain relief, and 1 patient (9%) said the SCS provided better pain relief than the IOP. Nine patients (82%) claimed that dual-modality treatment improved their activities of daily living. Nine patients (82%) reported that the combination of IOP and SCS treatment had allowed them to significantly decrease their oral pain medication requirements. Seven patients (64%) had hardware-related complications which required surgery; of this group, 2 patients (18%) needed more than one operation. Six patients (55%) had minor postoperative complications, which were managed nonoperatively. Overall, 10 patients (91%) were glad that they had implantation of both an IOP and SCS and would recommend this combined therapy to other patients. Dual neuroaugmentative treatment with an IOP and thoracic SCS can be safely performed and may provide satisfactory pain relief in appropriately selected patients with FBSS. [ABSTRACT FROM AUTHOR]

Evidence supporting the efficacy of long-term opioid therapy for chronic noncancer pain is scarce. However, weak evidence suggests that those who are able to continue opioids long-term experience clinically significant pain relief. Fear of opioid abuse or addiction should not impede the prescribing of opioids if the patients are carefully selected and monitored. In patients taking opioids who experience intolerable side effects or unsatisfactory pain relief, alternatives should be sought as soon as possible. This report is adapted from paineurope 2014; Issue 1, ©Haymarket Medical Publications Ltd., and is presented with permission. paineurope is provided as a service to pain management by Mundipharma International, Ltd., and is distributed free of charge to healthcare professionals in Europe. Archival issues can be accessed via the Web site: , at which European health professionals can register online to receive copies of the quarterly publication. [ABSTRACT FROM AUTHOR]

A case of severe neuropathic pain in a middle-aged Swiss patient that did not respond well to several routine approaches is described. A topical 8% capsaicin patch was effective. The use, limitations, efficacy, and mechanism of action for this pharmacotherapy are discussed. Perspectives on this case are provided by consultants from the United Kingdom and Sweden are provided. This feature is adapted from paineurope 2011; Issue 4, ©Haymarket Medical Publications Ltd., and is presented with permission. paineurope is provided as a service to pain management by Mundipharma International, Ltd., and is distributed free of charge to health care professionals in Europe. Archival issues can be accessed via the Web site: http://www.paineurope.com, at which European health professionals can register online to receive copies of the quarterly publication. [ABSTRACT FROM AUTHOR]

Acetaminophen injection is an antipyretic and analgesic agent recently marketed in the United States as Ofirmev. A recent review published in the Journal of Pain & Palliative Care Pharmacotherapy focused on the labeled uses of acetaminophen injection in the United States. A variety of studies were excluded that may be of interest to clinicians. This addendum provides these citations and further insight into the strategy used to develop the review. Acetaminophen injection represents another agent for multimodal pain management. [ABSTRACT FROM AUTHOR]

This commentary relates to an article entitled 'Off-Label Prescribing of Medications for Pain: Maintaining Optimal Care at an Intersection of Law, Public Policy, and Ethics,' which appears in the same journal issue. Off-label prescribing and off-label marketing of drugs are differentiated. Vulnerability of pain patients with off-label prescribing is noted as is the lack of data on benefits and risks of the practice. The influence of the pharmaceutical industry in off-label prescribing is discussed. A lack of transparency when communicating with patients about off-label drug use is a concern. [ABSTRACT FROM AUTHOR]

Dr. Howard Brody, a leader in bioethics and medical humanities, describes how human touch impacts pain management outcomes. The symbolism of positive meaning versus negative meaning and how they effect patients' perception of pain are explored. [ABSTRACT FROM AUTHOR]

Queries from European physicians about analgesic pharmacotherapy and responses from the author are presented. Topics addressed in this issue pertain to concerns about opioid-induced immunosuppression, nerve blocks in migraine headache management, and causes of pain exacerbations in ankylosing spondylitis [ABSTRACT FROM AUTHOR]

The article presents an overview of a systematic review by R. A. Moore et al. which was published in the Cochrane Library on September 7, 2011, was titled “Single dose oral analgesics for acute postoperative pain in adults,” and concluded that no single analgesic is best for postoperative pain in all patients. A brief commentary on the review is offered.

Fulfilling information needs is one of the keys to success in palliative care. A comprehensive palliative care offered in continuity not only helps people in coping with the illness but also relieves pain and other distresses. Primary physician or any doctor on whom the patient rely should be in the care team for effective management. This is the gist of the narrative shared by a family member in a continuity of cancer care workshop. Perhaps the hospice team offered more than enough to adjust and accept dying in a safe environment, for which the family remained grateful forever. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which is concerned with urine drug screening.