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Background The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient’s and caregiver’s quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain. Methods/design This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients. Discussion This study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients’ quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes. Trial registration ChiCTR-INC-16008075 . Registered on 8 March 2016.

Objective The aim of this study was to adapt the original English Breakthrough Pain Assessment Tool (BAT) into a Chinese version (BAT-C), following Beaton’s cross-cultural adaptation guidelines, and evaluate its psychometric properties among cancer patients, thereby providing a foundation for the standardized and evidence-based assessment of breakthrough pain in this population. Methods This study employed a cross-sectional design for psychometric validation. The English BAT underwent cultural adaptation according to Beaton’ s cross-cultural adaptation framework to develop the BAT-C. A convenience sampling strategy was utilized to recruit 310 cancer patients with breakthrough pain from four tertiary hospitals in Hebei Province, with data collected to examine the psychometric properties (reliability and validity) of the BAT-C. Results Pre-test analysis revealed no significant ceiling or floor effects. The BAT-C comprises nine items organized into two dimensions—Severity and Impact of Breakthrough Pain, Onset Characteristics and Medication Effectiveness—alongside five open-ended items. Item-level content validity indices (I-CVI) ranged from 0.833 to 1.000, while the scale-level content validity index (S-CVI/Ave) reached 0.976. Exploratory factor analysis extracted two common factors explaining 82.521% of the cumulative variance. Confirmatory factor analysis confirmed acceptable model fit, with indices as follows: χ²/df = 1.733, RMSEA = 0.061, CFI = 0.988, TLI = 0.983, IFI = 0.988, and GFI = 0.953. Convergent validity was confirmed by composite reliability (CR) values of 0.927 and 0.900, and average variance extracted (AVE) values of 0.724 and 0.648. The scale demonstrated a Cronbach’ s α of 0.869 (95% CI: 0.85–0.89, SE: 0.012), with dimension-specific coefficients of 0.937 and 0.861. McDonald’ s ω was 0.947, with a hierarchical ω of 0.675; the Spearman-Brown coefficient was 0.828. Known-groups validity analysis indicated that, after controlling for confounding variables, the BAT-C significantly differentiated patients across ECOG performance statuses ( P  < 0.05, partial η² = 0.021). Conclusion The BAT-C exhibited robust psychometric properties in this sample, providing preliminary support for its clinical utility as an assessment instrument for breakthrough pain in Chinese cancer patients; however, further validation is warranted in larger and more diverse populations.

Background and ObjectivesAlthough data exist for the efficacy of intrathecal therapy (ITT), there are no prospective data on patient-controlled intrathecal analgesia (PCIA) in refractory cancer pain. This study examines the effect of PCIA on cancer symptom scores, patient satisfaction, and analgesic efficacy with an emphasis on breakthrough pain (BTP).MethodsNinety-eight patients with refractory cancer pain prospectively completed questionnaires including the MD Anderson Symptom Inventory and a BTP survey before and after the implantation of an intrathecal pump.ResultsFifty-eight patients were included in the study group. Average “worst” pain scores decreased from 8.32 (SD, 1.73) pre-ITT to 4.98 (SD, 2.92) post-ITT, P < 0.001. Severe pain (numerical rating score ≥7) decreased from 84.2% to 35.2% (P < 0.001). Mean daily morphine equivalent dosing decreased from 805.3 mg/d to 128.2 mg/d, with 65.5% of patients discontinuing all nonintrathecal opioids. The mean MD Anderson Symptom Inventory symptom severity score decreased from 4.98 to 3.72 (P < 0.0001), and the symptom interference score from 6.53 to 4.37 (P < 0.001). Pain reduction was 46.8% with pre-ITT breakthrough medications and 65.2% with PCIA (P < 0.001). Median time to onset was 30 minutes with pre-ITT breakthrough medications and 10 minutes with PCIA (P < 0.001). Patient-controlled intrathecal analgesia, compared with conventional BTP medications, was “a lot better” in 60.7% and “a little better” in 28.6%. Overall pain control satisfaction was also improved, with 78.2% “a lot better” and 10.9% “I have no pain.”ConclusionsIn patients with poorly controlled cancer pain, PCIA is associated with improved pain control, improved cancer-related symptoms, and high satisfaction. Compared with conventional BTP regimens, PCIA provides superior analgesia and a 3-fold faster onset of action.

Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: \"1-pain severity and impact\" and \"2-pain duration and medication\". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Clinical management of breakthrough cancer pain (BTcP) is still not satisfactory despite the availability of effective pharmacological agents. This is in part linked to the lack of clarity regarding certain essential aspects of BTcP, including terminology, definition, epidemiology and assessment. Other barriers to effective management include a widespread prejudice among doctors and patients concerning the use of opioids, and inadequate assessment of pain severity, resulting in the prescription of ineffective drugs or doses. This review presents an overview of the appropriate and inappropriate actions to take in the diagnosis and treatment of BTcP, as determined by a panel of experts in the field. The ultimate aim is to provide a practical contribution to the unresolved issues in the management of BTcP. Five ‘things to do’ and five ‘things not to do’ in the diagnosis and treatment of BTcP are proposed, and evidence supporting said recommendations are described. It is the duty of all healthcare workers involved in managing cancer patients to be mindful of the possibility of BTcP occurrence and not to underestimate its severity. It is vital that all the necessary steps are carried out to establish an accurate and timely diagnosis, principally by establishing effective communication with the patient, the main information source. It is crucial that BTcP is treated with an effective pharmacological regimen and drug(s), dose and administration route prescribed are designed to suit the particular type of pain and importantly the individual needs of the patient.

IntroductionBreakthrough pain is common in children and adults with cancer and other conditions, including those approaching end-of-life, although it is often poorly managed, possibly partly due to a lack of validated assessment tools. This review aims to (1) identify all available instruments measuring breakthrough pain in infants, children, adolescents or adults and (2) critically appraise, compare and summarise the quality of the psychometric properties of the identified instruments using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria.Methods and analysisTwo searches will be carried out between October 2019 and January 2020, one for each aim of the review. The Cochrane Library, International Prospective Register of Systematic Reviews, Embase, Cumulative Index of Nursing and Allied Health Literature, Medical Literature Analysis and Retrieval System Online (MEDLINE), PsycINFO, Web of Science Core Collection, Google Scholar, the ProQuest Dissertations & Theses Database, Evidence Search and OpenGrey databases will be searched from database inception until the date the search is conducted. Reference lists of eligible articles will be screened and authors in the field contacted. For search 1, articles will be screened by two reviewers by abstract, and full-text where necessary, to identify if a breakthrough pain assessment was used. Search 2 will then be conducted to identify studies evaluating measurement properties of these assessments. Two reviewers will screen articles from search 2 by title and abstract. All potentially relevant studies will be screened by full text by both reviewers. For search 2, data will be extracted in parallel with the quality assessment process, as recommended by COSMIN. Two reviewers will assess methodological quality using the COSMIN Risk of Bias checklist and the COSMIN updated criteria for good measurement properties. Findings will be summarised and, if possible, data will be pooled using meta-analysis. The quality of the evidence will be graded and summarised using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) guidelines.Ethics and disseminationResults of this review will be submitted for publication in a peer review journal and presented at conferences.PROSPERO registration numberCRD42019155583.

With the technological advances in cancer diagnosis and treatment, the survival rates for patients with cancer are prolonged. The issue of figuring out how to improve the life quality of patients with cancer has become increasingly prominent. Pain, especially bone pain, is the most common symptom in malignancy patients, which seriously affects the life quality of patients with cancer. The research of cancer pain has a breakthrough due to the development of the animal models of cancer pain in recent years, such as the animal models of mouse femur, humerus, calcaneus, and rat tibia. The establishment of several kinds of animal models related to cancer pain provides a new platform in vivo to investigate the molecular mechanisms of cancer pain. In this review, we focus on the advances of cancer pain from bone metastasis, the mechanisms involved in cancer pain, and the drug treatment of cancer pain in the animal models.

Fentanyl buccal soluble film (Onsolis ® , Breakyl ® , Painkyl™) comprises two layers: a mucoadhesive layer containing the active drug, and an inactive layer with the aim of preventing the diffusion of fentanyl into the oral cavity. It is approved in several countries worldwide, including the USA and those of the EU, for the management of breakthrough cancer pain in opioid-tolerant, adult patients with cancer. This article reviews the pharmacological properties of fentanyl buccal soluble film and its clinical efficacy and tolerability in these patients. Fentanyl buccal soluble film provides an additional option for transmucosal delivery of fentanyl, with approximately half of the dose undergoing an initial, rapid absorption via the buccal mucosa (accounting for its high bioavailability). In clinical trials, fentanyl buccal soluble film was associated with significant improvements in pain intensity scores versus placebo and was generally well tolerated. The most common adverse events were typical opioid-associated adverse events, such as nausea and vomiting. Fentanyl buccal soluble film is a useful option for the treatment of breakthrough cancer pain in opioid-tolerant patients.

•Breakthrough pain (BTP) shows variable prevalence among chronic pain patients.•BTP diagnostic/prognostic tools are lacking; this hampers BTP management.•The validated IQ-BTP enables BTP recognition and its likelihood definition.•The 3 BTP prognostic classes have clinical and epidemiological implications. Breakthrough pain (BTP) shows variable prevalence in different clinical contexts of cancer and non-cancer patients. BTP diagnostic tools with demonstrated reliability, validation and prognostic capability are lacking. We report the development, psychometric and validation properties of a diagnostic/prognostic tool, the IQ-BTP, for BTP recognition, its likelihood and clinical features among chronic-pain (CP) patients. n=120 consecutive mixed cancer/non-cancer CP in/outpatients. Development, psychometric analyses and formal validation included: Face/Content validity (by ‘experts’ opinion and assessing the relationship between the IQ-BTP classes and criteria derived from BTP operational-case-definition); Construct validity, by Principle Component Analysis (PCA); and the strength of Spearman correlation between IQ-BTP classes and the Brief Pain Inventory (BPI) items; Reliability, by Cronbach's alpha statistics. Associations with clinical/demographic moderators were assessed applying χ2 analysis. Potential-BTP was found in 36.7% of patients (38.4% of non-cancer and 32.4% of cancer patients). Among these the likelihood for BTP diagnosis was ‘high’ in 25%, ‘intermediate’ in 41% and, ‘low’ 34% of patients. Analyses showed significant differences between IQ-BTP classes and between the latter BPI pain-item scores. Correlation between IQ-BTP classes and BPI items was moderate. PCA and scree test identified 3 components accounting for 62.3% of the variance. Cronbach's alpha was 0.71. The IQ-BTP showed satisfactory psychometric and validation properties. With adequate feasibility it enabled the allocating of cancer/non-cancer CP patients in three prognostic classes. Results are sufficient to warrant a subsequent impact study of the IQ-BTP as prognostic model and screening tool for BTP in both CP populations.

This study sought to explore the association between physician practice patterns and patient education, with a focus on breakthrough cancer pain (BTcP). A nationwide online survey was conducted by 92 Korean physicians. Thirteen questions on Korean physician’s assessment, prescription, patient education practices, and knowledge regarding BTcP were administered. Based on their responses, physicians were divided using two methods: (1) by their patient education practices, where the “education group” always explained the distinction between background pain and BTcP and the “less education group” which explained it less frequently; and (2) by their definition of BTcP, as occurring “after control of background pain” or “regardless of background pain.” We compared practice patterns using Fisher’s exact test or Student’s t test and performed multiple logistic regression analysis. The “education group” (65 physicians, 70.7 %) was more likely than the “less education group” to assess BTcP meticulously (odds ratio [OR] 17.13, 95 % confidence interval [CI] 4.98–58.94), prepare rescue medications in advance (OR 3.67, 95 % CI 1.36–9.90), and give explicit instructions regarding medications (OR 36.68, 95 % CI 5.63–239.15). Physicians who defined BTcP as occurring “after control of background pain” were more likely to explain how to take rescue medication (P < 0.05) than physicians who defined BTcP as occurring “regardless of background pain.” Korean physicians’ BTcP practice patterns may be affected by whether they consistently educate patients on the distinction between background pain and BTcP, regardless of their knowledge of the definition of BTcP.