Exploring the experiences of a community palliative care team as services were adapted to meet the demand of the COVID-19 pandemic.

During COVID-19, it was critical that services adapted to meet the high demands of the pandemic. This qualitative study explores the experiences of several staff members of the community palliative care team, as they adapted the delivery of their services to such pressures. Semi-structured interviews via a virtual platform were conducted and four themes were identified: service development, communication, inter-professional relationships and support mechanisms. The participants supported the change in service delivery and use of technology to triage patients. The participants also reported improved collaboration and patient care-coordination, and enhanced support mechanisms used by the team helped sustain resilience and wellbeing. Although challenging, the team embraced the changes and described improved collaboration and coordination of patient care.

Development and validation of the breakthrough pain assessment tool (BAT) in cancer patients.

CONTEXT: The successful management of breakthrough pain depends on a combination of adequate assessment, appropriate (individualized) treatment, and adequate re-assessment. Currently, there is no fully validated clinical assessment tool for breakthrough pain in cancer patients. OBJECTIVES: The aim of this project was to develop and validate a breakthrough pain assessment tool (the BAT) for use in the clinical setting. METHODS: The content of the BAT was determined by reviewing the medical literature, conducting a Delphi process with experts in breakthrough pain and/or pain assessment and conducting semi-structured interviews with cancer patients with breakthrough pain. The tool was then subjected to a series of standard psychometric tests to assess its factor structure, validity (i.e., content validity, construct validity), reliability (i.e., internal consistency, test-retest reliability), and responsiveness to change. RESULTS: The BAT comprised two pages with 14 questions. Factor analysis confirmed the presence of two underlying factors. Psychometric testing confirmed that the tool is valid, reliable, and responsive to change. CONCLUSION: This study provides initial evidence for the validity and reliability of the breakthrough pain assessment tool which may be used to facilitate the management of patients with breakthrough cancer pain in the clinical setting.

A network meta-analysis of the efficacy of opioid analgesics for the management of breakthrough cancer pain episodes.

CONTEXT: With many medications available for the management of breakthrough cancer pain (BTCP), physicians may require additional guidance in selecting an appropriate medication to suit an individual patient's needs. OBJECTIVES: To identify all the evidence and assess the relative clinical value of currently approved BTCP medications. METHODS: Following a systematic literature search (2007-2010), the results of 10 randomized controlled trials investigating the effects of BTCP medications (intranasal fentanyl spray [INFS], fentanyl pectin nasal spray, fentanyl sublingual tablets, fentanyl buccal soluble film, fentanyl buccal tablets, oral transmucosal fentanyl citrate, and morphine sulfate immediate release) were synthesized using a network meta-analysis. The main outcome was pain intensity difference (PID) relative to placebo up to 60 minutes after the intake of medication. RESULTS: INFS, fentanyl pectin nasal spray, fentanyl buccal tablet, and oral transmucosal fentanyl citrate showed greater PIDs relative to placebo than other BTCP medications 15 minutes after intake. All other medications showed greater PIDs relative to placebo at 30 minutes, except morphine sulfate immediate release, which did not show efficacy over placebo until 45 minutes. Only INFS produced clinically meaningful pain relief (absolute PID ≥2) at 15 minutes. CONCLUSION: From current evidence, although all BTCP medications provided pain relief within the time frames assessed, transmucosal fentanyl medications achieved a greater level of pain relief in a shorter time frame than placebo or oral morphine.

Opioids for the management of breakthrough pain in cancer patients.

BACKGROUND: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 1, 2006). Breakthrough pain is a transient exacerbation of pain that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger despite relative stable and adequately controlled background pain. Breakthrough pain usually related to background pain and is typically of rapid onset, severe in intensity and generally self limiting with a mean duration of 30 minutes. Breakthrough pain has traditionally been managed by the administration of supplemental oral analgesia (rescue medication) at a dose proportional to the total around-the-clock (ATC) opioid dose. OBJECTIVES: To determine the efficacy of opioid analgesics given by any route, used for the management of breakthrough pain in patients with cancer, and to identify and quantify, if data permitted, any adverse effects of this treatment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and trial registries in January 2005 for the original review, and again on 6 February 2013 for this update. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of opioids used as rescue medication against active or placebo comparator in patients with cancer pain. Outcome measures sought were reduction in pain intensity measured by an appropriate scale, adverse effects, attrition, patient satisfaction and quality of life. We applied no language restrictions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected and examined eligible studies. We retrieved full text if any uncertainty about eligibility remained. We screened non-English texts. We conducted quality assessment and data extraction using standardised data forms. We compared drug and placebo dose, titration, route and formulation and recorded details of all outcome measures (if available). MAIN RESULTS: The original review included four studies (393 participants), all concerned with the use of oral transmucosal fentanyl citrate (OTFC) in the management of breakthrough pain. Two studies examined the titration of OTFC, one study compared OTFC versus normal-release morphine and one study compared OTFC versus placebo.Fifteen studies (1699 participants) met the inclusion criteria for this update. All studies reported on the utility of seven different transmucosal fentanyl formulations, five of which were administered orally and two nasally. Eight studies compared the transmucosal fentanyl formulations versus placebo, four studies compared them with another opioid, one study was a comparison of different doses of the same formulation and two were randomised titration studies. Oral and nasal transmucosal fentanyl formulations were an effective treatment for breakthrough pain. When compared with placebo or oral morphine, participants gave lower pain intensity and higher pain relief scores for transmucosal fentanyl formulations at all time points. Global assessment scores also favoured transmucosal fentanyl preparations. One study compared intravenous with the transmucosal route and both were effective. AUTHORS' CONCLUSIONS: Oral and nasal transmucosal fentanyl is an effective treatment in the management of breakthrough pain. The RCT literature for the management of breakthrough pain is relatively small. Given the importance of this subject, more trials, including head-to-head comparisons of the available transmucosal fentanyl formulations are required.

Breakthrough cancer pain: an observational study of 1000 European oncology patients.

CONTEXT: Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. OBJECTIVES: The aim of this study was to characterize breakthrough pain in a diverse population of cancer patients. METHODS: The study involved 1000 cancer patients from 13 European countries. Patients were screened for breakthrough pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their pain. RESULTS: Of the 1000 patients, 44% reported incident pain, 41.5% spontaneous pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident pain being five minutes (P < 0.001). The median duration of untreated episodes was 60 minutes, with the median for patients with incident pain being 45 minutes (P = 0.001). Eight hundred six patients stated that pain stopped them doing something, 66 that it sometimes stopped them doing something, and only 107 that it did not interfere with their activities. Patients with incident pain reported more interference with walking ability and normal work, whereas patients with spontaneous pain reported more interference with mood and sleep. As well, 65.5% of patients could identify an intervention that improved their pain (29.5%, pharmacological; 23%, nonpharmacological; 12%, combination). Regarding medications, 980 patients were receiving an opioid to treat their pain, although only 191 patients were receiving a transmucosal fentanyl product licensed for the treatment of breakthrough pain. CONCLUSION: Breakthrough cancer pain is an extremely heterogeneous condition.

Evidence-based treatment of cancer-related breakthrough pain with opioids.

Opioids are considered important analgesics in the treatment armamentarium for moderate-to-severe background cancer pain. The past decade has seen clinical trials of transmucosal opioid formulations for breakthrough pain in cancer (BTPc), beginning with oral transmucosal fentanyl citrate (OTFC), followed by fentanyl buccal tablet and intranasal fentanyl spray, and most recently sublingual fentanyl tablet, fentanyl buccal soluble film, and fentanyl pectin nasal spray. During that time, enough rigorous evidence has accumulated to support the development of recommendations on treating BTPc with transmucosal formulations. This article describes the randomized controlled trials that have led to the support of the use of transmucosal fentanyl therapies for BTPc, starting in 1999 with OTFC formulations through to the end of 2011. Although oral opioids have been used for historical reasons, evidence supports the use of intravenous morphine or transmucosal fentanyl for treating BTPc, regardless of the opioid being taken to manage background pain. Furthermore, most studies have found no meaningful relationship between the effective dose of transmucosal opioid and the around-the-clock scheduled medication nor the previous rescue medication. The accumulated evidence shows that transmucosal fentanyl formulations provide a rapid effect on BTPc, with adverse events typical of opioids.

Fentanyl sublingual spray for breakthrough pain in cancer patients.

Breakthrough pain is a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. Typically, breakthrough pain has a fast onset and short duration, and a significant impact on patients' quality of life. Normal-release oral opioids are the traditional pharmacological approach for patients who are receiving an around the clock opioid regimen; however, their onset and duration of action may not be suitable for treating many breakthrough pains. Efforts to provide nonparenteral opioid formulations that could provide more rapid, and more effective, relief of breakthrough pain have led to the development of transmucosal opioid formulations including fentanyl sublingual spray (FSLS). This is a formulation of fentanyl available in doses of 100, 200, 400, 600, and 800 µg strengths approved for the management of breakthrough pain in adult cancer patients already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Published pharmacokinetic, efficacy, tolerability, and safety data suggest that FSLS has a valuable role to play in the symptomatic pharmacological management of breakthrough pain. The effective dose of FSLS is determined by titration according to the needs of the individual patient.

Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC.

Here we provide the updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain. The update was undertaken by the European Palliative Care Research Collaborative. Previous EAPC guidelines were reviewed and compared with other currently available guidelines, and consensus recommendations were created by formal international expert panel. The content of the guidelines was defined according to several topics, each of which was assigned to collaborators who developed systematic literature reviews with a common methodology. The recommendations were developed by a writing committee that combined the evidence derived from the systematic reviews with the panellists' evaluations in a co-authored process, and were endorsed by the EAPC Board of Directors. The guidelines are presented as a list of 16 evidence-based recommendations developed according to the Grading of Recommendations Assessment, Development and Evaluation system.

Newer generation fentanyl transmucosal products for breakthrough pain in opioid-tolerant cancer patients.

Oral normal-release morphine has long been considered the gold-standard treatment for cancer breakthrough pain. However, its relatively long time to analgesic onset, delay in maximal analgesic effect and prolonged duration of action make it unsuitable for the management of breakthrough pain episodes. These limitations led to the development of an oral transmucosal formulation of the fast-acting opioid fentanyl (oral transmucosal fentanyl citrate [OTFC] lozenge on a plastic handle; Actiq®), which has been shown to produce more rapid and effective pain relief than oral morphine. However, the formulation itself has some limitations. Consequently, investigators have continued to develop other, newer generation, transmucosal formulations of fentanyl to further improve the management of breakthrough pain. Recently, five such compounds (Effentora®/Fentora®, Abstral®, Instanyl®, Breakyl®/OnsolisTM and PecFent®) have been concurrently approved in Europe and/or the US, and have documented efficacy in quickly relieving breakthrough pain episodes. All of the available pivotal efficacy trials of these agents are randomized, double-blind comparisons with placebo. There are no head-to-head trials comparing any of the newer transmucosal formulations with each other. Only one non-pivotal study of intranasal fentanyl spray used a transmucosal preparation as an active comparator. However, that comparator was OTFC, not one of the newer transmucosal products. Close examination of the existing trials assessing these newer transmucosal preparations reveals significant variation in many study parameters, such as patient selection criteria, severity of breakthrough pain episodes, proportions of patients with a neuropathic pain component, titration protocols, choice of the primary endpoints, protocols for repeat dosing and rescue medication, the separation of treated episodes and the extent of the placebo response, all of which may have affected efficacy results. It is therefore difficult to evaluate the relative efficacies of these treatments on the basis of the available trials. Furthermore, given the differences in design between studies, the value of any potential meta-analyses including these trials would likely be limited. Blinded head-to-head comparisons of new transmucosal fentanyl preparations would be the only way to conclusively determine comparative effectiveness, but given the impracticalities of conducting such studies, these are unlikely.

Opioids for the management of breakthrough cancer pain in adults: a systematic review undertaken as part of an EPCRC opioid guidelines project.

The usual management of cancer related breakthrough pain is with supplemental doses of analgesics (commonly opioids) at a dose proportional to the total around-the-clock opioid dose. The aim of this review, undertaken as part of a European Palliative Care Research Collaborative (EPCRC) project, to update the EAPC guidelines on opioid analgesics in cancer pain was to determine the evidence for the utility of opioids in the management of breakthrough pain in patients with cancer. Randomized controlled trials of opioids used as rescue medication were identified using electronic search strategies. Outcome measures sought were reduction in pain intensity measured by an appropriate scale, adverse effects, attrition, and patient satisfaction. The date of the final search was 31 July 2009. Eight studies (790 patients) met the inclusion criteria. Most studies investigated rescue medication delivery via the buccal or nasal transmucosal routes. Intravenous morphine has been compared with the transmucosal route and the two found to be effective. The oral route has not been formally tested although found to be an inferior comparator in one study. Most studies showed no meaningful relationship between the effective dose of transmucosal opioid and the around-the-clock scheduled medication or the previous rescue medication, although one study found a fixed proportion of either intravenous morphine or transmucosal fentanyl to be efficacious.

Assessing the impact of breakthrough cancer pain.

Breakthrough pain is a transient exacerbation of pain that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger despite relative stable and adequately controlled background pain. Breakthrough pain is a common and distinct component of cancer pain and is typically of rapid onset, severe in intensity, and generally self-limiting with an average duration of 30-60minutes. Despite the self-limiting nature of breakthrough pain, it can place significant physical, psychological, and economic burdens on both patients and their carers. Patients with breakthrough pain are often less satisfied with their analgesic therapy, they have decreased functioning because of their pain, and may also experience social and psychosocial consequences, such as increased levels of anxiety and depression. Successful management of breakthrough pain is best achieved by a thorough assessment which includes determining the severity, pathophysiology, and aetiology of the pain and takes into account both background and breakthrough pains while considering whether the underlying disease, co-morbidities or precipitating events are amenable to interventions. The features of breakthrough pain and the challenges it presents to patients, their carers, and health professionals are illustrated with a case study.

Multi-centre European study of breakthrough cancer pain: pain characteristics and patient perceptions of current and potential management strategies.

This study involved 320 cancer patients from four Northern European countries. Patients with breakthrough pain were questioned about the characteristics of their pain, the current management of their pain, and the acceptability/utility of alternative routes of administration. The median number of episodes was 3/day. Forty-four percent patients reported incident-type pain, 39% spontaneous-type pain, and 17% a combination of these pains. The median duration was 60 min, and the median time to peak intensity was 15 min. Three percent patients reported "mild" pain, 37% "moderate" pain, and 60% "severe" pain. Ninety percent patients stated that the pain interfered with their daily activities. All patients were using opioids as rescue medication (mainly oral morphine/oxycodone), whilst 28% patients were using non-opioids, and 50% patients were using non-pharmacological interventions. Only 55% patients took rescue medication every time they experienced breakthrough pain. Sixty-five percent patients would definitely consider using an oral transmucosal product; patients from Denmark were less likely to answer positively, and a positive response was associated with previous use of the route for breakthrough pain. Seventy-three percent patients reported regular oral problems. Forty-two percent patients would definitely consider using an intranasal product, with 26% patients stating they would definitely not use such a preparation; patients from Denmark and Sweden were less likely to answer positively, and a positive response was associated with male gender, and previous use of the route. Forty-four percent patients reported regular nasal problems. Sixty percent patients would definitely consider using a subcutaneous product, and 44% patients would definitely consider using an intrapulmonary product.

Fentanyl buccal tablet for breakthrough cancer pain: why titrate?

Breakthrough cancer pain is a significant problem for many patients with cancer because of the fast onset and often unpredictable nature of the pain episodes. The rapid onset opioids therefore have a central role to play in the management of breakthrough cancer pain. The rapid onset opioid fentanyl buccal tablet provides a fast analgesic effect and is easy to administer. However, titration of the medication is essential in order to optimize the management of pain. This is because individual patient characteristics, comorbidities, and other treatments may influence the absorption, pharmacokinetics, and pharmacodynamics of drugs. It is therefore important to individualize treatment by determining the effective dose for each patient, which is the dose that provides adequate analgesia and minimizes undesirable adverse effects. Data from clinical studies of fentanyl buccal tablet show that patients' effective doses ranged from 100 to 800 µg per episode, highlighting the need for the titration process. Following successful dose titration, treatment with fentanyl buccal tablet can achieve significant pain relief as early as 10 minutes after administration, resulting in a high level of patient satisfaction.

Consistent and clinically relevant effects with fentanyl buccal tablet in the treatment of patients receiving maintenance opioid therapy and experiencing cancer-related breakthrough pain.

Fentanyl buccal tablet (FBT) has shown efficacy and tolerability in patients with cancer-related persistent pain treated with maintenance opioids. We conducted a combined analysis of two similarly designed, randomized, placebo-controlled studies to further evaluate the consistency and clinical relevance of analgesia outcomes. Of the 252 patients enrolled, 150 fulfilled the criteria for efficacy analysis and experienced 1,417 breakthrough pain episodes. A consistently greater effect was noted with FBT vs. placebo on the following measures: improvements from baseline of >or=33% and >or=50% in pain intensity (PI), a >or=2-point reduction in PI, and a score of >or=2 for pain relief. Improvements in these clinically meaningful efficacy measures were seen with FBT at 15 minutes (earliest common evaluation) and remained evident at 60 minutes (final common evaluation). They were also reflected in a more favorable global medication performance assessment for FBT over placebo. FBT was generally well tolerated; most adverse events were typical of potent opioid use in a cancer population. Application-site (buccal) abnormalities were infrequent and led to withdrawal of three patients. There were no serious adverse events or deaths attributable to FBT. This analysis suggests that FBT provides an analgesic effect that is consistent across multiple clinically relevant efficacy measures.

Impact and management of breakthrough pain in cancer.

PURPOSE OF REVIEW: To outline the impact of breakthrough pain, the evidence for the current management and new treatment options that are becoming available. RECENT FINDINGS: Breakthrough pain is a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. Despite its self-limiting nature, breakthrough pain can place significant physical, psychological, and economic burdens on both patients and their carers. The successful management breakthrough pain may require a combination of pharmacological and nonpharmacological treatment strategies; supplemental analgesia, known as rescue medication, is a common pharmacological treatment option. The ideal rescue medication should have a rapid onset, good efficacy, relatively short duration of action, and minimal adverse effects and is best administered before or soon after breakthrough pain has started. Although oral opioids are commonly used, there is increasing evidence that transmucosal opioids may be more effective. SUMMARY: Breakthrough is a common heterogeneous pain state that can have a devastating impact on both patients and carers. Despite the growing literature on breakthrough pain, there are still many aspects yet to be addressed including an urgent need to standardize terminology, for carefully designed epidemiological studies and for well designed controlled trials comparing the different treatment options.

Effectiveness of topical administration of opioids in palliative care: a systematic review.

The discovery of peripheral opioid receptors has become the scientific basis for topical use of opioids in malignant and nonmalignant ulcers and oropharyngeal mucositis. This systematic review aimed to assess the quality of published literature and to examine whether topical opioids are effective in controlling pain in palliative care settings. After a systematic literature review, 19 studies (six randomized controlled trials [RCTs] and 13 case reports) met the inclusion criteria for the review. Eighteen studies favored topical opioids in pain relief, as evidenced by reductions in post-treatment pain scores, but time to onset and duration of analgesia varied widely. Because of the heterogeneity of the studies, meta-analysis was not possible. Despite clear clinical benefits described in small RCTs, there is a deficiency of higher-quality evidence on the role of topical opioids, and more robust primary studies are required to inform practice recommendations. N-of-1 trials should be encouraged for specific clinical circumstances.

The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland.

A task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland (APM) was convened to produce some up-to-date, evidence-based, practical, clinical guidelines on the management of cancer-related breakthrough pain in adults. On the basis of a review of the literature, the task group was unable to make recommendations about any individual interventions, but was able to make a series of 12 recommendations about certain generic strategies. However, most of the aforementioned recommendations are based on limited evidence (i.e., case series, expert opinion). The task group also proposed a definition of breakthrough pain, and some diagnostic criteria for breakthrough pain.