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AbstractObjective:The efficacy of intranasal fentanyl spray (INFS) was compared with that of oral transmucosal fentanyl citrate (OTFC) for the relief of cancer-related breakthrough pain (BTP) in an open-label, crossover trial.Methods:Adult cancer patients receiving stable background opioid treatment and experiencing BTP episodes were recruited from 44 study centres in seven European countries (Austria, France, Germany, Italy, Poland, Spain and the United Kingdom); of the 196 patients enrolled, 139 were randomised to receive INFS followed by OTFC, or vice versa. Patients were titrated to an effective dose of one agent (50, 100 or 200 µg INFS; 200, 400, 600, 800, 1200 or 1600 µg OTFC) to treat six BTP episodes, then titration and treatment were repeated with the other agent. The primary outcome was patient-recorded time to onset of ‘meaningful’ pain relief. Secondary outcomes included pain intensity difference (PID) at 10 and 30 minutes (PID10, PID30), sum of PID at 15 and 60 minutes (SPID0–15, SPID0–60), ease of administration, treatment preference and relationship between background opioid dose and effective INFS dose. Additional outcome measures included proportions of episodes with ≥33 and ≥50 pain intensity (PI) reduction, and PID at additional time points.Clinical trial registration number:NCT00496392.Results:Among the intention-to-treat population (n  139), median time to onset of ‘meaningful’ pain relief was 11 minutes with INFS versus 16 minutes with OTFC; 65.7 of patients attained faster time to ‘meaningful’ pain-relief onset with INFS (p < 0.001). PID was statistically significantly greater for INFS than OTFC from 5 minutes post-dosing. Significantly more INFS-treated breakthrough pain episodes achieved clinically important pain relief (≥33 and ≥50 PI reduction) up to 30 minutes post-dosing. The proportions of episodes treated with INFS and OTFC achieving a PI reduction of ≥33 at 5 minutes were 25.3 versus 6.8 (p < 0.001), and at 10 minutes were 51.0 versus 23.6 (p < 0.001), respectively; the proportions of episodes treated with INFS and OTFC achieving a ≥50 PI reduction at 5 minutes were 12.8 versus 2.1 (p < 0.001), and at 10 minutes were 36.9 versus 9.7 (p < 0.001), respectively. Higher SPID0–15and SPID0–60scores were achieved with INFS (p < 0.001). More patients preferred INFS than OTFC (p < 0.001) and more patients found it very easy/easy to use. Both treatments were well tolerated. In the safety population (n  139), 56.8 (n  79) of patients experienced ≥1 AE during the trial. The only AE that occurred in ≥5 of patients in either treatment group was nausea. Among those patients who experienced serious AEs (13.7, n  19), none were considered to be related to either study medication. There was a weak correlation between effective INFS doses and background opioid doses.Conclusion:In this open-label, randomised, crossover trial, significantly more patients attained faster ‘meaningful’ pain relief with INFS than OTFC, and more patients preferred INFS to OTFC. [ABSTRACT FROM AUTHOR]

Resumen Contexto: La Academia Pontificia de la Vida (PAV) es una institución académica de la Santa Sede (Vaticano) cuyo objetivo es promover una visión católica de la ética biomédica. La PAV invitó a una serie de expertos en Cuidados Paliativos (CP) de todo el mundo, de todas las creencias, a desarrollar recomendaciones estratégicas para el desarrollo global de CP ("Grupo PAL-LIFE"). Diseño: Trece expertos internacionales reconocidos por su actividad promotora global de CP participaron en un estudio Delphi on-line. En un proceso de cuatro rondas, se pidió a los participantes que identificasen los grupos de interés o instituciones claves para la promoción de CP y que propusieran, para cada uno de ellos, recomendaciones estratégicas para el desarrollo de CP. Cada ronda incorporaba los comentarios de las rondas previas hasta lograr el consenso en las recomendaciones más importantes. En una última fase, al grupo de expertos se le solicitó la jerarquización por importancia de los grupos clave en una escala de 1 a 13. También se solicitaron sugerencias concretas para la implementación de las recomendaciones. Mediante análisis clúster se ordenaron los grupos de interés en dos niveles de importancia para el desarrollo de CP. Resultados: Trece recomendaciones fueron seleccionadas como las más importantes (una por cada grupo clave). Las recomendaciones para los grupos mejor puntuados fueron: (1) Responsables Políticos: garantizar el acceso universal a los CP; (2) Academia: ofrecer cursos obligatorios de CP en el pregrado; (3) Profesionales sanitarios: promover una certificación adecuada; (4) Hospitales e Instituciones sanitarias: asegurar el acceso a medicamentos de CP; y (5) Asociaciones de CP: ser promotoras eficaces y trabajar con los gobiernos en la implementación de las recomendaciones internacionales sobre CP. También se presentan recomendaciones para los ocho grupos clave restantes. Discusión: Este documento representa la posición oficial de la PAV en lo que respecta a estrategias de promoción para el desarrollo de los CP en el mundo.

Background: The Pontifical Academy for Life (PAV) is an academic institution of the Holy See (Vatican), which aims to develop and promote Catholic teachings on questions of biomedical ethics. Palliative care (PC) experts from around the world professing different faiths were invited by the PAV to develop strategic recommendations for the global development of PC ("PAL-LIFE group")., Design: Thirteen experts in PC advocacy participated in an online Delphi process. In four iterative rounds, participants were asked to identify the most significant stakeholder groups and then propose for each, strategic recommendations to advance PC. Each round incorporated the feedback from previous rounds until consensus was achieved on the most important recommendations. In a last step, the ad hoc group was asked to rank the stakeholders' groups by order of importance on a 13-point scale and to propose suggestions for implementation. A cluster analysis provided a classification of the stakeholders in different levels of importance for PC development., Results: Thirteen stakeholder groups and 43 recommendations resulted from the first round, and, of those, 13 recommendations were chosen as the most important (1 for each stakeholder group). Five groups had higher scores. The recommendation chosen for these top 5 groups were as follows: (1) Policy makers: Ensure universal access to PC; (2) Academia: Offer mandatory PC courses to undergraduates; (3) Healthcare workers: PC professionals should receive adequate certification; (4) Hospitals and healthcare centers: Every healthcare center should ensure access to PC medicines; and (5) PC associations: National Associations should be effective advocates and work with their governments in the process of implementing international policy framework. A recommendation for each of the remaining eight groups is also presented., Discussion: This white paper represents a position statement of the PAV developed through a consensus process in regard to advocacy strategies for the advancement of PC in the world.

Context: We recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose., Objectives: To report the consistency of efficacy, tolerability, and patient acceptability of FPNS vs. IRMS., Methods: Patients (n=110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Those who completed an open-label titration phase (n=84) continued to a DB/DD phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). Pain intensity (PI) and pain relief scores were assessed. Patient acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments., Results: Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful pain relief (P<0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P<0.01) and 60 (P<0.05) minutes. Patients were "satisfied/very satisfied" with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of patients withdrew from titration because of AEs; no significant nasal effects were reported., Conclusion: This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP., (Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Objective: to assess the long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer pain (BTCP)., Design: a multicenter, open-label study., Patients: patients with chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent experiencing 1-4 episodes per day of BTCP., Intervention: all patients entered into a 16-week treatment phase after undergoing a dose-titration phase with FPNS., Main Outcome Measures: safety and tolerability were assessed by adverse events (AEs) and by nasal tolerability assessments. Consistency of effect was monitored through additional rescue medication use and FPNS dose change., Results: four hundred three patients were included in the safety analyses. Of these, 356 patients entered the treatment phase and 110 patients completed the study. FPNS was self-administered for 42,227 episodes. During the treatment phase, 99 patients (24.6 percent) reported treatment-related AEs; most were mild or moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 percent), but only five were considered related to study drug. Of the 80 deaths that occurred during this study, one was assessed as possibly related to study drug. Nasal assessments revealed no significant local effects. No additional rescue medication was required after 94 percent of FPNS-treated episodes. More than 90 percent of patients required no increase in their initial dose of FPNS., Conclusions: FPNS use for BTCP was associated with AEs, typical of opioids, with no evidence of nasal toxicity. A large proportion of BTCP episodes were treated with a single dose, and doses remained stable over the 4-month period.

The European Association for Palliative Care (EAPC) considers sedation to be an important and necessary therapy option in the care of selected palliative care patients with otherwise refractory distress. Prudent application of this approach requires due caution and good clinical practice. Inattention to potential risks and problematic practices can lead to harmful and unethical practice which may undermine the credibility and reputation of the responsible clinicians and institutions as well as the discipline of palliative medicine more generally. Procedural guidelines are helpful to educate medical providers, set standards for best practice, promote optimal care and convey the important message to staff, patients and families that palliative sedation is an accepted, ethical practice when used in appropriate situations. EAPC aims to facilitate the development of such guidelines by presenting a 10-point framework that is based on the pre-existing guidelines and literature and extensive peer review.

Severe dyspnoea is the most threatening symptom of the dying and one of the main reasons for undesirable hospitalisation in end of life. Especially in home care there is a need for a noninvasive, safe and highly effective method for symptom control. Fentanyl is an appropriate drug because of its fast onset and short duration of action. Since 2003 medicated the Palliative Net Easthessia (PNO) more than 600 home care patients with nasal Fentanyl (naF). The method is simple and the user should bear in mind that the substance is highly effective. Both physician and pharmacist should inform themselves adequately before the first use about the basics of the manufacturing and use. Two typical case reports will be shown. Clinical experience let us assume that intranasal administration against dyspnoea is not inferior to the intravenous symptom control. In ambulant care caused by the use of the caring relatives or the patients themselves non-invasivity is a great advantage. Prospective studies are in need to prove the method.

Objective: The efficacy of intranasal fentanyl spray (INFS) was compared with that of oral transmucosal fentanyl citrate (OTFC) for the relief of cancer-related breakthrough pain (BTP) in an open-label, crossover trial., Methods: Adult cancer patients receiving stable background opioid treatment and experiencing BTP episodes were recruited from 44 study centres in seven European countries (Austria, France, Germany, Italy, Poland, Spain and the United Kingdom); of the 196 patients enrolled, 139 were randomised to receive INFS followed by OTFC, or vice versa. Patients were titrated to an effective dose of one agent (50, 100 or 200 microg INFS; 200, 400, 600, 800, 1200 or 1600 microg OTFC) to treat six BTP episodes, then titration and treatment were repeated with the other agent. The primary outcome was patient-recorded time to onset of 'meaningful' pain relief. Secondary outcomes included pain intensity difference (PID) at 10 and 30 minutes (PID(10), PID(30)), sum of PID at 15 and 60 minutes (SPID(0-15), SPID(0-60)), ease of administration, treatment preference and relationship between background opioid dose and effective INFS dose. Additional outcome measures included proportions of episodes with > or =33% and > or =50% pain intensity (PI) reduction, and PID at additional time points., Clinical Trial Registration Number: NCT00496392., Results: Among the intention-to-treat population (n = 139), median time to onset of 'meaningful' pain relief was 11 minutes with INFS versus 16 minutes with OTFC; 65.7% of patients attained faster time to 'meaningful' pain-relief onset with INFS (p < 0.001). PID was statistically significantly greater for INFS than OTFC from 5 minutes post-dosing. Significantly more INFS-treated breakthrough pain episodes achieved clinically important pain relief (> or =33% and > or =50% PI reduction) up to 30 minutes post-dosing. The proportions of episodes treated with INFS and OTFC achieving a PI reduction of > or =33% at 5 minutes were 25.3% versus 6.8% (p < 0.001), and at 10 minutes were 51.0% versus 23.6% (p < 0.001), respectively; the proportions of episodes treated with INFS and OTFC achieving a > or =50% PI reduction at 5 minutes were 12.8% versus 2.1% (p < 0.001), and at 10 minutes were 36.9% versus 9.7% (p < 0.001), respectively. Higher SPID(0-15) and SPID(0-60) scores were achieved with INFS (p < 0.001). More patients preferred INFS than OTFC (p < 0.001) and more patients found it very easy/easy to use. Both treatments were well tolerated. In the safety population (n = 139), 56.8% (n = 79) of patients experienced > or =1 AE during the trial. The only AE that occurred in > or =5% of patients in either treatment group was nausea. Among those patients who experienced serious AEs (13.7%, n = 19), none were considered to be related to either study medication. There was a weak correlation between effective INFS doses and background opioid doses., Conclusion: In this open-label, randomised, crossover trial, significantly more patients attained faster 'meaningful' pain relief with INFS than OTFC, and more patients preferred INFS to OTFC.

The tragic death of a 26-year old hobby soccer player is described, who had a collision with the opposing goalie and suffered from a fracture of the left lateral process of the atlas, an extensive subarachnoid haemorrhage, tamponade of the third and fourth cerebral ventricles, bleeding into both lateral cerebral ventricles, infratentorial and supratentorial cerebral oedema. Furthermore, a survey of the literature concerning acute death in soccer is presented.