Successful buprenorphine transition while overlapping with a full opioid agonist to treat chronic pain: a case report.

Buprenorphine is a partial mu opioid agonist that has been increasingly utilized to treat patients with chronic pain and opioid use disorder (OUD). The drug has proven to provide significant chronic pain relief at low doses ranging from 75 to 1800 mcg. The conventional buprenorphine transitional process delays its introduction until patients begin withdrawal. However, this process can pose a barrier to both patients and providers due to some patients' inability to tolerate traditional prerequisite withdrawal. To our knowledge, this is a rare reported case to describe a transitional process utilizing buccal buprenorphine in which a patient with chronic pain simultaneously tapered completely off an extended-release (ER) full opioid agonist and uptitrated buprenorphine. The patient was weaned from oxycodone ER 30 mg every 12 h and oxycodone/acetaminophen 10/325 mg 3x/day for breakthrough pain utilizing an unconventional approach. Tapering down to oxycodone ER 20 mg 2x/day for the first 2 weeks was successful. However, reducing to oxycodone ER 10 mg 2x/day for the following 2 weeks presented adherence difficulty and increased breakthrough pain. At this time, buccal buprenorphine was added at 300 mcg daily for 3 days. From days 4 to 6, buprenorphine was increased to 300 mcg 2x/day and oxycodone ER decreased to 10 mg daily. Six days later, oxycodone ER was discontinued and oxycodone/acetaminophen continued as needed. The patient exhibited no signs of withdrawal and adequate relief of symptoms through this tapering process. At the 1-month follow-up, the patient was doing well and was being treated solely with buprenorphine and oxycodone/acetaminophen to control her breakthrough pain. After 5 months, buprenorphine was increased to 600 mcg 2x/day and her oxycodone/acetaminophen decreased to 5/325 mg 3x/day as needed. From the start of the patient's taper to her current transition, the patient reduced her morphine milligram equivalent (MME) dosage from 135 MME to 22.5 MME. The Clinical Opioid Withdrawal Scale (COWS), which measures the severity of a patient's opioid withdrawal symptoms, was consistently less than 5. This buprenorphine schedule demonstrated a successful tapering approach for this patient because she had reported improved quality of life and function. A patient-centered osteopathic treatment approach was utilized when the patient presented with mid-taper adherence difficulty. Transitioning patients from full to partial opioid agonists could become an important practice standard for patient safety not only for formal pain management practices but also in primary care, family practice, and even geriatric offices.

Light-Induced Activation of a Specific Type-5 Metabotropic Glutamate Receptor Antagonist in the Ventrobasal Thalamus Causes Analgesia in a Mouse Model of Breakthrough Cancer Pain.

Breakthrough cancer pain (BTcP) refers to a sudden and transient exacerbation of pain, which develops in patients treated with opioid analgesics. Fast-onset analgesia is required for the treatment of BTcP. Light-activated drugs offer a novel potential strategy for the rapid control of pain without the typical adverse effects of systemic analgesic drugs. mGlu5 metabotropic glutamate receptor antagonists display potent analgesic activity, and light-induced activation of one of these compounds (JF-NP-26) in the thalamus was found to induce analgesia in models of inflammatory and neuropathic pain. We used an established mouse model of BTcP based on the injection of cancer cells into the femur, followed, 16 days later, by systemic administration of morphine. BTcP was induced by injection of endothelin-1 (ET-1) into the tumor, 20 min after morphine administration. Mice were implanted with optic fibers delivering light in the visible spectrum (405 nm) in the thalamus or prelimbic cortex to locally activate systemically injected JF-NP-26. Light delivery in the thalamus caused rapid and substantial analgesia, and this effect was specific because light delivery in the prelimbic cortex did not relieve BTcP. This finding lays the groundwork for the use of optopharmacology in the treatment of BTcP.

Characteristics of Breakthrough Pain and Its Impact on Quality of Life in Terminally Ill Cancer Patients.

Purpose. This study aimed to characterize breakthrough pain (BTP) and investigate its impact on quality-of-life (QoL) in terminally-ill cancer patients. Similarities and differences between high and low predictable BTP were also tested. Methods. Secondary analysis of a multicenter longitudinal observational study included 92 patients at their end-of-life. BTP was assessed with a short form of the Italian version of the Alberta Breakthrough Pain Assessment Tool. QoL was assessed with the Palliative Outcome Scale (0-40). Patients were stratified by self-reported BTP predictability into unpredictable BTP (never or rarely able to predict BTP) and predictable BTP (sometimes to always able to predict BTP). Results. In all, 665 BTP episodes were recorded (median 0.86 episodes/day). A median duration of 30 minutes and a median peak intensity score of 7 out of 10 were reported. Time to peak was <10 minutes, 10 to 30 minutes, and ≥30 minutes in 267 (41.1%), 259 (39.9%), and 30 (4.6%) of the episodes, respectively. Onset of relief occurred after a median of 30 minutes. Time to peak (P < .001) and duration (P = .046) of BTP was shorter in patients with predictable pain (n = 31), who usually were younger than those with unpredictable pain (P = .03). The mean (SD) QoL score was 14.6 (4.6). No difference in QoL between patients with predictable and unpredictable BTP was found (P = .49). Conclusions. In terminally-ill cancer patients, BTP is a severe problem with a negative impact on QoL and has different characteristics according to its predictability.

Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy.

PURPOSE: The aim of the current analysis was to evaluate the effectiveness and tolerability of rapid onset opioid in a cohort of head and neck cancer (HNC) patients affected by painful mucositis influencing swallowing function during RT ± ChT with definitive or adjuvant intent. METHODS: A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals. The period of observation has been 90 days starting from the beginning of RT ± ChT. RESULTS: Forty HNC patients with incidental BTP due to painful mucositis treated with FPNS were analyzed. The mean NRS of untreated episodes of BTP was 5.73 ± 1.54 decreasing to 2.25 ± 2.45 with FPNS (median dose 100 mcg). During the pain treatment, the number of meals increased from 2.08 ± 0.35 to 2.868 ± 0.4 (p = 0.000), and the BMI remained stable (from 25.086 ± 3.292 to 25.034 ± 3.090; p = 0.448). The 94.9% of patients was satisfied or very satisfied for the rapidity of the effect, and 97.4% for the easiness and convenience in the use. CONCLUSIONS: FPNS showed an acceptable safety activity profile in predictable BTP due to painful mucositis in HNC patients during RT ± ChT. FPNS was also effective in reducing the mucositis sequelae and allowing the completion of RT scheduled scheme. Moreover, patients declared satisfaction in terms of ease of use.

Fentanyl in a pectin gel treating breakthrough pain in vertebral compression fracture due to multiple myeloma: A descriptive study of three cases.

Breakthrough pain (BTP) currently represents a challenge for health professionals dedicated to the treatment of pain. In this descriptive 1-year follow-up study on three patients with BTP from vertebral crush, in the context of multiple myeloma, the authors have observed the great either efficacy or tolerability profile of fentanyl pectin nasal spray. The most relevant findings in this study were better adherence to treatment compared to previously opioids and also great personal satisfaction. Because of common pathophysiological mechanism for noncancerous pain of bone origin, these good results could open the door to investigation of the use of this drug in this patient's group.

Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study.

CONTEXT: Fentanyl products have shown superiority over oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use an appropriate patient selection, and drugs have been compared using a different rationale. OBJECTIVES: The aim of this randomized, crossover, controlled study was to compare the efficacy and safety of fentanyl pectin nasal spray (FPNS) and oral morphine (OM), given in doses proportional to opioid daily doses. METHODS: Cancer patients with pain receiving ≥60 mg of OM equivalents/day and presenting with ≤3 episodes of BTcP/day were included. Patients received, in a randomized, crossover manner, FPNS or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0), 15 (T15), and 30 minutes (T30) after study drugs. RESULTS: A total of 167 episodes were treated, 82 with FNPS and 85 with OM. A statistical difference in pain intensity between the two groups was observed at T15, but not at T30 (P = 0.018 and P = 0.204, respectively). In a greater number of episodes treated with FPNS, there was a pain decrease of ≥33% in comparison with OM after 15 and 30 minutes (76.5% vs. 32.8%, and 89% vs. 54.9%, respectively). Similar differences were found in the decrease in pain intensity of ≥50% after 15 and 30 minutes (52.3% vs. 11.4%, and 75% vs. 45.8%, respectively). The difference was highly significant at T15 (P < 0.0005). The mean (SD) pain difference at T15 of FPNS and OM were 3.24 (1.7) and 2.70 (1.2), respectively, whereas the mean (SD) SPIDs30 of FPNS and OM were 4.87 (1.7) and 4.54 (1.5), respectively. The difference was highly significant at T15 (P = 0.019). No severe adverse effects after study drug administration were observed. CONCLUSION: When used in doses proportional to the basal opioid regimen, FPNS showed a superior analgesic effect over OM for the management of BTcP. Only minor adverse effects were found with both medications.

Facilitation of accurate and effective radiation therapy using fentanyl pectin nasal spray (FPNS) to reduce incidental breakthrough pain due to procedure positioning.

PURPOSE: To provide effective and accurate radiotherapy (RT) for advanced cancer patients who experience breakthrough pain (BP) due to positioning manoeuvres, through the use of FPNS. Secondary endpoints were the dose and time required to achieve a 50% numeric rating scale (NRS) reduction and conduction of a pharmacoeconomic analysis. PATIENTS AND METHODS: Twenty-seven advanced cancer patients with moderate-severe BP associated with routine radiotherapy procedures and manoeuvres were selected to receive FPNS. Most patients (20/27) had bone metastases. The patients showed a low Karnovsky performance status (mean 54%; range: 30-80). BP intensity was scored with the NRS before and after the procedures that triggered it. All patients were already receiving opioid baseline treatment at a total dose equivalent to 40-160mg oral morphine. Before the procedure, BP was treated with 100-400µg of FPNS. Data related to tolerance, pain relief, onset of the relief and efficient dose to allow RT to proceed were collected. RESULTS: In 26 patients the BP score was reduced by at least 50% as determined in 15.5min (range 8-35min) after fentanyl pectin intranasal administration, and pain relief started after 7min (range 3-15min); p<0.05 in both cases. The duration of pain reduction facilitated the proceeding of RT. The Mean NRS score before the procedure was 9 (95%CI: 8.6-9.4) and decreased during procedure to 3 (95%CI: 2.5-3.8). The average dose of FPNS for most patients was 100-200µg to achieve pain control, except in three patients who required progressive doses of up to 300-400µg. After receiving 300µg, one patient dropped out of the study due to severe adverse effects (nausea). Seven patients reported minor undesirable effects related to FPNS administration. CONCLUSIONS AND IMPLICATIONS: Certain necessary RT procedures in advanced cancer patients can cause severe BP episodes. A simple, safe, fast acting and strong analgesic is needed. FPNS is a rapidly absorbed opioid analgesic with a pain relief profile that would be particularly well suited for this patient population. By reducing BP, the drug enables the completion of necessary RT procedures without needless patient discomfort. When BP is attenuated, Department productivity is maintained and unnecessary delays are avoided. Further studies and clinical trials are needed to assess therapeutic FPNS dosages with a view to defining efficacy in the correct clinical context.

Vías de administración de fentanilo para el tratamiento del dolor irruptivo oncológico / Routes of fentanyl administration for the treatment of breakthrough cancer pain

El dolor irruptivo se define como una exacerbación transitoria de dolor que se produce en un paciente con dolor de base bien controlado. Es muy frecuente entre los pacientes oncológicos. Por las características del dolor irruptivo es necesario que el opioide utilizado en su tratamiento sea potente, de acción rápida, con una duración de efecto corta y fácil de administrar. Por estos motivos, el fármaco ideal para su tratamiento es el fentanilo. En esta revisión se han evaluado 5 formas de administración del fentanilo, sus mecanismos de acción, sus perfiles farmacocinéticos y su eficacia. Se ha realizado una búsqueda utilizando las palabras «dolor irruptivo» y «cáncer» y «fentanilo» y/o «vías de administración». El fentanilo intranasal con pectina (PecFent®) presenta un perfil farmacocinético que se adapta de forma exacta a las características del dolor irruptivo oncológico. La administración intranasal es cómoda y de fácil manejo para el paciente. Se puede utilizar en pacientes que presentan intolerancia a la vía oral. Destaca su capacidad para proporcionar una respuesta analgésica rápida y uniforme episodio a episodio. Por estas razones se puede considerar de elección en pacientes oncológicos que presentan episodios de dolor irruptivo mal controlado

Breakthrough pain is defined as a transitory exacerbation of pain occurring in a patient with well-controlled background pain. This type of pain is highly common in cancer patients. Due to the characteristics of breakthrough pain, the opioid used in its treatment must be potent, fast-acting, with a short effect, and easy to administer. Consequently, the ideal drug for the treatment of breakthrough pain is fentanyl. The present review analyzes 5 routes of fentanyl administration, its mechanisms of action, its pharmacokinetic profiles and its efficacy. A search was made using the words «breakthrough pain», «cancer» and «fentanyl» and/or «routes of administration». The pharmacokinetic profile of fentanyl pectin nasal spray (PecFent®) is perfectly tailored to the characteristics of breakthrough cancer pain. Intranasal administration is convenient and easy for the patient. This drug can be used in patients with intolerance to the oral route. It is able to provide a rapid and uniform analgesic response during repeat administrations. For these reasons, it can be considered the drug of choice in cancer patients with poorly-controlled breakthrough pain

Importancia de la vía nasal para la administración de opioides / Importance of the nasal route in opioid administration

La administración intranasal de opioides es una alternativa eficaz a otras vías de administración, por las excepcionales condiciones de la mucosa nasal para su absorción. Esta vía es óptima para el tratamiento del dolor irruptivo oncológico, que exige un analgésico potente, de inicio rápido, corta duración, fácil administración y pocos efectos adversos. Entre los fentanilos de absorción transmucosa, los intranasales son los que se adaptan mejor al dolor irruptivo oncológico; disponemos de los preparados en solución acuosa y con pectina, rápidos y efectivos. No son intercambiables, solo sustituibles tras una nueva titulación. El fentanilo intranasal con pectina presenta un perfil de acción fiable frente a eventuales pérdidas por goteo posnasal o aclaramiento mucociliar. De aplicación sencilla, cómoda y rápida, y no influenciada por la frecuente xerostomía de los enfermos con cáncer avanzado, ni la posible mucositis oral, ni rinitis. No es dependiente de las habilidades del enfermo para su administración. No genera efectos adversos relevantes, sistémicos o locales. Con inicio de la analgesia a los 5 min de su aplicación, buena tolerabilidad y aceptación por parte de los pacientes. Efectivo, no suele precisar de correcciones en la dosificación tras la titulación, incluso a largo plazo. Esta revisión recuerda las características de la vía intranasal junto al uso de distintos opioides, particularizando la atención en el fentanilo intranasal con pectina

Intranasal (IN) opioid administration is a highly effective alternative to other routes of administration due to the exceptional conditions of the nasal mucosa for opioid absorption. This route is ideal for fentanyl administration for the treatment of breakthrough cancer pain, which requires an analgesic that is potent, with rapid onset, short duration, easy administration and few adverse effects. Among transmucosal fentanyl preparations, the best adapted to breakthrough cancer pain are IN preparations. These rapid and effective preparations are available in aqueous solution and in pectin. They are not interchangeable and can only be substituted after a new titration. Fentanyl pectin nasal spray has a reliable profile of action against eventual losses due to postnasal drip or mucociliary clearance. The preparation is simply and easy to administer with rapid onset and is not affected by the dry mouth that is common in advanced cancer patients, or possible oral mucositis or rhinitis. Administration does not depend on the patient's skill. This drug has no relevant systemic or local adverse effects. Onset of analgesia occurs 5 minutes after application and the drug is well tolerated and accepted by patients. Dose adjustments are not normally required after titration, even in the long-term. This review describes the characteristics of the IN route, together with the use of distinct opioids, with particular emphasis on fentanyl pectin nasal spray

Manejo de opioides para el dolor basal e irruptivo oncológico / Opioid management for background and breakthrough cancer pain

El dolor relacionado con cáncer es experimentado por el 90% de los pacientes oncológicos. La base del tratamiento son los opioides y la escalera analgésica, de la Organización Mundial de la Salud. El dolor irruptivo oncológico es una forma de dolor relacionado con el cáncer particularmente difícil de gestionar con los opioides clásicos. En esta revisión se cubre la titulación y la rotación de opioides, tanto para dolor basal como irruptivo. También se revisa la contribución de los preparados de fentanilo de acción rápida para el tratamiento del dolor irruptivo oncológico, su indicación y titulación. El citrato de fentanilo oral transmucoso y los comprimidos bucales de fentanilo fueron los primeros fármacos desarrollados específicamente para el tratamiento del dolor irruptivo oncológico. Dado que la administración oral de fentanilo no es una opción en muchos pacientes oncológicos, el desarrollo de un espray intranasal de fentanilo con pectina surgió como un método más eficaz de administración

Cancer-related pain is experienced by 90% of patients with cancer. The mainstays of treatment are opioids and the World Health Organization's analgesic ladder. Breakthrough cancer pain (BCP) is a form of cancer-related pain that is particularly difficult to manage with classical opioids. In this review, we discuss titration and opioid rotation in both background and breakthrough pain. We also review the contribution of fast-acting fentanyl preparations for the treatment of BCP and its indications and dose titration. The first drugs developed specifically for the treatment of BCP were oral transmucosal fentanyl citrate (CFOT) and fentanyl buccal tablets. Because oral fentanyl administration is not an option in many cancer patients, the development of a fentanyl nasal spray (FNS) has emerged as a more effective method of administration

Investigación clínica del fentanilo intranasal con pectina / Clinical research in fentanyl pectin nasal spray

A pesar del tratamiento adecuado del dolor basal crónico con opioides mayores, determinados pacientes sufren exacerbaciones transitorias e intensas de inicio rápido, corta duración y gran intensidad denominadas dolor irruptivo. Este tipo de dolor requiere un tratamiento específico con analgésicos capaces de mimetizar las características del episodio de dolor irruptivo. Entre esos analgésicos destaca la formulación de fentanilo de absorción transmucosa nasal a base de pectina (PecFent®), cuyo desarrollo clínico se resume brevemente en este artículo

Despite adequate control of chronic cancer pain with major opioids, some patients experience transitory and intense exacerbations. These exacerbations, known as breakthrough pain, are characterized by rapid onset, short duration and strong intensity. Episodes of breakthrough pain require specific treatment with analgesics tailored to relieve this type of pain. Notable among these analgesics is a transmucosal nasal fentanyl formulation in a pectin-based gel (PecFent®), whose clinical development is summarized in this article

Casos clínicos de eficacia y seguridad del fentanilo intranasal con pectina en Oncología Médica / Efficacy and safety of fentanyl pectin nasal spray in Medical Oncology: clinical cases

El dolor oncológico es un problema complejo y de gran importancia en la práctica clínica diaria. Aunque el cáncer suele ser indoloro en las primeras fases de su desarrollo, la prevalencia de dolor crónico maligno es del 30-50% en pacientes oncológicos que están en tratamiento activo y del 70-90% en los pacientes con enfermedad avanzada. La prevalencia real del dolor irruptivo oncológico no está clara y es muy variable en función de los estudios, con un abanico que abarca del 19 al 93%. La disnea es un síntoma muy frecuente y común a muchas enfermedades, lo que traduce su origen multisistémico, y se puede presentar tanto en patología respiratoria como en enfermedades no respiratorias. Está presente hasta en el 78% de los pacientes con cáncer de pulmón. Se presentan 2 casos clínicos en los que se utilizó fentanilo intranasal con pectina, tanto para el manejo del dolor irruptivo oncológico como para las crisis de disnea, obteniendo en ambos casos un gran alivio sintomático

Cancer pain is a complex and highly important problem in daily clinical practice. Although cancer is usually painless in the early phases of its development, the prevalence of chronic pain is 30%-50% in cancer patients undergoing active treatment and 79%-90% in patients with advanced disease. The true prevalence of breakthrough cancer pain is unclear and varies widely across studies, ranging from 19% to 93%. Dyspnea is a highly frequent symptom that is common to many diseases, indicating its multisystemic origin. This symptom can occur in respiratory and non-respiratory diseases. Dyspnea is present in up to 78% of patients with lung cancer. We describe two clinical cases in which fentanyl pectin nasal spray was used in the management of both breakthrough cancer pain and dyspnea exacerbations, providing strong symptomatic relief in both patients

Fentanyl pectin nasal spray as treatment for incident predictable breakthrough pain (BTP) in oral mucositis induced by chemoradiotherapy in head and neck cancer.

BACKGROUND: Painful mucositis is one of the most distressing toxicities of chemoradiotherapy (CRT) for head and neck cancer (HNC), with the characteristics of incidental predictable breakthrough pain (BTP) during swallowing. Fentanyl pectin nasal spray (FPNS) could be a good therapeutic option. METHODS: Patients were prospectively considered if receiving basal analgesic therapy with opiates for painful mucositis of grade ⩾4 on a numerical rating scale from 0 to 10. They were offered FPNS 100mcg before oral intake. When patients reached the effective dose, they evaluated the basal pain intensity before FPNS use and after 10, 20, 30 and 40min. RESULTS: Seventeen HNC patients were offered FPNS before oral intake, with 15 patients completing treatment. Mean reduction of incidental BTP intensity after FPNS was 3.1 points (range 1.2-5.8). Mean time elapsed since FPNS use and highest pain reduction was 26min. CONCLUSIONS: FPNS demonstrated activity against BTP when swallowing in HNC patients. These data should be considered as hypothesis-generating.

Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain.

OBJECTIVE: Evaluate aberrant drug-related behaviors in patients administering fentanyl buccal tablet or traditional short-acting opioids for breakthrough pain. DESIGN: Twelve-week open-label extension. SETTING: Forty-two US sites. SUBJECTS: Opioid-tolerant patients with chronic pain who completed the previous randomized, double-blind, crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain. METHODS: Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin any traditional short-acting opioid. Assessments included Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) at baseline and Addiction Behaviors Checklist and Current Opioid Misuse Measure at baseline and final visit. Case report forms were reviewed retrospectively to identify aberrant drug-related behaviors. RESULTS: One hundred thirty patients entered the open-label extension (fentanyl buccal tablet, N = 65; traditional short-acting opioid, N = 65). SOAPP-R scores were <18 (low risk of aberrant drug-related behavior) in 74% of patients; no significant differences in SOAPP-R scores were observed between treatment groups. At the final visit, ≤14% of patients in each treatment group had scores indicating potential aberrant drug-related behavior (Addiction Behaviors Checklist ≥3, Current Opioid Misuse Measure ≥9); no significant differences in scores were observed between treatment groups. Baseline SOAPP-R score ≥18 was not predictive of Addiction Behaviors Checklist ≥3 but was predictive of Current Opioid Misuse Measure ≥9. Aberrant behaviors were identified in 12 (18%) fentanyl buccal tablet patients and 13 (20%) traditional short-acting opioid patients. CONCLUSIONS: Incidence of aberrant drug-related behaviors was similar between patients taking fentanyl buccal tablet and traditional short-acting opioids over 12 weeks.

Intranasal fentanyl versus fentanyl pectin nasal spray for the management of breakthrough cancer pain in doses proportional to basal opioid regimen.

UNLABELLED: The aim of this randomized, crossover, comparison study was to assess the analgesic and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid basal regimen. Each patient randomly received INFS or FPNS in doses proportional to opioid dosages used for background analgesia for 2 pairs of episodes. For each episode of breakthrough pain, pain intensity and adverse effects intensity were recorded just before starting the INFS or FPNS (T0) and 5 minutes (T5), 10 minutes (T10), and 20 minutes (T20) after the administration of the nasal drugs. Sixty-nine patients were studied. The mean age was 63.4 years, and 37 patients were males. For the present analysis, 188 episodes were considered. A statistical decrease in pain intensity was observed with both nasal drugs after 5, 10, and 20 minutes. A decrease in pain intensity of >33% was observed in 16, 102, and 159 treated episodes at T5, T10, and T20, respectively. Adverse effects were of mild nature in most cases or were preexistent because of basal opioid therapy. No differences were found in summed pain intensity difference 20 minutes after dosing. Most of patients did not find substantial preferences. INFS and FPNS were effective and well-tolerated treatments for breakthrough pain management. Both delivery systems, in doses proportional to the basal opioid regimen, provided significant analgesia within 10 minutes, without producing relevant adverse effects. PERSPECTIVE: This article showed that INFS and FPNS in doses proportional to basal opioid regimen are equally safe and effective for the management of breakthrough pain in cancer patients. These data provide new insights on the use of nasal preparations of fentanyl.

A report on the long-term use of fentanyl pectin nasal spray in patients with recurrent breakthrough pain.

CONTEXT: As patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. OBJECTIVES: To investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy. METHODS: Adult patients (N = 401) taking at least 60 mg/day oral morphine or equivalent, experiencing one to four episodes of BTPc a day, entered an open-label long-term study (NCT00458510). Patients had either completed an FPNS randomized controlled trial or were newly identified. Of these, 171 patients continued into an extension study. Up to four episodes of BTPc a day were treated with FPNS at 100-800 µg titrated doses. During the extension study, patients visited the clinic every four weeks for assessment and reporting of adverse events (AEs). RESULTS: There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for ≥360 days; the maximum duration was 44 months. Seventy percent of patients did not change their FPNS dose; 2% of patients withdrew from the study because of the lack of efficacy. The most common AEs, aside from disease progression, were insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of FPNS-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced nasal AEs, most of which were mild or moderate. CONCLUSION: FPNS appeared to provide sustained benefit and was well tolerated during long-term treatment of BTPc.

Cancer pain management in an oncological ward in a comprehensive cancer center with an established palliative care unit.

BACKGROUND: This survey was performed to draw information on pain prevalence, intensity, and management from a sample of patients who were admitted to an oncologic center where a palliative care unit (PCU) has been established for 13 years. METHODS: Cross-sectional survey in an oncological department performed 1 day per month for six consecutive months. RESULTS: Of the 385 patients, 69.1, 19.2, 8.6, and 3.1 % had no pain, mild, moderate, and severe pain, respectively. Inpatients and patients with a low Karnofsky score showed higher levels of pain intensity (p < 0.0005). One hundred twenty-eight patients with pain or receiving analgesics were analyzed for pain management index (PMI). Only a minority of patients had negative PMI score, which was statistically associated with inpatient admission (p = 0.011). Fifty of these 128 patients had breakthrough pain (BTP), and all of them were receiving some medication for BTP. CONCLUSION: It is likely that the presence of PCU team providing consultation, advices, and cultural pressure, other than offering admissions for difficult cases had a positive impact on the use of analgesics, as compared with previous similar surveys performed in oncological setting, where a PCU was unavailable. This information confirms the need of the presence of a PCU in a high volume oncological department.