Retrospective Observational Study on the Characteristics of Pain and Associated Factors of Breakthrough Pain in Advanced Cancer Patients.

Objective: This study aimed to conduct a retrospective observational study to understand the status of characteristics of pain and identify potential variables influencing the clinical presentation of breakthrough cancer pain (BTP) in advanced cancer patients. Methods: Advanced cancer patients over 18 years of age; diagnosed with cancer of any type and stage III or IV in the palliative care ward with available data were enrolled between 2018 and 2020. Demographic data and pain-related information were collected by using structured electronic extraction form from Hospital Information System (HIS). Patients who had well-controlled background pain with an intensity ≤4 on a 0-10 numerical scale for >12 hours/day, the presence of transient exacerbations of pain with moderate-severe intensity (≧5), and clearly distinguish from background pain were regarded to have suffered BTP. Spearman correlation was conducted to explore the relationship between pain score and demographics characteristics. Factors significant in univariate analysis were included in the multiple regression model to explore independent predictive factors associated with the BTP. Results: Of 798 advanced cancer patients, the mean age was 56.7 (SD = 11.84) years. Lung cancer (29.95%) was the most common cancer, and pain (93%) was the most common symptom. More than half (n = 428, 53.6%) of the patients experienced BTP. The median number of BTP episodes was 4 (IQR = 2, 7, range: 1-42). The median intensity of BTP was 6 (IQR = 6, 7, range 5-10). Patients with severe background pain or BTP had longer hospital stay and more symptoms. Besides, more severe background pain was related to higher activity of daily living. Intramuscular injection of hydromorphone hydrochloride was the main medication for BTP onset. Younger age, background pain, anorexia, and constipation were independently associated with the presentation of BTP. BTP pain intensity was independently associated with bloating. Symptom numbers were an independent factor and positively associated with BTP episodes. Conclusions: BTP resulted in poor prognosis, which has a variable presentation depending on interdependent relationships among different characteristics. Good controlling of background pain and assessment of pain-related symptoms are essential for BTP management. BTP should be managed individually, especially the invisible pain among aged patients. Furthermore, BTP-related education and training were still needed.

Prevalencia y caracterización del dolor irruptivo oncológico en pacientes hospitalizados en Vigo. Estudio Dolopaho / Prevalence and characterization of breakthough cancer pain in hospitalized patients in Vigo. The Dolopaho study

Introducción: El dolor sigue siendo en la actualidad un problema no resuelto en los pacientes con cáncer. A pesar de los avances en el tratamiento del dolor en los últimos años, persisten lagunas que dificultan un tratamiento global, como es el caso del dolor irruptivo oncológico (DIO). Objetivos: Evaluar la prevalencia de DIO de una muestra de pacientes ingresados en un servicio de oncología médica, analizar si el dolor era el principal motivo de ingreso en estos pacientes, así como determinar si existe un infradiagnóstico y, por tanto, un infratratamiento en los mismos previamente al ingreso. Métodos: Estudio observacional prospectivo. Se reclutaron los pacientes de forma consecutiva, independientemente del motivo de ingreso. Las variables analizadas en relación con el dolor irruptivo fueron las siguientes: presencia de dolor irruptivo según el algoritmo de Davies; semejanza de los episodios de dolor irruptivo entre sí y respecto al dolor basal; número de crisis de dolor a lo largo del día y a lo largo de la semana; escala visual analógica del dolor irruptivo; tiempo desde el inicio del dolor hasta su máxima intensidad medida en los siguientes rangos: < 5 min, 5-30 min, > 30 min; la duración de los episodios: < 5 min, 5-30 min, > 30 min; desencadenantes del dolor irruptivo (incidental, espontáneo); percepción individual de la alteración en la calidad de vida y efectividad de los fármacos utilizados. Resultados: Se incluyeron un total de 115 pacientes. En la muestra analizada el 33,9 % de los pacientes presentaron dolor irruptivo, de ellos el 95 % recibían tratamiento con opioides mayores, pero en solo el 56 % de los casos se asociaron a opioides de liberación ultrarrápida. Conclusión: El manejo de los pacientes con DIO continúa siendo un reto a día de hoy. Cerca de la mitad de los pacientes con dolor irruptivo no habían recibido tratamiento adecuado en nuestro estudio y, por tanto, probablemente no estaban bien caracterizados. (AU)

Background: Pain is often inadequately treated in patients with cancer. Although in recent years there have been major advances in the treatment of pain, there are still gaps for a global treatment, such as breakthrouth cancer pain (BCP). Objectives: The main objective was to evaluate the prevalence of BCP in a sample of patients admitted to a oncology medical department, in order to see whether pain is the main reason for admission in these patients, as well as to determine whether they were correctly treated and diagnosed before admission. Methods: An observational, prospective study. Patients were enrolled consecutively, regardless of reason for admission. The variables analyzed in relation to breakthrough pain were the following: presence of breakthrough pain according to the Davies scale; similarities of breakthrough pain events to each other and to baseline pain; number of irruptive pain events throughout the day and throughout the week; visual analogue scale of breakthrough pain; time between the onset of breakthrough pain and maximum intensity as measured in the following ranges: < 5 minutes, 5-30 minutes, > 30 minutes; duration of the breakthrough pain event (< 5 minutes, 5-30 minutes, > 30 minutes); triggers of breakthrough pain (incidental, spontaneous); perceived quality of life impairment and effectiveness of the drugs used. Results: A total of 115 patients consecutively admitted were analyzed regardless of reason for admission. In the analyzed sample, 33.9 % of patients had breakthrouth pain, and 95 % of the patients with breakthrough pain received treatment with strong opioids, though only in 56.4 % of cases associated with ultra-rapid-release opioids.Conclusions: The management of BCP is still a challenge. About half of patients with breakthrough cancer pain had not received adecuated treatment in our study, and were therefore poorly diagnosed. (AU)

Quality of life in patients with breakthrough cancer pain in radiation oncology departments in Spain: the CAVIDIOR study.

Aim: The CAVIDIOR study evaluated quality of life (QoL) in patients with breakthrough cancer pain receiving palliative radiation therapy in radiation oncology departments (RODs) in Spain. Patients & methods: Prospective observational study at 11 Spanish RODs (July 2016-November 2017). QoL was assessed using Short Form Health Survey 12. Secondary end points were sleep quality, caregiver burden and patient/perception of improvement. Results: QoL improved according to the Short Form Health Survey 12 mental component. Sleep quality and caregivers' burden improved significantly. Conclusion: Breakthrough cancer pain is highly prevalent and can be substantially reduced with appropriate diagnosis and management in RODs. Along with the QoL questionnaire, sleep quality and caregiver burden provide a more comprehensive assessment of overall health status in patients receiving radiation therapy in RODs. Clinical trial registration: NCT02836379 (ClinicalTrials.gov).

Episodic Cancer Pain: Patient Reporting, Prevalence, and Clinicodemographic Associations at Initial Cancer Pain Clinic Assessment.

Background: Better understanding of the episodic cancer pain (CP) spectrum, including pains that occur in addition to its conventionally defined breakthrough CP (BTcP) and incident CP (IcP) components, may inform CP assessment and management. This study aimed to determine the prevalence of episodic patient-reported CP and the prevalence and associations of study-defined BTcP (S-BTcP) and IcP (S-IcP) in patients with CP. Methods: In a cross-sectional study at their first CP clinic attendance, participants with CP had the following assessments: Brief Pain Inventory (BPI); Pain Management Index (PMI), with PMI-negative status indicating undertreatment; standardized neuropathic pain component (NPC) status; S-BTcP (no trigger identified) and S-IcP (trigger identified) status, based on a preceding 7-day history of transitory pain flares distinct from background pain, and BPI-Worst or BPI-Now pain intensity ≥ 4. Clinicodemographic variables' association with S-BTcP and S-IcP was examined in logistic regression analyses. Results: Of 371 participants, 308 (83%) had episodic CP by history alone; 140 (37.7%) and 181 (48.8%) had S-BTcP and S-IcP, respectively. Multivariable analyses demonstrated significant (p < 0.05) associations (odds ratios: 95% CIs) for 6 variables with S-BTcP: head and neck pain location (2.53; 1.20-5.37), NPC (2.39; 1.34-4.26), BPI average pain (1.64; 1.36-1.99), abdominal pain (0.324; 0.120-0.873), S-IcP (0.207; 0.116-0.369), and PMI-negative status (0.443; 0.213-0.918). Similar independent associations (p < 0.05) occurred for S-IcP with NPC, BPI average pain, and PMI-negative status, in addition to radiotherapy, S-BTcP, soft tissue pain, and sleep interference. Conclusions: Episodic or transient patient-reported CP flares often do not meet the more conventional criteria that define BTcP and IcP, the principal episodic CP types. Both BTcP and IcP occur frequently and both are associated with a NPC, higher pain intensity, and less opioid underuse in the management of CP. Further studies are warranted to both better understand the complex presentations of episodic CP and inform its classification.

Prevalence and characterization of breakthrough pain in patients with cancer in Spain: the CARPE-DIO study.

We aimed to evaluate the prevalence, characteristics and impact of breakthrough pain (BTP) in patients with cancer attending the main specialties involved in the diagnosis and management of BTP in Spain using a multicenter, observational, cross-sectional, multidisciplinary study. Investigators had to record all patients seen at the clinic during 1 month, determine whether the patients had cancer pain, and apply the Davies algorithm to ascertain whether the patients were suffering from BTP. Of the 3,765 patients with cancer, 1,117 (30%) had cancer-related pain, and of these patients, 539 had BTP (48%, 95%CI:45-51). The highest prevalence was found in patients from palliative care (61%, 95%CI:54-68), and the lowest was found in those from hematology (25%, 95%CI:20-31). Prevalence varied also according to sex and type of tumor. According to the Alberta Breakthrough Pain Assessment Tool duration, timing, frequency, location, severity, quality, causes, and predictability of the BTP varied greatly among these patients. BTP was moderate (Brief Pain Inventory [BPI]-severity median score = 5.3), and pain interference was moderate (BPI-interference median score = 6.1) with a greater interference with normal work, general activity, and enjoyment of life. Patients with BTP showed a mean ± standard deviation score of 28.5 ± 8.0 and 36.9 ± 9.5 in the physical and mental component, respectively, of the SF-12 questionnaire. In conclusion, prevalence of BTP among patients exhibiting cancer-related pain is high. Clinical presentation is heterogeneous, and therefore, BTP cannot be considered as a single entity. However, uniformly BTP has an important impact on a patient's functionality, which supports the need for early detection and treatment.

Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial.

BACKGROUND: Programmed intermittent epidural bolus (PIEB) techniques are a new area of interest for maintaining labor analgesia due to the potential to decrease motor block and improve labor analgesia. This study compares continuous epidural infusion (CEI) to 2 PIEB regimens for labor analgesia. METHODS: One hundred fifty patients undergoing scheduled induction of labor at term gestation having epidural labor analgesia were randomized to receive an epidural analgesia regimen of bupivacaine 0.125% with fentanyl 2 µg/ml at either PIEB 5 ml every 30 min (Group 5q30), PIEB 10 ml every 60 min (Group 10q60), or 10 ml/h continuous infusion (Group continuous epidural infusion [CEI]). The primary outcome is the pain scores throughout labor. Secondary outcomes include degree of motor block, dermatomal sensory levels, the number of physician-administered boluses, and patient satisfaction. RESULTS: While the average pain scores throughout labor did not differ significantly between groups, fewer patients in group 10q60 received physician-administered boluses for breakthrough pain (34.9% in 10q60 vs. 61.0% in 5q30 and 61.9% in CEI, P = 0.022). Dermatomal sensory levels, degree of motor block, and patient satisfaction did not differ significantly between groups. CONCLUSIONS: Our study suggests that high volume PIEB regimens for labor analgesia decrease breakthrough pain and physician-administered boluses.

Prevalence and characterization of breakthrough pain in cancer patients with proctalgia treated with 3D pelvic radiotherapy.

PURPOSE: Radiotherapy-induced dysfunction of the gastrointestinal tract is common in cancer patients and has a significant impact on their quality of life. In this study, we investigated the prevalence of breakthrough cancer pain (BTcP) in patients undergoing 3D pelvic radiotherapy and who had proctalgia. METHODS: This observational, multicenter, cross-sectional epidemiological study was performed in 13 Spanish hospitals. Data were obtained on the presence and characteristics of BTcP, demographics, common comorbidities, and treatments prescribed to the patients. RESULTS: The prevalence of BTcP in patients undergoing pelvic 3D external radiotherapy with proctalgia (N = 105) was 48.6% (95% CI 39.0-58.1%). BTcP was further characterized in 59 patients. The mean (± SD) intensity of the BTcP episodes was 7.45 ± 1.47 in a visual analog scale. We found several statistically significant associations between the descriptive variables of BTcP with demographic and clinical variables associated with the tumor or the patient, such as an increased number of BTcP episodes per day depending on the presence or absence of diabetes (p = 0.001, Chi-square) or time to the onset of pain relief depending on the location of the tumor (p = 0.019, Chi-square). Fentanyl was the drug of choice in BTcP episodes for 95% of the patients. CONCLUSIONS: This study demonstrated a high prevalence of BTcP prevalence in cancer patients undergoing pelvic 3D radiotherapy and with proctalgia. Although the variables determining the onset of BTcP are still unclear, our results could help in the design of future clinical studies addressing the treatment of BTcP in these patients.

Breakthrough Cancer Pain in Patients With Abdominal Visceral Cancer Pain.

OBJECTIVE: The objective of this study was to assess the characteristics of breakthrough cancer pain (BTcP) in patients with abdominal cancer pain, and the eventual factors associated with its presentation. METHODS: Patients with abdominal visceral cancer presenting BTcP were included in the analysis. Pain intensity, current analgesic therapy, number of BTcP episodes, intensity of BTcP, its predictability and triggers, onset (≤10 minutes or >10 minutes), duration, interference with daily activities, medications and doses currently used for BTcP, and time to meaningful pain relief were collected. Adverse effects imputable to a BTcP medication were recorded. RESULTS: Four hundred fourteen patients were included in the study. The mean background pain was 2.7 (SD 1.19) and most patients (97.6%) were receiving opioids. The mean number of BTcP episodes/day was 2.2 (SD 1.51). The mean intensity of BTcP was 7.3 (SD 1.32). BTcP onset was ≤10 minutes and >10 minutes in 271 (65.5%) and 143 patients (35.5%), respectively, and the mean duration was 52.6 minutes (SD 38.1). Interference of BTcP with daily activity was relevant for 340 patients (82%). In 122 patients (29.5%), BTcP was predictable and ingestion of food (n = 63, 51.6%) was the most frequent trigger. In comparison with unpredictable BTcP, postprandial BTcP had a lower intensity (P = 0.039), had a faster onset (P = 0.042), and was associated with the use of oxycodone/naloxone (P = 0.003), and less use of nonsteroidal anti-inflammatory drugs (P = 0.006). CONCLUSION: Patients with abdominal visceral BTcP represent a subgroup with specific features of BTcP, particularly those with predictable BTcP. Ingestion of food was the prominent trigger for BTcP, having a faster onset and a lower intensity. This group of patients more frequently used oxycodone/naloxone or no anti-inflammatory drugs. These findings suggest consequential therapeutic decisions.

Active study: undetected prevalence and clinical inertia in the treatment of breakthrough cancer pain (BTcP).

AIMS: To prove if there is clinical inertia in the identification and treatment of episodes of breakthrough cancer pain (BTcP), comparing actual results from clinical practice with clinical oncologists' prior perception. DESIGN: Observational and descriptive study, using information collected by practising medical oncologists, at three moments: (a) questionnaire regarding their professional judgement of the handling of patients with BTcP in their practice, (b) cross-sectional clinical screening, to detect possible existing cases of BTcP in a representative sample of their patients, (c) retrospective self-audit of clinical case histories of patients diagnosed with BTcP to find out about how it has been handled. PARTICIPANTS AND STUDY PERIOD: A random sample on a state level of 108 specialists in medical oncology. 540 patients who suffer some type of cancer pain on the designated study date for each specialist (July-December 2016). RESULTS: The global prevalence of BTcP in the study sample covered 91.3% of the patients who were suffering some type of cancer pain. Barely 2% of the doctors surveyed suspected figures around this mark. 40.9% of the cases had not been previously detected as BTcP by their doctors. Although 90% of the patients who had previously been diagnosed with BTcP received a specific analgesic treatment for the symptoms, 42% of those patients with known BTcP were not able to control their episodes of pain. CONCLUSIONS: Clinical inertia is a serious problem in the handling of BTcP in medical oncology services, where it is the subject of a significantly low level of detection and treatment, despite the contrasting perception of specialists.

Multimodal Postoperative Pain Control Is Effective and Reduces Opioid Use After Laparoscopic Roux-en-Y Gastric Bypass.

BACKGROUND: Opioids have been the mainstay for postoperative pain relief for many decades. Recently, opioid-related adverse events and death have been linked to postoperative dependency. Multimodal approaches to postoperative pain control may be part of the solution to this health care crisis. The safety and effectiveness of multimodal pain control regimens after laparoscopic Roux-en-Y gastric bypass (LRYGB) has not been well studied. The primary aim of our study was to determine if an evidence-based, multimodal pain regimen during hospitalization could decrease the total oral morphine equivalent (TME) use after LRYGB. STUDY DESIGN: We conducted a retrospective cohort study comparing outcomes prior to the implementation of a multimodal pain protocol (December 2010-December 2012) to those after implementation (April 2013-July 2015). The protocol utilized oral celecoxib and scheduled oral acetaminophen for pain control, with opioids used only as needed for breakthrough pain. Data was extracted from an electronic medical record and an institutionally maintained database of all patients undergoing bariatric surgery at a single center. RESULTS: Compared to controls, the multimodal pain regimen significantly reduced TME used and maximum pain scores with no change in mean pain scores. Multimodal pain protocol patients had a shorter length of stay with no increase in bleeding complications or marginal ulcer rates. CONCLUSIONS: An opioid-sparing multimodal pain regimen adequately controls pain while reducing TME use. The regimen appears to be safe and was associated with a reduced length of stay in patients undergoing LRYGB.

Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial.

OBJECTIVE: Examination of postoperative analgesia with intravenous and oral acetaminophen. DESIGN: Prospective, three-arm, nonblinded, randomized clinical trial. SETTING: A single academic medical center. SUBJECTS: Parturients scheduled for elective cesarean delivery. METHODS: This trial randomized 141 parturients to receive intravenous acetaminophen (1 g every eight hours, three doses), oral acetaminophen (1 g every eight hours, three doses), or no acetaminophen. All patients received a standardized neuraxial anesthetic with intrathecal opioids and scheduled postoperative ketorolac. The primary outcome, 24-hour opioid consumption, was evaluated using the Kruskal-Wallace test and Tukey-Kramer adjustment for multiple comparisons. Secondary outcomes included 48-hour opioid consumption, first opioid rescue, pain scores, patient satisfaction, times to ambulation and discharge, and side effects. RESULTS: Over 18 months, 141 parturients with similar demographic variables completed the study. Median (interquartile range) opioid consumption in intravenous morphine milligram equivalents at 24 hours was 0 (5), 0 (7), and 5 (7) for the intravenous, oral, and no groups, respectively, and differed between groups (global P = 0.017). Opioid consumption and other secondary outcomes did not differ between the intravenous vs oral or oral vs no groups. Opioid consumption was reduced at 24 hours with intravenous vs no acetaminophen (P = 0.015). Patients receiving no acetaminophen had 5.8 times the odds of consuming opioids (P = 0.036), consumed 40% more opioids controlling for time (P = 0.041), and had higher pain scores with ambulation (P = 0.004) compared with the intravenous group. CONCLUSIONS: Intravenous acetaminophen did not reduce 24-hour opioid consumption or other outcomes compared with oral acetaminophen. Intravenous acetaminophen did decrease opioid consumption and pain scores compared with no acetaminophen.

Estudio CRONO: prevalencia del dolor irruptivo en pacientes con dolor crónico no oncológico en Andalucía, España / CRONO study: prevalence of breakthrough pain in patients with non-cancer chronic pain in Andalusia, Spain

Objetivo: El objetivo de este estudio es evaluar la prevalencia de dolor irruptivo (DI) en pacientes ambulatorios con dolor crónico de origen no oncológico y caracterizar la fisiopatología, localización, intensidad y frecuencia de los episodios de DI. Material y métodos: Estudio observacional, prospectivo y no intervencionista realizado en 16 unidades de dolor ambulatorias de hospitales de Andalucía y Ceuta. Se preguntó a los pacientes consecutivos elegibles si experimentan DI definido como "una exacerbación transitoria del dolor que ocurre espontáneamente, o en relación con un desencadenante predecible o impredecible específico, a pesar del dolor de base estable y controlado". En cada día de la encuesta, los dos primeros pacientes que confirmaron DI fueron preguntados sobre las características clínicas de su PTP (etiología, inicio, intensidad, frecuencia y tratamiento). Resultados: Se realizó un cribaje a un total de 3209 pacientes con dolor crónico no oncológico para identificar a 1118 pacientes con DI, lo que representó una prevalencia del 36 %. Se obtuvieron las características del DI de 350 pacientes: la intensidad media fue de 8,3 (± 1,4) en una Escala Analógica Visual (EVA), con una media de 2 episodios/24 horas (rango 1-5/24 h). El mecanismo del dolor fue mixto en 149 (42,6 %), neuropático en 91 (26 %) y nociceptivo en 72 (20,6 %) de los pacientes. Se encontró correlación positiva entre una mayor intensidad de DI con el nivel de dolor basal (r = 0,243, p < 0,001), y el número de crisis diarias de DI (r = 0,123, p = 0,003), ambas estadísticamente significativas. El 78 % de los pacientes estaba en tratamiento con opioides. Los más frecuentes fueron el citrato de fentanilo (52,6 %) y el tramadol (17,4 %). Conclusiones: La tasa de prevalencia del DI en pacientes con dolor crónico no oncológico es superior a un tercio de los pacientes atendidos en las unidades ambulatorias de dolor hospitalario en España. El DI provoca niveles reducidos de funcionalidad, trastornos psicológicos y un aumento del gasto asistencial. La clave del tratamiento es la individualización

Objective: The aim of this study was to evaluate the prevalence of breakthrough pain (BTP) in ambulatory patients with non-cancer chronic pain in Spain and to characterize physiopathology, location, intensity and frequency of BTP episodes. Methods: Prospective, non-interventional, observational study conducted in 16 pain units of hospitals of Andalusia and Ceuta. Eligible consecutive patients were are asked if they experience BTP defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite stable and controlled background pain". At each survey day, the first two patients reporting BTP were further interrogated on the clinical characteristics of their BTP (etiology, onset, intensity, frequency and treatment). Results: A total of 3,209 patients with non-cancer chronic pain were screened to identify 1,118 patients with BTP, which represented a prevalence of 36 %. BTP characteristics were retrieved from 350 patients: mean BTP intensity was 8.3 (± 1.4) on a Visual Analogue Scale (VAS), with a mean of 2 episodes/24 hour (range 1-5/24 h). Pain mechanism was mixed in 149 (42.6 %), neuropathic in 91 (26 %) and nociceptive in 72 in (20.6 %) of patients. Significant correlation was found between BTP intensity and both higher background pain (r = 0.243, p < 0.001), and daily BTP episodes frequency (r = 0.123, p = 0.003). 78 % of the patients were on opioid treatment. The most frequent were fentanyl citrate (52.6 %) and tramadol (17.4 %). Conclusions: The prevalence rate of BTP in patients with chronic non-oncologic pain is higher than one-third of the patients seen in outpatient hospital pain units in Spain. BTP causes reduced levels of functionality, psychological disorders, and an increase in health care expenditure. Individualization is the key to treatment

[Fentanyl buccal tablets in the treatment of breakthrough cancer pain. German cohort of a pan-European multicentre study]. / Fentanyl-Buccaltabletten in der Behandlung von Durchbruchschmerzen : Deutsche Kohorte einer paneuropäischen multizentrischen Studie.

BACKGROUND: Patients with breakthrough cancer pain (BtCP) experience significant limitations in their physical, mental and social functions. Fentanyl buccal tablets (FBT), a rapid onset opioid, are specifically indicated for the treatment of BtCP. METHOD: The results of the German cohort of a pan-European study are presented. This included cancer pain patients from 32 German centers. Patients were on continuous opioid medication and had at least 4 BtCP episodes per day. After randomization to 2 groups, 66 patients started the titration of FBT with 100 µg (group A) and 200 µg (group B), respectively. All patients were titrated to their individual EAD, which could be a maximum of 800 µg FBT per episode, regardless of the initial dose. Subsequently, up to 8 BtCP episodes were treated with this EAD. At baseline and after treatment, patients assessed the effects of BtCP on their functional status using the modified BPI-7S and answered questions about the efficacy, simplicity, and ease-of-use of the treatment. RESULTS AND CONCLUSIONS: Successful titration was achieved by 49 patients (74.2%). There was no statistically significant difference between group A and group B. The global score of the modified BPI-7S increased by 8.5 (± 12.8) points (from 34.7 ± 13.6 at the beginning to 26.2 ± 15.8 at the end of treatment), from which a statistically significant improvement in the quality of life of patients can be derived. Global patient contentment improved, most notably the rapid onset of 2.4 points to 3.4 points at the end of the study. 76.9% of patients found taking FBT simple or very simple.

Prevalence and characteristics of breakthrough cancer pain in an outpatient clinic in a Catalan teaching hospital: incorporation of the Edmonton Classification System for Cancer pain into the diagnostic algorithm.

BACKGROUND: Breakthrough cancer pain (BTcP) is defined according to its principal characteristics: high intensity, short time interval between onset and peak intensity, short duration, potential recurrence over 24 h and non-responsiveness to standard analgesic regimes. The Edmonton Classification System for Cancer Pain (ECS-CP) is a classification tool that evaluates different dimensions of pain. The aim of this study was to measure prevalence and the main characteristics of BTcP in a sample of advanced cancer patients and to explore the complexity observed when ECS-CP is incorporated into BTcP diagnostics algorithm. METHODS: Descriptive prevalence study (Retrospective chart review). Davies' algorithm was used to identify BTcP and ECS-CP was used to recognize appropriate dimensions of pain. The study was conducted in a sample of advanced cancer patients attending hospital outpatient clinic in Lleida, Spain. 277 patients were included from 01/01/2014 to 31/12/2015. No direct contact was made with participants. The following information was extracted from the palliative care outpatient clinic database: age, gender, civil status, cognitive impairment status, functional performance status and variables related to tumour. Only BTcP cases were included. RESULTS: Prevalence of BTcP was 39.34% (63.9% men). Mean of age was 68.2 years. Main diagnosis was lung cancer (n = 154; 31.6%). Metastases were diagnosed in 83% of the sample. 138 patients (49.8%) were diagnosed with 1 type of BTcP and 139 (50.2%) were diagnosed with more than one type of BTcP. In total, 488 different types of BTcP were recorded (mean 1.75 ± 0, 9), 244 of these types (50%) presented a component of neuropathic pain. Addictive behaviour, measured through CAGE test, was present in 29.2% (N = 81) of the patients and psychological distress was present in 40.8% (n = 113). CONCLUSIONS: Prevalence of BTcP (39.34%) is similar to the one reflected in the existing literature. Study results indicate that the routine use of ECS-CP in a clinical setting allows us to detect more than one type of BTcP as well as additional complexity associated with pain (neuropathic, addictive behavior and psychological distress).

Incidence and risk factors for epidural re-siting in parturients with breakthrough pain during labour epidural analgesia: a cohort study.

INTRODUCTION: Epidural re-siting is one of the significant events during labour epidural analgesia that may result in decreased patient satisfaction. The aim of our study was to investigate the incidence of and factors associated with epidural re-siting in parturients using epidural analgesia, with an emphasis on those with breakthrough pain. METHODS: A retrospective cohort study of 10170 parturients who received labour epidural analgesia. The primary outcome was the incidence of epidural re-siting (binary data). Univariate and multivariate logistic regression analysis were performed to find associated risk factors for re-siting. RESULTS: Less than 1% (0.85%, 86/10170) of the women in the study had their epidural re-sited. Amongst the subset of women with breakthrough pain, the incidence of epidural re-siting was higher (4.7%, 68/1454). Most of the women who had their epidural re-sited had experienced breakthrough pain (79%, 68/86). Amongst all parturients, the presence of breakthrough pain (OR=21.31), hypotension (OR=4.18) and venous puncture (OR=2.74) were significantly associated with re-siting. Amongst the parturients with breakthrough pain who required epidural re-siting, lower cervical dilatation (OR=0.81), higher number of episodes of breakthrough pain (OR=1.83) and patchy block (OR=4.37) were significantly associated with re-siting. The areas-under-curves of two multivariate models were 0.894 and 0.806 respectively. CONCLUSION: In our institution, the incidence of epidural catheter re-siting was low in all patients. However, the majority of patients whose catheters were re-sited had exhibited breakthrough pain. The risk factors associated with the need for re-siting of catheters in all patients differed from those who had breakthrough pain.

Nonresponsiveness and Susceptibility of Opioid Side Effects Related to Cancer Patients' Clinical Characteristics: A Post-Hoc Analysis.

BACKGROUND: The response to opioids is not always positive in cancer patients. A considerable proportion of patients do not respond (nonresponders [NRs]) or experience severe toxicity. The aim of this analysis was to assess the role of demographic characteristics, pain features, comorbidities, and ongoing therapy on the lack of efficacy and on the occurrence of severe adverse drug reactions (ADRs). METHODS: This is a post-hoc analysis of a randomized controlled trial that involved 520 patients and aimed to evaluate the efficacy and safety of 4 strong opioids. Patients who presented with unchanged or worsened pain compared to the first visit were considered to be NRs. As for toxicity, severe ADRs with an incidence of greater than 10% were evaluated. Univariate and multivariate logistic models were used. RESULTS: 498 patients were analyzed. Liver metastases and breakthrough pain (BTP) were found to increase the risk for nonresponse. Conversely, a high basal pain intensity significantly decreased the same risk. Constipation risk was worsened by previous weak opioid therapy but decreased with aging and with the use of transdermal opioids. Risk for drowsiness was aggravated by bone metastases and concomitant treatment with anticoagulant, antidiabetic, and central nervous system drugs. Risk for confusion increased with antidiabetics, antibiotics, and previous weak opioid therapy but decreased when fentanyl was used. Occurrence of nausea increased in patients with a high rating on the Karnofsky Performance Status Index. Risk for xerostomia was higher in women and in patients treated with antidiabetic or long-term opioids. CONCLUSIONS: Several clinical variables are correlated with opioid response in cancer patients. In particular, the presence of BTP is associated with nonresponse. Additionally, patients who receive polypharmacological therapy are more likely to experience opioid adverse events.

Procedural Pain in Palliative Care: Is It Breakthrough Pain? A Multicenter National Prospective Study to Assess Prevalence, Intensity, and Treatment of Procedure-related Pain in Patients With Advanced Disease.

OBJECTIVE: To assess the prevalence of breakthrough pain (BTP) provoked by 6 common procedures in patients with advanced disease. METHODS: A prospective, cross-sectional, multicenter, national study was performed in 23 palliative care units in Italy. Patients were recruited if they were undergoing one of the following procedures as part of normal care: turning, personal hygiene care, transfer from bed to chair, bladder catheterization, pressure ulcer care, and subcutaneous drug administration. The Numerical Rating Scale was used to measure pain intensity before, during, and after the procedure. RESULTS: One thousand seventy-nine eligible patients were enrolled: 49.7% were male and their mean age was 78.0±11.2 years. Of all patients, 20.9% had experienced a BTP episode within the 24 hours before recruitment. The overall prevalence of procedure-induced BTP was 11.8%, and the mean intensity score (Numeric Rating Scale) was 4.72±1.81. Notably, patients experienced a significant increase in pain intensity during all procedures (P<0.0001). A small proportion of patients (12.7%) received analgesics before undergoing any of the procedures, and almost none (1.7%) received analgesics during the procedures to alleviate acute pain. DISCUSSION: Our findings highlight that simple daily care procedures can lead to BTP among patients with advanced disease. Because such procedures are performed very often during palliative care, more individualized attention to procedural pain control is necessary. Additional research on procedural pain in patients with advanced disease should be encouraged to provide further evidence-based guidance on the use of the available medication for predictable pain flares.

Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer.

OBJECTIVES: Breakthrough cancer pain (BTP) represents a treatment challenge. Objectives were to examine the prevalence and characteristics of BTP in an international sample of patients with cancer, and to investigate the relationship between BTP and quality of life (QoL). METHODS: This was an observational cross-sectional multicentre study. Participating patients completed self-report questionnaires on a touch-screen laptop computer, including the Brief Pain Inventory, Alberta Breakthrough Pain Assessment Tool (ABPAT) and European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ-C30). The study was performed in 17 centres in 8 countries and involved 4 languages (Norwegian, Italian, German and English). RESULTS: Records from a convenience sample of 978 patients with advanced cancer were analysed; mean age was 62.2 years, 48.3% were women and 84.4% had metastatic disease. A total of 296 patients (30%) had no pain, defined as worst pain in the past 24 hours <1 on a 0-10 scale. Of the 682 patients with a pain score ≥1, 393 (58%) reported no BTP on the screening item, while 289 (30%) confirmed flare ups of BTP. Patients with BTP reported significantly higher pain intensity scores (<0.001) than patients without BTP; 57.1% of patients rated BTP at its worst as being severe: ≥7 on a 0-10 scale. Time from onset to peak intensity was <10 min for 42.9%, and average time to pain relief was 27.1 min. BTP was commonly triggered by medication wearing off (28%). Patients with BTP had significantly worse mean outcomes on 10 of 15 functional and symptom scales of the EORTC QLQ-C30 (<0.001). Severe pain intensity in the last week was a powerful predictor of BTP (OR 4.1) and poor QoL (OR 1.9). CONCLUSIONS: BTP is highly prevalent with prolonged episodes despite analgaesics, and has a pervasive impact on QoL. Patients reporting high pain intensity should be carefully evaluated for BTP and efficacy of analgaesic treatment, to provide optimal pain management and improve QoL. TRIAL REGISTRATION NUMBER: NCT00972634; Results.