Breakthrough pain in patients with abdominal cancer pain.

Abstract OBJECTIVE: Characterization of breakthrough cancer pain (BTcP) in patients with abdominal cancer is lacking. The aim of this study was to assess the characteristics of BTcP in patients with abdominal cancer pain. PATIENTS AND METHODS: In an observational cohort study, from a consecutive sample of patients admitted to a pain relief and supportive care unit for a period of 13 months, patients with abdominal disease due to cancer, including primary cancer or metastases, were assessed for the presence of chronic abdominal pain; its mechanism, intensity of background pain, and pain flares, which were distinguishable from the baseline pain, were recorded. Patients presenting with pain flares were assessed regarding the causes and the possible factors associated with it. Patients were reassessed when background pain control was considered optimal. RESULTS: From a sample of 522 patients admitted to an acute pain relief and palliative care unit in a period of 13 months, 100 patients with abdominal disease were available. The mean age was 65.3 years (SD\ub111.4); of the 100 patients, 45 (45%) were males. The mean Karnofsky status was 47.7 (SD\ub111.1). At admission (T0), 67 patients (67%) had background pain with mean pain intensity of 4.9 (SD\ub11.6). Sixty-one patients of those with background pain (91%) had superimposed and well-distinguished pain flares. After analgesic optimization (T1), the mean background pain intensity was 1.7 (SD\ub11.2), and 55.2% of patients had BTcP episodes. The difference with T0 was significant (P<0.0005). CONCLUSIONS: This preliminary study provides new insights on the characteristics of BTcP in a subclass of patients with abdominal disease. It has been estimated that about 55% of patients with well-controlled background pain will develop BTcP episodes. This percentage was higher (about 90%) in patients who presented with uncontrolled background pain, underlying the need to better characterize patients with BTcP, only after a careful optimization of basal pain, as considered by the definition of BTcP

Changes of QTc interval after opioid switching to oral methadone.

Abstract A consecutive sample of patients who were switched from strong opioids to methadone in a period of 1 year was surveyed. QTc was assessed before switching (T0) and after achieving adequate analgesia and an acceptable level of adverse effects (Ts). Twenty-eight of 33 patients were switched to methadone successfully. The mean initial methadone doses at T0 were 67.1 mg/day (SD \ub180.2, range 12-390). The mean QTc interval at T0 was 400 ms (SD \ub130, range 330-450). The mean QTc interval at Ts (median 5 days) was 430 ms (SD \ub126, range 390-500). The difference (7.7 %) was significant (p\u2009<\u20090.0005). Only two patients had a QTc of 500 ms. No serious arrhythmia was observed. At the linear regression analysis, there was no significant association between mean opioid doses expressed as oral morphine equivalents and QTc at T0 (p\u2009=\u20090.428), nor between mean methadone doses and QTc at Ts (p\u2009=\u20090.315). No age differences were found with previous opioid doses (p\u2009=\u20090.917), methadone doses (p\u2009=\u20090.613), QTc at T0 (p\u2009=\u20090.173), QTc at Ts (p\u2009=\u20090.297), and final opioid-methadone conversion ratio (p\u2009=\u20090.064). While methadone used for opioids switching seems to be an optimal choice to improve the opioid response in patients poorly responsive to the previous opioid, the possible QTc prolongation should be of concern despite not producing clinical consequences in this group of patients. A larger number of patients should be assessed to quantify the risk of serious arrhythmia

Spontaneous bilateral tubal pregnancy in a nulliparous woman. Laparoscopic diagnosis and treatment

A 34 year-old nulliparous woman was referred to our Department, complaining of vaginal bleeding and intermittent lower abdominal cramping. serum level of β-hCG was 4954 IU/L. Transvaginal ultrasound examination revealed no gestational sac in the uterine cavity and a right adnexal mass, suggestive of ectopic pregnancy; left adnexal area appeared regular. At laparoscopy, the presence of an ectopic pregnancy was confirmed in the right tube; on the left side, surprisingly, there was an intact infundibular ectopic pregnancy. Right tuba was removed; considering the condition of nulliparous of the patient, we decided to perform a linear salpingostomy. Histologic exam confirmed the diagnosis of spontaneous bilateral tubal ectopic pregnancies

Dosing fentanyl buccal tablet for breakthrough cancer pain: dose titration versus proportional doses

Abstract OBJECTIVES: The aim of this study was to compare the efficacy and safety of doses of fentanyl buccal tablet (FBT) proportional to doses of opioids used for background analgesia versus dose titration starting with the minimal dose for the management of breakthrough cancer pain (BTcP). METHODS: A total of 82 cancer patients with BTcP who were receiving strong opioids in doses of at least 60 mg of oral morphine equivalents and having acceptable background analgesia, were selected for a multicenter unblinded study. Forty-one patients were randomized to receive FBT in doses proportional to the daily opioid doses for four consecutive episodes of BTcP (group P). Forty-one patients underwent dose titration of FBT, with an initial dose of 100 µg, for four consecutive episodes (group T). Pain intensity and symptoms associated with opioid therapy were measured before administering any dose of FBT (T0) and 15 minutes after (T15). RESULTS: In all, 80 patients were considered for analysis (39 and 41 patients in group P and T, respectively). Patients were receiving a mean of 126 ± 100 mg of oral morphine equivalents (range 60-480 mg) for background analgesia. A total of 293 episodes of BTcP (144 and 149 in group P and T, respectively) were treated and considered for analysis. No differences were found in the decrease of pain intensity between the two groups. However, in patients receiving doses of oral morphine equivalents of >120 mg/day, a significant number of patients obtained a decrease in pain intensity >50% in group P in comparison with group T (p = 0.040). Also, the need for rescue medication was significantly more frequently reported in group T for the first episode of BTcP (p < 0.0005). No differences in the level of adverse effects were observed between the two groups. No differences in patients' satisfaction were reported. CONCLUSION: According to the data obtained in this study, there is no evidence for the use of dose titration in the management of BTcP in opioid-tolerant patients. Indeed, doses proportional to basal opioid regimen for background pain seem to be effective and safe in the majority of patients. Further studies should confirm this data in patients receiving higher doses of opioids, with other rapid-onset opioids, and in other settings

Episodic breathlessness with and without background dyspnea in advanced cancer patients admitted to an acute supportive care unit

Aim: To characterize episodic breathlessness (EB) in patients with advanced cancer, and to determine factors influencing its clinical appearance. Methods: A consecutive sample of advanced cancer patients admitted to an acute palliative care unit was surveyed. Continuous dyspnea and EB were measured by a numerical scale. The use of drugs used for continuous dyspnea and EB was recorded. Patients were asked about the characteristics of EB (frequency, intensity, duration and triggers). The Multidimensional dyspnea profile (MDP), the Brief dyspnea inventory (BDI), the Athens sleep scale (AIS) and the Hospital Anxiety and Depression Scale (HADS) were also administered. Results: From 439 advanced cancer patients surveyed, 34 and 27 patients had EB, without and with background dyspnea, respectively. The mean intensity and the number of episodes were higher in patients with background dyspnea (p &lt; 0.0005 and p = 0.05, respectively). No differences in duration were observed. Most episodes lasted &lt;10 min. A recognizable cause triggering EB was often found. The presence of both background dyspnea and EB was associated with higher values of MDP and BDI. EB was independently associated with frequency and intensity of background dyspnea (OR = 20.9, 95% CI (Confidence interval) 9.1–48.0; p &lt; 0.0005 and OR = 1.97, 95% CI 1.09–3.58; p = 0.025, respectively) and a lower Karnofsky level (OR = 0.96, 95%CI 0.92–0.98, p = 0.05). Discussion: EB may occur in patients with and without continuous dyspnea, and is often induced by physical and psychological factors. EB intensity is higher in patients with continuous dyspnea. The duration was often so short that the use of drugs, as needed, may be too late, unless administered pre-emptively when the trigger was predictable

Prognostic factors of survival in patients with advanced cancer admitted to home care

Abstract CONTEXT: Data regarding prognostication of life expectancy in patients with advanced cancer are of paramount importance to patients, families, and clinicians. However, data regarding patients followed at home are lacking. OBJECTIVES: The aim of this study was to evaluate the correlation between various factors recorded at the beginning of home care assistance and survival. METHODS: A sample of consecutive patients admitted to two home care programs was surveyed. A preliminary consensus was achieved as to the possible variables easy to be recorded at home. These included age at the time of home care admission, gender, residence, marital status, primary cancer diagnosis, Karnofsky Performance Status (KPS) score, measures of systolic blood pressure and heart rate, cyanosis, use of oxygen, and body temperature. The Edmonton Symptom Assessment System was used to record the intensity of each symptom. Patients were divided into two groups: patients with a survival of less than 10 days (short survival) and patients with a survival of 10 days or more (medium-long survival). RESULTS: Three hundred seventy-four consecutive patients admitted to home care programs were surveyed, of which 187 were male. The mean\ub1SD age was 72.1\ub112.7 years. The mean survival was 56.2\ub165 days. Mean survival was 71.5\ub167 days (287 patients) and 5.6\ub12.7 days (87 patients) in the short and medium-long survival groups, respectively. No association between type of tumor and survival was observed (P=0.162). Univariate logistic regression analysis revealed that male gender (P=0.020), older age (P=0.012), lower KPS scores (P<0.0005), systolic blood pressure less than 100 mmHg (P=0.003), heart rate greater than 100 beats per minute (P=0.0006), delirium (P=0.004), the use of oxygen (P=0.002), intensity of fatigue (P=0.006), drowsiness (P<0.0005), anorexia (P<0.0005), dyspnea (P<0.0005), poor sense of well-being (P<0.0005), and distress score (P<0.0005) were associated with a survival of less than 10 days. Marital status, residence, cognitive function, fever, pain, depression, and anxiety were not found to be significantly correlated with survival. In a multiple logistic regression model, low systolic blood pressure and high heart rate, gender, delirium, use of oxygen, KPS score, drowsiness, anorexia, and dyspnea were significantly correlated with a shorter survival. CONCLUSION: Low systolic blood pressure and high heart rate, male gender, poor KPS score, anorexia, and dyspnea were correlated with a shorter survival. Moreover, patients with low systolic blood pressure and high heart rate, male gender, poor KPS score, and greater intensity of anorexia and dyspnea are more likely to die within one week. The combination of physical symptoms from the Edmonton Symptom Assessment System and other parameters included in this study, which are simple to assess and are repeatable at home, should be further explored in future studies to provide a simple tool for use with patients with advanced cancer admitted to a home care program

Pain intensity as prognostic factor in cancer pain management

Aim: The aim of this study was to prospectively assess the prognostic value of initial pain intensity and its duration in advanced cancer patients. Methods: A prospective study was conducted in a sample of patients with cancer requiring pain control. Patients underwent standard analgesic strategies used in our palliative care units. Pain intensity was measured at admission (T0) and after successful dose titration or opioid/route switching within a week (Ts). Patients were also asked about their pain intensity reported 15 days before admission (T-15). Doses of opioids and duration of opioid use were recorded. Patients were also assessed for the presence of incident pain, neuropathic pain, alcoholism, delirium, and symptom intensity, including items representing psychological distress. One week after or at time of stabilization (Ts), the opioid response was clinically graded as follows: (1) good pain control; (2) adequate pain control requiring more aggressive opioid escalation; (3) adequate pain control associated with the occurrence of adverse effects; (4) incapacity to achieve pain control within a week. Opioid escalation indexes and days for dose finding were also recorded. Results: Pain intensity at T0 and at T-15, opioid doses, duration of opioid therapy, and age were associated with more complex analgesic therapies, which were effective in almost all patients within a week. Conclusion: High levels of pain intensity, often due to previous undertreatment, are predictive of more complex analgesic treatment. Opioid tolerance, as well as younger age, may also play a role

Meaningful cut-off pain intensity for breakthrough pain changes in advanced cancer patients

Abstract OBJECTIVES: To assess the level of pain intensity at which patients feel the impetus to ask for a breakthrough cancer pain (BTcP) medication, and level of pain intensity at which patients consider they have achieved acceptable pain control after receiving a BTcP medication. METHODS: A consecutive sample of patients who were receiving oral morphine equivalents equal to or more than 60\u2009mg daily, and were prescribed rapid onset opioids for the management of episodes of BTcP, were included in the study. Focused educational activities regarding BTcP and numerical scales were established during hospital admission. At discharge patients were interviewed to find out what was the pain intensity level which gave the impetus to take the BTcP medication, what was the pain intensity for acceptable pain control after a BTcP medication had been given, and which factors prevented the patient calling for BTcP medication. A brief COPE (coping orientation to problems experienced) questionnaire was also administered. RESULTS: Fifty-two patients were recruited for this study. The meaningful pain intensity for asking for a BTcP medication was 7.1; 77% of patients had a pain intensity of 7-8 on a numerical scale of 0-10. The meaningful pain intensity for adequate analgesia after a BTcP medication was 3.5. Similarly, 77% of patients had a pain intensity of 3-4. There was no relationship with the variables examined. Concerns by patients about the use of BTcP medications were minimal. CONCLUSION: The meaningful BTcP intensity and pain intensity expected after BTcP medication can be useful in selecting patients in studies of BTcP. The principal limitation of this study was the specific setting of an acute unit with specific features and the relatively low number of patients. This observation should be followed up by further surveys with a larger number of patients and different settings