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.

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.

Objective:The aim of this study was to prospectively assess the efficacy and safety of sublingual fentanyl (SLF) in doses proportional to opioid doses used for background analgesia for the treatment of BTP of cancer patients. Methods:A sample of patients admitted to an acute palliative care unit, presenting breakthrough pain (BTP) episodes and receiving stable doses of opioids for background pain was selected to assess the efficacy and safety of SLF used in doses proportional to the basal opioid regimen used for the management of BTP. For each patient, data from four consecutive episodes were collected. For each episode, nurses collected changes in pain intensity and adverse effects when pain got severe (T0), and 5, 10, and 15 minutes after SLF was given (T15). Results:Seventy patients were recruited for the study. The mean age was 61.7 (AE11.5). Forty-one patients were males. A total of 173 episodes of BTP were recorded (mean 2.5 episodes/patient). In 19 events, documentation regarding changes in pain intensity was incomplete. Of the 154 evaluable episodes, 143 were successfully treated (92%). Mean doses of SLF were 637 mg (SD 786), and 51 patients (72.8%) received SLF doses !800 mg. When compared to younger adult patients, older patients received significantly lower doses of FBT (p50.0005), similarly to their lower basal opioid regimen. Pain intensity significantly decreased at T5, 10 and T15 (p50.0005). The number of patients with a pain reduction of more than 33% at T5, T10, and T15 were 11, 79, and 137, respectively, and the number of patients with a reduction in pain intensity of more than 50% were 1, 21, 114 at the same intervals, respectively. No differences in changes in pain intensity for gender (p50.9) or age (p50.85) were observed. No significant changes in the number of patients reporting adverse effects of mild-moderate intensity were reported after SLF administration in comparison with baseline, and no adverse effects severe enough in intensity to require medical intervention were observed. Limitations of this study are represented by the uncontrolled design. Conclusion:This study suggests that SLF given in doses proportional to the basal opioid regimen for the management of BTP is safe and effective in clinical practice.

The aim of this study was to present how opioids are used in an acute pain relief and palliative care unit (APRPCU), where many patients with difficult pain conditions are admitted from GPs, home palliative care programs, oncology departments, other hospitals or emergency units, and other regional places. From a consecutive sample of cancer patients admitted to an APRPCU for a period of 6 months, patients who had been administered opioids were included in this survey. Basic information was collected as well as opioid therapy prescribed at admission and, subsequently, during admission and at time of discharge. Patients were discharged once stabilization of pain and symptoms were obtained and the treatment was considered to be optimized. One week after being discharged, patients or relatives were contacted by phone to gather information about the availability of opioids at dosages prescribed at time of discharge. One hundred eighty six of 231 patients were specifically admitted for uncontrolled pain, with a mean pain intensity of 6.8 (SD 2.5). The mean dose of oral morphine equivalents in patients receiving opioids before admission was 45 mg/day (range 10-500 mg). One hundred seventy five patients (75.7 %) were prescribed around the clock opioids at admission. About one third of patients changed treatment (opioid or route). Forty two of 175 (24 %), 27/58 (46.5 %), 10/22 (45.4 %), and 2/4 (50 %) patients were receiving more than 200 mg of oral morphine equivalents, as maximum dose of the first, second, third, and fourth opioid prescriptions, respectively. The pattern of opioids changed, with the highest doses administered with subsequent line options. The mean final dose of opioids, expressed as oral morphine equivalents, for all patients was 318 mg/day (SD 798), that is more than six times the doses of pre-admission opioid doses. One hundred eighty six patients (80.5 %) were prescribed a breakthrough cancer pain (BTcP) medication at admission. Sixty five patients changed their BTcP prescription, and further 27 patients changed again. Finally, eight patients were prescribed a fourth BTcP medication. Of 46 patients available for interview, the majority of them (n = 39, 84 %) did not have problems with their GPs, who facilitated prescription and availability of opioids at the dosages prescribed at discharge. For patients with severe distress, APRPCUs may guarantee a high-level support to optimize pain and symptom intensities providing intensive approach and resolving highly distressing situations in a short time by optimizing the use of opioids.