Randomized Trial of Low-Dose Morphine Versus Weak Opioids in Moderate Cancer Pain.

PURPOSE: The WHO guidelines on cancer pain management recommend a sequential three-step analgesic ladder. However, conclusive data are lacking as to whether moderate pain should be treated with either step II weak opioids or low-dose step III strong opioids. PATIENTS AND METHODS: In a multicenter, 28-day, open-label randomized controlled study, adults with moderate cancer pain were assigned to receive either a weak opioid or low-dose morphine. The primary outcome was the number of responder patients, defined as patients with a 20% reduction in pain intensity on the numerical rating scale. RESULTS: A total of 240 patients with cancer (118 in the low-dose morphine and 122 in the weak-opioid group) were included in the study. The primary outcome occurred in 88.2% of the low-dose morphine and in 57.7% of the weak-opioid group (odds risk, 6.18; 95% CI, 3.12 to 12.24; P < .001). The percentage of responder patients was higher in the low-dose morphine group, as early as at 1 week. Clinically meaningful (≥ 30%) and highly meaningful (≥ 50%) pain reduction from baseline was significantly higher in the low-dose morphine group (P < .001). A change in the assigned treatment occurred more frequently in the weak-opioid group, because of inadequate analgesia. The general condition of patients, which was based on the Edmonton Symptom Assessment System overall symptom score, was better in the morphine group. Adverse effects were similar in both groups. CONCLUSION: In patients with cancer and moderate pain, low-dose morphine reduced pain intensity significantly compared with weak opioids, with a similarly good tolerability and an earlier effect.

Is pain reporting to health care professionals age-related? A cross sectional multicenter study in a hospital setting.

BACKGROUND: Failure to report pain by older patients is usually considered a major obstacle to receive adequate pain management. OBJECTIVES: To compare the frequency of reporting pain to health care professionals (HCPs) among older (≥ 65 yrs) and younger adults (< 65 yrs) and to evaluate whether age and setting of care influence pain reporting to HCPs. RESULTS: Overall, 3285 patients (54.7 ≥ 65 yrs) were interviewed. Despite analgesic therapy, 2821 patients had pain. Among these, 1178 patients (41.8%) had severe pain. The frequency of patients not reporting pain to HCPs is significantly lower among older vs. younger adults (18.1 vs. 23.6%; p < 0.001). Multiple multilevel logistic regression, however, shows that nonreporting pain is not age-related, but is associated with: nonmalignant pain (OR = 1.53; 95% CI: 1.00 - 2.35; p = 0.05), a short hospitalization (OR = 1.58; 95% CI: 1.20 - 2.07; p = 0.001), admission to a hospital without a 'pain-free hospital' project (OR = 2.00; 95% CI: 1.18 - 3.39; p = 0.011). CONCLUSIONS: The results suggest that failure to report pain does not appear to be associated with the age of the patient in itself, but with type of pain and clinical context. Both patients and physicians should be encouraged to actively address pain management. Further research is needed.

[ProMoFIA_Oncologic: monitoring project of the innovative oncology drugs in Abruzzo]. / ProMoFIA_Oncologici: Progetto di Monitoraggio dei Farmaci Oncologici Innovativi in Abruzzo.

INTRODUCTION: The unmet therapeutic needs lead to accelerated registration of new oncology drugs, even with incomplete information of the benefit-risk ratio. METHODS: In Italy the Onco-AIFA Register was established to monitor oncology drugs when used according to authorized indications and to assure their appropriate use in clinical practice. In the Abruzzo region, an observational longitudinal study (ProMoFIA_Oncologici) was performed to evaluate in standard clinical practice all patients treated with these new oncology drugs for any indication. RESULTS: During the period 2008-2011, 3435 patients were observed: in 62.2% of patients, the use of these drugs was eligible also for the Onco-AIFA Register; in 22.7% it was in-label but not monitored in the Onco-AIFA; in 15.1% the use was off-label. DISCUSSION: The study findings showed a widespread use of the new oncology drugs beyond the Onco-AIFA indications, as well as their off-label use.

[The ECAD_O project: clinical caring epidemiology of pain in the hospital: the nurses' contribution]. / Il modello di sorveglianza ECAD_O-Epidemiologia Clinico-Assistenziale del Dolore in Ospedale: il contributo degli infermieri.

AIMS: ECAD_O is a project aimed to establish a surveillance of pain treatment--as part of routine care and as a hospital pharmacovigilance activity--with the following objectives: to assess in each participant ward prevalence of patients exposed to analgesics; to describe the pharmacological management schedules; to document the perception of health-care professionals on the effectiveness of treatment administered; to identify groups of patients whose pain is undertreated, through the activation of a collaborative protocol. METHODS: A multicentre (48 hospitals) and multidisciplinary (nurses, clinicians, pharmacists) cross-sectional survey was conducted in 6 index-days. Epidemiological, clinical and therapeutic data were collected and heath-care professionals (nurses or clinicians) were asked about their perception on the effectiveness of treatment administered and the reasons of non-effectiveness. RESULTS: In the 164 participant wards (61 surgery, 46 medicine, 28 oncology, 22 orthopaedics, 7 other) 3854 patients (20.9% of inpatients) were exposed to analgesics. The majority of patients (84.3%) received analgesics around-the-clock. Opioid analgesics were administered around-the-clock (64.7%; 2103/3250) as well as only as needed (27.1%; 164/604). According to health-care professionals, analgesic therapy administered was not effective in 516 patients (13.4% of sample). Inspite of this evaluation, 288 patients did not receive rescue therapy, because it was not prescribed (180 patients) or not administered even if prescribed (108 patients). CONCLUSIONS: The establishment of a surveillance scheme which could be adopted in the routine conditions of care to monitor the quality of pain control has been successfully tested on the basis of multidisciplinary teams where the nurse personnel plays a key role.

[Clinical-caring epidemiology of pain at the hospital--the ECAD-O project]. / Programma ECAD-O--Epidemiologia Clinico-Assistenziale del Dolore in Ospedale.

UNLABELLED: Pain continues to be underreported and undertreated, and resistances to the administration of morphine and opioids are one of the major drawbacks. AIMS: a. to activate a surveillance as part of routine care; b. to produce periodical reports to follow-up any improvement or changes in oppioid and specifically treatment of pain; c. to the groups of patients whose pain is undertreated; d. to create a multicentre network of hospitals willing and able to promote a permanent surveillance on pain and its treatment. METHOD: A cross sectional survey will be conducted in index days to collect data on the number of patients exposed to analgesics; the perception of health workers on the effectiveness of treatments administered; patients' satisfaction on pain control. A prospective surveillance on: a. adverse events; b. incident difficult cases (patients whose pain is not controlled or difficult to treat, e.g. because of comorbidities or contraindications to opioids). EXPECTED RESULTS: Data produced will be analysed and presented for each participating centre and will be used for education, audit and quality improvement.