[Recommendations for the perioperative use of dipyrone : Expert recommendation of the working group on acute pain of the German Pain Society, the scientific working group on pain medicine of the German Society for Anesthesiology and Intensive Care Medicine and the surgical working group on acute pain of the German Society for Surgery with participation of representatives of the Drug Commission of the German Medical Association]. / Empfehlungen zur perioperativen Anwendung von Metamizol : Expertenempfehlung des Arbeitskreises Akutschmerz der Deutschen Schmerzgesellschaft, des Wissenschaftlichen Arbeitskreises Schmerzmedizin der Deutschen Gesellschaft für Anästhesiologie und Intensivmedizin und der Chirurgischen Arbeitsgemeinschaft Akutschmerz der Deutschen Gesellschaft für Chirurgie unter Beteiligung von Vertretern der Arzneimittelkommission der deutschen Ärzteschaft.

BACKGROUND: Dipyrone (metamizole) is widely used for perioperative pain management in countries where it is marketed; however, uncertainty exists concerning the safe use of this drug, specifically considering the rare adverse event of an agranulocytosis. METHODS: As evidence from published studies was lacking, an expert panel developed recommendations for the perioperative use of dipyrone. After a formal, structured consensus process, the recommendations were approved by the involved medical societies. RESULTS: The panel agreed that blood cell counts shall not be standard for short-term perioperative use in patients unless they are at risk for neutropenia. The medical staff shall be aware of the symptoms and course of action when agranulocytosis is suspected. Patients shall be informed about the risks and benefits of dipyrone and about potential alternatives. The expert group concluded that dipyrone has a relatively positive risk-benefit ratio compared to other nonopioid analgesics. The group strongly recommended educating patients about the symptoms of agranulocytosis if they have received dipyrone over several days and/or treatment is to be continued after discharge, because agranulocytosis can occur several days after discontinuation of metamizole. Further recommendations refer to the information of the physician taking over the patient's care after discharge and the avoidance of re-exposure in patients having previously suffered from dipyrone-induced agranulocytosis. CONCLUSION: The group's recommendations shall be communicated in order to raise medical staff's and patients' awareness of the appropriate use of dipyrone in the perioperative period.

[Recommendations for the perioperative use of dipyrone : Expert recommendation of the working group on acute pain of the German Pain Society, the scientific working group on pain medicine of the German Society for Anesthesiology and Intensive Care Medicine and the surgical working group on acute pain of the German Society for Surgery with participation of representatives of the Drug Commission of the German Medical Association]. / Empfehlungen zur perioperativen Anwendung von Metamizol : Expertenempfehlung des Arbeitskreises Akutschmerz der Deutschen Schmerzgesellschaft, des Wissenschaftlichen Arbeitskreises Schmerzmedizin der Deutschen Gesellschaft für Anästhesiologie und Intensivmedizin und der Chirurgischen Arbeitsgemeinschaft Akutschmerz der Deutschen Gesellschaft für Chirurgie unter Beteiligung von Vertretern der Arzneimittelkommission der deutschen Ärzteschaft.

BACKGROUND: Dipyrone (metamizole) is widely used for perioperative pain management in countries where it is marketed; however, uncertainty exists concerning the safe use of this drug, specifically considering the rare adverse event of an agranulocytosis. METHODS: As evidence from published studies was lacking, an expert panel developed recommendations for the perioperative use of dipyrone. After a formal, structured consensus process, the recommendations were approved by the involved medical societies. RESULTS: The panel agreed that blood cell counts shall not be standard for short-term perioperative use in patients unless they are at risk for neutropenia. The medical staff shall be aware of the symptoms and course of action when agranulocytosis is suspected. Patients shall be informed about the risks and benefits of dipyrone and about potential alternatives. The expert group concluded that dipyrone has a relatively positive risk-benefit ratio compared to other nonopioid analgesics. The group strongly recommended educating patients about the symptoms of agranulocytosis if they have received dipyrone over several days and/or treatment is to be continued after discharge, because agranulocytosis can occur several days after discontinuation of metamizole. Further recommendations refer to the information of the physician taking over the patient's care after discharge and the avoidance of re-exposure in patients having previously suffered from dipyrone-induced agranulocytosis. CONCLUSION: The group's recommendations shall be communicated in order to raise medical staff's and patients' awareness of the appropriate use of dipyrone in the perioperative period.

[Is supplemental ear acupuncture for surgical tooth removal with local anesthesia effective? : A pilot study]. / Ist die Supplementierung der Ohrakupunktur bei operativer Zahnentfernung in Lokalanästhesie effektiv? : Eine Pilotstudie.

BACKGROUND: The application of ear acupuncture can contribute to a reduction of acute pain. Data on the application of ear acupuncture following oral surgery in odontology is insufficient. OBJECTIVE: This study investigated the effectiveness of ear acupuncture as an auxiliary analgesic treatment in addition to local anesthesia for operative tooth removal. METHODS: In this prospective open non-randomized pilot study (in accordance with the CONSORT publication) 2 cohorts of 50 patients each with the indications for an operative tooth removal either with or without the application of ear acupuncture in addition to local anesthesia with articain were observed. Patients were allocated to the groups according to their preference. Pain intensity while resting and while chewing was recorded as the primary parameter for a period of 10 days. The secondary parameters were the subjective experience of anxiety and symptoms, such as headaches, dizziness and nausea. RESULTS: The two groups did not differ significantly with respect to demographic variables or the use of local anesthetics. At the various measurement intervals, pain intensity while resting or chewing differed significantly between the two groups (ANOVA, p = 0.004, p = 0.007, respectively). Furthermore, the experience of anxiety (ANOVA, p = 0.0001), the number of patients taking analgesics (χ2-test, p = 0.017) and the total postoperative consumption of analgesics (t-test, 0.001) revealed significant differences. In both groups the numerical rating scales (NRS) for postoperative headaches, dizziness and nausea were low. DISCUSSION AND CONCLUSION: Despite a potential bias and methodological limitations of the study design, the results of this investigation suggest that ear acupuncture influences the experience of pain and anxiety in the postoperative period after tooth removal. As a treatment method with low adverse effects ear acupuncture can contribute to postoperative pain control, especially in patients with preoperative anxiety.

[Dipyrone (metamizole) : Considerations on monitoring for early detection of agranulocytosis]. / Metamizol : Überlegungen zum Monitoring zur frühzeitigen Diagnose einer Agranulozytose.

BACKGROUND: Dipyrone (metamizole) is a non-opioid analgesic commonly used in Germany, which can, in very rare cases, cause life-threatening agranulocytosis. The prescribing information calls for regular monitoring of the differential blood count in cases of long-term treatment. However, there is uncertainty about how this testing should be handled in practice. OBJECTIVES: Which recommendations can be derived from the published literature for evaluating blood cell counts during treatment with metamizole and which other options for monitoring exist? METHODS: Data from recent epidemiological studies, reviews, and spontaneously reported cases were evaluated. RESULTS: Agranulocytosis can emerge at highly variable intervals ranging from the first day of metamizole treatment to months after treatment has begun. As a result, there is no conclusive, evidence-based recommendation for the time intervals at which blood cell counts should be tested. Therefore, the onset of clinical symptoms should be used as trigger for monitoring blood cell counts to enable early diagnosis and avoid agranulocytosis-related complications. In addition to general symptoms like fever, sore throat, fatigue, and muscle pain, mucosal ulcerations, severe angina, and systemic infections leading to sepsis are typical of agranulocytosis. CONCLUSIONS: Providing patients and medical staff with better information about early symptoms of agranulocytosis could be a sensible way to prevent complications. Any suspicion of agranulocytosis should immediately lead to a differential blood count and to the withdrawal of all drugs possibly associated with agranulocytosis. Patients should be monitored and treated according to the severity of their symptoms.

[Mechanisms of chronification and potential addiction in tumor pain : Comparison with non-tumor pain - A review of the literature]. / Chronifizierungsmechanismen und Abhängigkeitspotenziale bei Tumorschmerz : Vergleich mit Nichttumorschmerz ­ eine Literaturübersicht.

BACKGROUND: Due to advances in oncological therapy options and increasing survival rates, the number of cancer patients with persistant pain, who are in need of analgesic therapy has increased. It has been proven that biopsychosocial mechanisms exist in patients with persistant non-cancer pain leading to chronification. Furthermore, addiction has been identified as a complication of analgesic therapy. OBJECTIVE: Can the multidimensional model of chronic pain enhancement and chronification be used for patients with cancer pain, analogue to patients with non-cancer pain? Can addiction sydromes as a result of analgesic treatment be demonstrated? MATERIAL AND METHODS: In this non-systematic review, a literature search was carried out for somatic and psychosocial chronification mechanisms in patients with cancer pain. Indications for potential addiction syndromes in cancer patients are demonstrated based on selected publications. A Medline search provided a number of relevant publications that are listed (see Supplementary Material). RESULTS AND DISCUSSION: Somatic chronification mechanisms, such as pain intensity, repetitive algesic stimuli, topical and demographic factors, are found both in persistant non-cancer pain and cancer pain. Cancer-induced peripheral and central sensitization mechanisms that can be due to underlying genetic variations, are specific for cancer pain. With regard to psychosocial determinants for pain chronification, both cancer and non-cancer patients show similar patterns. Furthermore, data from the literature support the existence of addiction in cancer patients. CONCLUSION: In order to optimize treatment more attention should be paid to the risk of chronification and addiction in cases of chronic persistant cancer pain.

[Serotonin syndrome and pain medication : What is relevant for practice?]. / Serotoninsyndrom und medikamentöse Schmerztherapie : Was ist für die Praxis relevant?

Serotonin syndrome is a dangerous and rare complication of a pharmacotherapy and can lead to death. Caused by unwanted interactions of serotonergic drugs, it is characterised by a neuroexcitatory triad of mental changes, neuromuscular hyperactivity and autonomic instability. Opioids with serotonergic effects include the phenylpiperidine series opioids fentanyl, methadone, meperidine and tramadol and the morphine analogues oxycodone and codeine. In combination with certain serotonergic drugs, e.g. antidepressants, they can provoke serotonin syndrome. In patients with such combinations, special attention should be paid to clinical signs of serotonergic hyperactivity. Higher risk combinations (e.g. monoamine oxidase inhibitors with tramadol) must be avoided. Treatment with serotonergic agents must be stopped in moderate or severe serotonin syndrome. Patients with a severe serotonin syndrome require symptomatic intensive care and specifically a pharmacological antagonism with cyproheptadine or chlorpromazine.

[Standardized treatment protocols in acute postoperative pain therapy: analysis of contents of standardized medicinal concepts]. / Behandlungsstandards in der postoperativen Akutschmerztherapie: Analyse von Inhalten standardisierter medikamentöser Konzepte.

BACKGROUND: Standardized treatment approaches can improve the quality of the management of acute postoperative pain. AIM: The purpose of this study was to describe the content and structure of currently implemented standards for the management of acute postoperative pain in German hospitals and to better define the concept of a treatment standard for acute pain. MATERIAL AND METHODS: Written standardized treatment protocols from 68 hospitals for the management of acute postoperative pain were analyzed. The evaluation was based on the layout of processes, the baseline and rescue or on-demand analgesic medication and safety mechanisms. RESULTS: A treatment standard per hospital separated for adults (68 standards) and children (27 standards) was identified and analyzed. A baseline medication was provided in all standards for adults and in 89% for children. Of the 95 standards 68% routinely combined opioids and non-opioids as a basis (78% for adults and 42% for children). A way to adapt the baseline medication was described more often in standards for adults. Of the standards for adults 91% (85% for children) contained provisions for rescue or on-demand analgesia and half of them (both adults and children) included an immediate-release opioid formulation, which was readily available. For adults the availability was regulated by a predefined process in 29% of the standards (8% for children). In cases of persisting pain, repetition of the rescue medication was generally possible in 63% of adult standards (54% for children) but within 1 h after the first dose in only 43% (30% for children). Intervention limitations for application of the rescue medication (e.g., a defined score on the numeric rating scale) were set in 63% of adult standards (54% for children). A follow-up assessment of the pain intensity after a rescue medication was only required in approximately half of the standards and safety information or mechanisms were only rarely included. CONCLUSION: Content, structure and type of the evaluated treatment standards showed a considerable heterogeneity with respect to the availability of rescue and baseline medication. Safety aspects were not addressed in many cases. These findings show that despite the requirements of the German guidelines for treatment of perioperative and posttraumatic pain for treatment standards, there are still no practical recommendations with respect to contents and structure of such standards.

[Rapid release fentanyl administration forms. Comments of the Working Group on Tumor Pain of the German Pain Society]. / Schnell freisetzende Fentanylapplikationsformen. Stellungnahme des Arbeitskreises Tumorschmerz der Deutschen Schmerzgesellschaft.

The spectrum of indications for rapid release fentanyl preparations is controversial. For this reason the Working Group on Tumor Pain will formulate comments on how to deal with these substances. Breakthrough pain should receive individualized therapy; therefore, the use of opioids of various galenic formulations seems to be advisable. New rapid release fentanyl preparations are suitable for alleviating spontaneous breakthrough pain in tumor patients due to a rapid but short-acting effect. However, a prior optimization of the analgesic basis medication is absolutely necessary. Uncontrolled prescription for non-cancer pain must be criticized due to the problem of addiction. The medical profession should be informed about the benefits of rapid release fentanyl preparations but must also be made aware of the risk of a rapid development of addiction and tolerance. A self-commitment of the pharmaceutical industry to waive advertising for the dangerous off-label use would be desirable. In the opinion of the Working Group on Tumor Pain the use of fentanyl should be openly discussed and further scientific investigations are imperative with the aim of formulating clear recommendations.

[Polypharmacy and medication review in the context of prehabilitation]. / Polypharmazie und Medikamentencheck im Kontext der Prähabilitation.

Against the background of typical geriatric multimorbidity and with the particular vulnerability of geriatric patients, polypharmacy deserves special attention. In accordance with the guidelines, medication should not only be reviewed regularly, but also on an ad hoc basis and with each hospital stay-and also in the context of prehabilitation. Thus, not only substances that interfere with the currently planned intervention, anesthesia, or risk of bleeding should be considered, but any medication that increases common risks for geriatric patients. These include drugs that cause or increase a tendency to fall, induce delirium, or alter the comedication through potential drug-drug interactions. Measures to minimize the risk include the following: exact documentation of medications, structured and complete transfer of information, patient and family training about any side effects that may occur, a recall system for possible laboratory checks, and compliance with the instructions for taking the medication.

Laxative management in ambulatory cancer patients on opioid therapy: a prospective, open-label investigation of polyethylene glycol, sodium picosulphate and lactulose.

Constipation and the laxatives polyethylene glycol (PEG), sodium picosulphate (SPS) and lactulose (L) were investigated in outpatients with cancer and on opioid therapy. Randomly selected patients were enrolled in a prospective, controlled, open-label trial. Endpoints were number of patients taking laxatives >28 days, number of patients with a stool-free interval >72 h (sfi72), dosage, numerical rating scale (NRS) for constipation, and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) questionnaire scores. The 348 patients had comparable demographic and medical data. In this ambulatory population, mobility scores remained unaffected. Constipation incidence was 5.7%, with sfi72 42, mean NRS 2.3557 and mean QoL 2.1. A total of 53.2% discontinued their laxative medication. Laxative use correlated with higher opioid usage (morphine-equivalent mg/day: no laxative 98.2, SPS 128.2, PEG 139.9, L 154.5). PEG was the most frequently prescribed laxative (PEG 27.3%, SPS 10.3%, L 9.2%). PEG (sfi72 12.6%, NRS 2.2, QoL 2.1) and SPS (sfi72 11.1%, NRS 2.7, QoL 2.2) proved more effective than L (sfi72 15.5%, NRS 3.8, QoL 2.5). In spite of opioid therapy, the incidence of constipation was low in these ambulatory cancer pain patients at an early disease stage. For prevention of constipation, PEG or SPS is recommended instead of L.

Feeding difficulties in children with cerebral palsy: low-cost caregiver training in Dhaka, Bangladesh.

BACKGROUND: The majority of children with cerebral palsy have feeding difficulties, which, if not managed, result in stressful mealtimes, chronic malnutrition, respiratory disease, reduced quality of life for caregiver and child, and early death. In well-resourced countries, high- and low-cost medical interventions, ranging from gastrostomy tube feeding to caregiver training, are available. In resource-poor countries such as Bangladesh, the former is not viable and the latter is both scarce and its effectiveness not properly evaluated. The aim of this study was to evaluate the effectiveness of a low-cost, low-technology intervention to improve the feeding practices of carers of children with moderate-severe cerebral palsy and feeding difficulties in Bangladesh. METHODS: An opportunistic sample of 37 caregivers and their children aged 1-11 years were invited to a six-session training programme following an initial feeding assessment with brief advice. During home visits, pre- and post-measures of nutritional status, chest health and feeding-related stress were taken and feeding practices were observed. A control phase was evaluated for 20 of the participant pairs following initial assessment with advice, while awaiting full training. RESULTS: A minimum of four training sessions showed significant improvements in the children's respiratory health (P = 0.005), cooperation during mealtimes (P = 0.003) and overall mood (P < 0.001). Improvements in growth were inconsistent. Dramatic reductions were observed in caregiver stress (P < 0.001). A significant difference in the outcomes following advice only compared with advice plus training was also observed. CONCLUSIONS: In situations of poverty, compliance is restricted by lack of education, finances and time. Nonetheless, carers with minimal formal education, living in conditions of extreme poverty were able to change feeding practices after a short, low-cost training intervention, with highly positive consequences. The availability of affordable food supplementation for this population, however, requires urgent attention.

[Quality of life for wearers of a suprapubic or transurethral bladder catheter as lifelong permanent care]. / Lebensqualität bei Trägern eines suprapubischen oder transurethralen Harnblasenkatheters als lebenslange Dauerversorgung.

BACKGROUND: The insertion of a Foley catheter (FC) or a suprapubic catheter (SPC) in lifelong intent is an intervention with significant complications, comorbidities and impact on the further life that has not yet been analyzed. METHODOLOGY: The analysis was based on a validated assessment of catheter-related QoL with 25 items in 5 domains and applied to patients with a Foley or suprapubic catheter in lifelong indication and with the catheter in place for at least 3 months. Assessment data were enriched with information on the type and diameter of the catheter as well as demographic data. RESULTS: Questionnaires from 357 patients (260 male, 97 female, 193 with suprapubic catheter, 162 with Foley catheter, 2 no information) were included in the study. Patients with a Foley catheter were significantly older than patients with a suprapubic catheter (78.9 ± 11.1 years vs. 74.4. ± 12.6 years, p < 0.001). The average QoL score was 4.1 points on a scale from 1 (maximum impairment of QoL) to 5 (no impairment of QoL) indicating a moderately negative impact on QoL. Scores below the average were mainly driven and accompanied by a fear of urine leakage, urine odor, painful catheter changes and urinary infections increasing with age. Additionally, patients were worried about negative effects on their daily life activities due to the catheter. These worries seemed to be more pronounced in females with urinary incontinence, patients with a catheter size ≥ 18 Ch. and with an age of < 70 years. The type of catheter showed a greater impact on the QoL in females with suprapubic catheters when compared with males in contrast to patients with transurethral catheters. CONCLUSION: The results of the study provide further information for the medical clarification for patients and caregivers, having to decide between a lifelong catheter drainage or alternatives, such as provision of an aid or surgical recanalization.

[Comparison of catheter-associated quality of life in external urinary diversion: nephrostomy vs. suprapubic catheter]. / Vergleich der katheterassoziierten Lebensqualität bei externen Harnableitungen: Nephrostomie vs. suprapubischer Katheter.

INTRODUCTION: A percutaneous nephrostomy (PCN) affects the integrity of the patient due to the requirement of an external drainage bag and regular changes. The catheter-associated quality of life (QOL) was evaluated using a validated assessment and compared to similar patients with suprapubic bladder drainage. METHODS: A validated assessment analyzing catheter-related QOL for 5 domains and 25 individual items (first published by Mary Wilde) was completed during a catheter change appointment by patients who had their unilateral or bilateral PCN for a minimum of 3 months in life-long indication. RESULTS: In 66 patients (unilateral PCN: 42 patients), a moderate impairment of their catheter-related QOL was shown. The overall QOL score was median 4.0 on a scale of 0-5. This was rated lower-indicating a stronger impairment of QOL-than in patients with a suprapubic bladder catheter, who had a median score of 4.3. Significant differences were found related to the catheter type in the items "feeling of humiliation due to the PCN", "conflicts with the medical or nursing staff", "fear of painful catheter changes", "feeling ill", "being handicapped in activities of daily living" and "concern of not being able to do what one wants to do" and "fear of catheter leakages". The indication for the PCN due to a malignant or benign underlying disease was not associated with the catheter-related QOL. CONCLUSION: For the first time, the catheter-related QOL was found to be moderately impaired in patients with a PCN using a validated assessment. Affected individuals report feeling "ill" and "limited/disabled" in activities of daily living; thus, the surgical indication should be strict. Fear of painful catheter changes and of catheter leakages indicates the need of technically correct catheter changes.

[Are there benefits for catheter valves for catheter-associated quality of life? : Results of an investigation in 427 catheter wearers with life-long indication]. / Hat eine Ventilversorgung Vorteile bei der katheterassoziierten Lebensqualität? : Ergebnisse einer Untersuchung an 427 Katheterträgern in lebenslanger Indikation.

BACKGROUND: In urology, a subset of patients with lifelong urine drainage are fitted with a catheter valve. Data on catheter-related quality of life (crqol) in this subset of patients are missing. AIM: Clarification of the whether there are advantages for valve-aided catheters in comparison with continuous urine drainage in catheter wearers with a lifelong indication. METHODS: In all, 357 patients with a catheter with lifelong indication of continuous urine drainage from a previous study were compared with 70 valve-aided patients. The crqol was evaluated by a validated assessment with 25 items and five domains. RESULTS: There were statistically more patients with a suprapubic catheter than with a transurethral indwelling catheter (73.4 vs. 54.4%, p = 0.005), significantly more patients with bladder voiding dysfunction (73.5 vs. 52.6%, p = 0.003) and significantly more patients with small catheter sizes (p = 0.001). Crqol was altogether slightly impaired with a median score of 4.2 (no impairment indicated by 5 points) in valve-aided patients, but crqol was more impaired in valve-aided patients compared to patients with continuous drainage (4.4 points, n. s.). Some items demonstrated more problems dealing with urinary urge in valve-aided patients, but catheter-related pain was more often worse in patients with continuous drainage. CONCLUSION: There is no clear evidence for an advantage of a catheter valve over a continuous urine drainage system. Thus, the decision regarding a catheter-valve system must be made individually according to the indication and the preferences of the patient.

[Physicians' knowledge on cancer pain therapy : Comparison of palliative care and prehospital emergency physicians in training]. / Wissen verschiedener Arztgruppen über die Tumorschmerztherapie : Vergleich angehender Palliativ- und Notfallmediziner.

BACKGROUND: Palliative care needs a high level of expertise. In particular, there are some potential difficulties in the treatment of patients with the symptom cancer pain (for example lack of education). In Germany, various physicians are involved in cancer pain treatment but in general palliative care patients are treated by a physician who is educated in palliative medicine. In special circumstances prehospital emergency physicians and other physicians are involved in therapy decisions in palliative care patients as well. The authors surveyed different groups of physicians in Germany about their specific knowledge of cancer pain management. MATERIAL AND METHODS: A self-designed, standardized questionnaire (50 items) was given to palliative physicians in training (PP). The survey asked prospectively for knowledge on the World Health Organization (WHO) step ladder of cancer pain therapy. The results were retrolectively compared with an earlier investigation with the same background (emergency physicians in training EP). RESULTS: There was a 99.5% response rate with a total of 654 respondents (PP 185, EP 469) and 461 (70.5%) of the respondents had knowledge of the WHO step ladder for the treatment of cancer pain [PP 164/185 (88.6%), EP 297/469 (63.3%), PP versus EP p < 0.001)]. The correct numbers of therapeutic levels were known by 361/461 participants [PP 151/164 (92.1%), EP 210/297 (70.7%), p < 0.001].The EPs with a professional experience less than 5 years answered statistically significantly more questions correctly (p = 0.004). Concerning the defined parameters knowledge and professional experience, there was no statistically significant difference in the group of PP. CONCLUSIONS: The results of this study verified that the highest knowledge scores were achieved by PPs and overall, the knowledge scores showed an improvement in comparison to previous investigations. In recent years there seems to have been an improvement in education on pain treatment,for example during medical school. Whether this also leads to an improvement of patient care and the relevance of these data for the clinical practice needs to be investigated in further studies.

Patient state index vs bispectral index as measures of the electroencephalographic effects of propofol.

BACKGROUND: The patient state index (PSI) and the bispectral index (BIS) quantify anaesthetic depth based on the EEG using different algorithms. We compared both indices with regard to the prediction of the depth of propofol anaesthesia. METHODS: In 17 patients, propofol was infused until burst suppression occurred and stopped thereafter until BIS recovered to values above 60. This was repeated; afterwards, patients were intubated, for subsequent surgery. Without surgical stimulus, PSI and BIS were measured simultaneously and compared with the estimated effect-site concentrations of propofol. These were derived from simultaneous pharmacokinetic and -dynamic modelling in an individual two-stage and a population-based NONMEM approach. RESULTS: A close sigmoid relationship was observed between the propofol effect-site concentration and both PSI [coefficient of determination rho(2)=0.91 (sd 0.05)] and BIS [rho(2)=0.92 (0.03)], which was significantly steeper for PSI [gamma=2.2 (0.6)] than for BIS [gamma=1.8 (0.4)], and reached significantly lower values for PSI [E(max)=0.3 (1.1)] than for BIS [E(max)=5.3 (6.7)] at maximal propofol concentrations. A significantly smaller k(e0) was obtained for PSI [0.09 (0.03) min(-1)] compared with BIS [0.10 (0.02) min(-1)]. PSI and BIS correlated significantly with each other (rho(2)=0.866) and predicted propofol effect-site concentration with a comparable probability [P(K)=0.87 (0.05) and 0.86 (0.05), respectively]. NONMEM revealed E(0)=89.3 and 92.3, E(max)=1.9 and 8.6, C(e50)=1.38 and 1.92 microg ml(-1), gamma=1.6 and 1.48, and k(e0)=0.103 and 0.131 min(-1) as typical values for PSI and BIS, respectively. CONCLUSIONS: The PSI and the BIS monitors performed equally well in predicting depth of propofol anaesthesia. However, PSI was lower than BIS by approximately 10-15 points at high propofol concentrations.

[Modafinil for the treatment of cancer-related fatigue : an intervention study]. / Modafinil zur behandlung der tumorfatigue : eine interventionsstudie.

AIM: the authors conducted an open-label investigation examining the effects of modafinil in reducing fatigue in patients with cancer, undergoing cancer treatment, and receiving opioid therapy. METHODS: after approval by the local Ethics Committee and informed consent cancer patients who reported fatigue - defined as persistent tiredness interfering with usual functioning - were enrolled in the study. Once daily, patients received 100 mg open-label modafinil. The Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), and a visual analogue scale (VAS, 0-10) were performed at baseline (t1), day 7 (t2), and day 28 (t3). Further assessment comprised the d2 Test of Attention (d2), the Hamilton Depression Scale (HAMD), the Eastern Cooperative Oncology Group-Score (ECOG), side effects, and patients' satisfaction with modafinil treatment. RESULTS: of the 37 patients who were enrolled, 29 completed all assessments in the study. Modafinil had a significant effect on the FSS (t1 44.6+/-12.2, t2 39+/-12.4, t3 35.3+/-13.8 (p=0.015), on the VAS (t1 6+/-3.1), t2 4.5+/-2.8, t3 3.7+/-2.8 (p=0.005), and an insignificant effect on d2 parameters of neurophysiological functioning and ESS. No differences were seen for ECOG and patients' satisfaction. No severe adverse effects were detected. CONCLUSION: modafinil improved alertness and cognitive skills in patients receiving cancer pain treatment by enhancing vigilance and cognitive performance. Although confirmation of this preliminary result is needed, these findings suggest that modafinil may improve quality of life in this patient population. However, in Germany the use of modafinil for fatigue is off-label and careful assessment of fatigue is needed prior to treatment. Randomized controlled trials are needed to confirm this evidence.