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Biomedical subjects

L Radbruch

Publications and source records attributed to L Radbruch.

At least 37 records · Page 2Linked to original sources
PubMed2001

Transdermal fentanyl for the management of cancer pain: a survey of 1005 patients.

Transdermal fentanyl was released in Germany in 1995. From October 1996 to February 1998 transdermal treatment was documented for 1005 patients (506 men and 499 women with a mean age of 60 years, range 20-92 years) with chronic pain in an open survey including 290 physicians from hospitals and general practitioners throughout Germany. Most patients suffered from cancer pain and only 11 patients had chronic pain from non-malignant disease. Physicians were asked to complete a questionnaire for patients treated with transdermal fentanyl on initiation of therapy (day 0), and days 3, 6, 18, 30 thereafter, followed by monthly follow-up intervals. Patients were asked to complete a pain diary. Transdermal therapy was documented from day 0 for 824 patients, while 181 patients had been treated with transdermal fentanyl before admission in the survey. Most of the other 824 patients had been treated with other step 3 opioids (55% of the patients) or step 2 opioids (23%) before conversion to transdermal fentanyl, whereas 8% had been treated only with non-opioids and 14% had received analgesics only as required or not at all before initiation of transdermal therapy. The most important reasons for switching to transdermal opioid therapy were insufficient pain relief with the previous medication followed by a variety of gastrointestinal symptoms impeding oral analgesic therapy. Initial fentanyl doses ranged from 0.6 to 9.6 mg/day (25 to 400 microg/h) with a median of 1.2 mg/day (50 microg/h). Median doses slowly increased throughout the observation period to 2.4 mg/day (100 microg/h) after 4 months of treatment. Most patients continued transdermal therapy until the time of death (47% of patients). Other reasons for discontinuation were inadequate pain relief (10%), pain relief with other analgesic regimens (10%), other symptoms than pain (5%), rejection of transdermal therapy by the patient (6%) or miscellaneous (16%). Adverse events were documented as the reason for discontinuation of transdermal therapy in 49 patients (5%). Dyspnoea was documented for seven patients as the reason for discontinuation. One of these patients, as well as another patient with an episode of apnoea, had to be treated with artificial respiration for several hours, but both patients recovered without sequelae. Transdermal therapy with fentanyl was safe and efficient in this national survey. Transdermal fentanyl can be recommended for treatment of moderate to severe cancer pain and probably may even be used as a first-line drug on step 3 of the World Health Organization recommendations in selected patient groups.

Administration, Cutaneous↗
PubMed2000

[Morphine dose and side effects: a comparison of older and younger patients with tumor pain].

UNLABELLED: BACKGROUND AND GOAL OF STUDY: Older patients are said to be more sensitive to analgesics and to have a higher risk of side effects due to pharmacokinetic changes developing with old age. On account of this many elderly patients with cancer pain are denied adequate analgesic treatment. We compared efficacy and side effects of cancer pain management in different age groups. METHODS: From 1994 to April 1996 577 cancer patients were treated in our pain clinic according to WHO-Guidelines. Efficacy and side effects were evaluated for 508 patients (< 65 years = G1: 323 patients, 65-74 years = G2: 127 patients, > 74 years = G3: 58 patients) with a computerised documentation system. RESULTS: 508 patients were treated on 42,123 days and revisited on 5572 controls. 30 patients were treated longer than 1 year (G1 21 patients, G2 6 patients, G3 3 patients). 143 patients were treated until death. 286 patients were treated on 19,448 days with oral morphine. (G1: 1712 days; G2: 3645 days; G3: 2364 days). Geriatric patients (G3) received significantly higher doses of morphine than younger patients. Adjuvant drugs were given on 81% of treatment days (G1 84%, G2 75%, G3 75%). Incidence and intensity of side effects were not increased in older patients with the exception of urinary disorders. CONCLUSIONS: Geriatric patients with cancer pain can be treated as effectively according to WHO-Guidelines as younger patients. In our study patients in the old age group received significantly higher doses of oral morphine. When analgesic drugs are titrated according to individual needs, side effects are not more frequent or severe than in younger patients.

Administration, Oral↗
PubMed2000

[MIDOS--validation of a minimal documentation system for palliative medicine].

INTRODUCTION: Repeated assessment of pain and other symptoms is required for quality assurance in palliative care. However, physical and cognitive impairment of the patients may impede the use of standardized questionnaires and documentation systems in palliative care setting. We developed a minimal documentation system (MIDOS) for the specific requirements in this setting. METHODS: The German versions of the Brief Pain Inventory (BPI) and the quality of life questionnaire SF-12 were completed for all patients admitted to the palliative care unit. Cognitive impairment was assessed with the Mini Mental State Examination (MMSE). With admission as well as on subsequent consultations patients self-assessed average and maximum pain intensity on numeric rating scales and the intensity of drowsiness, nausea, constipation, dyspnea, weakness, anxiety and well-being on verbal categorical scales. RESULTS: From August 1998 to June 1999 128 patients were documented consecutively. Fifty-nine percent of these patients were treated with WHO-step 3 opioids. Cognitive impairment (MMSE<24) was present in 37% of the patients. Self-assessment with MIDOS was possible for 114 patients at the time of admission, and for 108 patients at the end of therapy. Pain, drowsiness and weakness were documented by most patients, whereas the other symptoms were reported less frequently. DISCUSSION: Factor analysis showed one factor for pain and two factors for the other symptoms. The pain sum score of MIDOS correlated with the factors of the BPI, the symptom sum score of MIDOS correlated with the factors of the BPI and the mental sum score of the SF-12, though on a lower level. MIDOS sum scores showed good pain relief and symptom control for patients discharged home or to other services, whereas the symptom sum score gave an indication of the deterioration in the terminal phase for those patients who died during in-patient treatment. Test-retest stability was good for a subgroup of patients with stable opioid doses. CONCLUSIONS: We conclude that MIDOS is a valid instrument for self-assessment of the patient's symptoms and may be used to monitor the efficacy of symptom management.

English Abstract↗
PubMed2000

[MIDOS--an electronic database for the palliative care unit].

INTRODUCTION: A minimal documentation system (MIDOS) has been developed for self-assessment of pain and other symptoms by the patients on palliative care units. To decrease the administrative burden and thereby increase the acceptance of the system an electronic database was developed to facilitate data entry and documentation. SYSTEM: The database is based on Microsoft Access. Screen masks are used for navigation and data entry. According to the type of data items may be chosen in checklists or pull-down menus or entered as free text. The main menu documents personal data from the patient. Submenus can be reached from the main screen mask. Submenus included are the core documentation of the working group of the German Ministry of Health, the German versions of the Brief Pain Inventory, the quality of life questionnaire SF-12 and the Mini Mental State Examination for assessment of cognitive impairment. Data from these instruments may be assessed repeatedly for the same patient. Documentation of follow-up consultations include self-assessment of pain and other symptoms by the patient (MIDOS) and the analgesic regimen. These informations should be documented for each consultation. CONCLUSION: This data base was used in two trials on the palliative care unit of the university of Cologne, confirming data safety and convenience of the programme. We recommend the use of this data base in combination with MIDOS and the core documentation for routine assessment on the palliative care ward.

English Abstract↗
PubMed2000

Treatment of severe low back pain with opioids during pregnancy in a patient with incomplete tetraplegia.

We report a case of severe low back pain during pregnancy in a woman with incomplete tetraplegia due to viral myelitis. The pain was interpreted as a radiculopathy in the presence of multiple herniated discs. Surgical intervention was not indicated and physiotherapy failed; therefore, a symptomatic drug treatment with oral analgesics was initiated. To minimise the total daily opioid dosage and the potential risk of a neonatal withdrawal syndrome due to opioids, the route of administration was changed from oral to epidural. Adequate pain relief was maintained with this regimen until caesarean section was necessary. The neonatal withdrawal symptoms after delivery were mild. Residual pain slowly diminished after delivery and the patient was able to discontinue opioid therapy. The aetiology of low back pain remains unclear and may be multifactorial.

Adult↗
PubMed2000

[Emergency pain treatment--ambulatory intravenous morphine titration in a patient with cancer pain].

Even when the guidelines for cancer pain management are followed, acute severe pain requiring immediate treatment will occur in some patients. Titration with intravenous morphine may provide fast and efficient pain relief and give an indication of the amount of opioid necessary for continuous treatment. In cooperation with a general practitioner we performed an intravenous morphine titration in a patient with severe cancer pain at home. Adequate analgesia was reached with 20 mg intravenous morphine. Blood pressure, cardiac frequency and oxygen saturation did not change. No side effects were reported during the titration, and the previous regimen with tramadol 150 mg per day was switched to slow release morphine 300 mg per day. This medication was prescribed by the general practitioner and provided good pain relief until the patient died two weeks later. We conclude that intravenous morphine titration may be performed even in cancer patients at home, adequate monitoring, however, should be available.

Aged↗
PubMed2000

Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine.

Constipation and the use of laxatives were investigated in patients with chronic cancer pain treated with oral morphine and transdermal fentanyl in an open sequential trial. Forty-six patients were treated with slow-release morphine 30-1000 mg/day for 6 days and 39 of these patients were switched to transdermal fentanyl 0.6-9.6 mg/day with a conversion ratio of 100:1. Median fentanyl doses increased from 1.2 to 3.0 mg/day throughout the 30-day transdermal treatment period. Twenty-three patients completed the study. Two patients died from the basic disease while treated with transdermal fentanyl, 12 patients were excluded for various reasons, and not enough data for evaluation were available for two patients. Mean pain intensity decreased slightly after conversion although the number of patients with breakthrough pain or requiring immediate-release morphine as a rescue medication was higher with transdermal fentanyl. The number of patients with bowel movements did not change after the opioid switch but the number of patients taking laxatives was reduced significantly from 78-87% of the patients per treatment day (morphine) to 22-48% (fentanyl). Lactulose was used mainly and was reduced most drastically, but other laxatives were also used less frequently. In this study transdermal fentanyl was associated with a significantly lower use of laxatives compared to oral morphine. The difference in the degree of constipation between the two analgesic regimens should be confirmed in a randomized double-blind study that takes into account both constipation and use of laxatives.

Administration, Cutaneous↗
PubMed2000

Cognitive impairment and its influence on pain and symptom assessment in a palliative care unit: development of a Minimal Documentation System.

Symptom assessment in the palliative care unit must consider the reduced physical and mental status of the patients. Standardized instruments are often not completed by patients with cognitive impairment. We tried to combine minimal burden for patients and staff with sufficient information content in a Minimal Documentation System (MIDOS) for pain and symptom assessment in palliative care patients. From January to July 1998, 108 patients (123 consecutive admissions) with a mean age of 63 years (range 32-87 years) were admitted to the palliative care unit. Pain was reported as the reason for admission in 70% of the patients, and 71% were treated with opioids. Using a cut-off point of 20/21, 35% of the patients were impaired in the Mini Mental State Examination (MMSE). The number of missing values in the Brief Pain Inventory (BPI) and the quality-of-life questionnaire SF-12 correlated highly with each other and with the MMSE sum score, but not with the summary scores of BPI or SF-12. Only 31 patients completed the SF-12 quality-of-life questionnaire. Age was not correlated to MMSE scores, and neither were opioid doses for 26 patients with slow-release oral morphine or for 20 patients with transdermal fentanyl. Only a minority of patients was able to use the numerical scale for symptoms other than pain, though most patients were able to score symptom intensity on the verbal categorical scale. Pain and symptom assessments were performed by the physician for 17% of the patients at admission, and for 16% of the follow-up controls because self-assessment was not possible. In this study, cognitive impairment prevented symptom assessment with longer and more complicated instruments such as the SF-12 in a large number of the patients admitted to the palliative care unit. Assessment instruments for patients with advanced disease must provide simple categorical scales and the possibility of being administered by interview.

Adult↗
PubMed2000

Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl.

Transdermal delivery allows continuous systemic application of opioids through the intact skin. This review analyses the pharmacokinetic properties of transdermal opioid administration in the context of clinical experience, with a focus on fentanyl. A transdermal therapeutic system (TTS) for fentanyl has been developed. The amount of fentanyl released is proportional to the surface area of the TTS, which is available in different sizes. After the first application of a TTS, a fentanyl depot concentrates in the upper skin layers and it takes several hours until clinical effects are observed. The time from application to minimal effective and maximum serum concentrations is 1.2 to 40 hours and 12 to 48 hours, respectively. Steady state is reached on the third day, and can be maintained as long as patches are renewed. Within each 72-hour period, serum concentrations decrease gradually over the second and third days. When a TTS is removed, fentanyl continues to be absorbed into the systemic circulation from the cutaneous depot. The terminal half-life for TTS fentanyl is approximately 13 to 25 hours. The interindividual variability of serum concentrations, partly caused by different clearance rates, is markedly larger than the intraindividual variability. The effectiveness of TTS fentanyl was first demonstrated in acute postoperative pain. However, the slow pharmacokinetics and large variability of TTS fentanyl, together with the relatively short duration of postoperative pain, precluded adequate dose finding and led to inadequate pain relief or, especially, a high incidence of respiratory depression; such use is now contraindicated. Conversely, in cancer pain, TTS fentanyl offers an interesting alternative to oral morphine, and its effectiveness and tolerability in this indication has been demonstrated by a number of trials. Its usefulness in chronic pain of nonmalignant origin remains to be confirmed in controlled trials. In general, TTS fentanyl produces the same adverse effects as other opioids, mainly sedation, nausea, vomiting and constipation. In comparison with oral morphine, TTS fentanyl causes fewer gastrointestinal adverse events. The risk of hypoventilation is comparatively low in cancer patients. Sufentanil and buprenorphine may also be suitable for transdermal delivery, but clinical results are not yet available. Transdermal morphine is only useful if applied to de-epithelialised skin. However, iontophoresis may allow transdermal administration of opioids, including morphine, with a rapid achievement of steady state concentrations and the ability to adjust delivery rates. This would be beneficial for acute and/or breakthrough pain, and initial clinical trials are in progress.

Administration, Cutaneous↗
PubMed2000

[Deficits in the treatment of chronic pain (I)].

Pain management by general practitioners often is inadequate. Guidelines for pain management are either not observed or not known at all. Opioids are not prescribed adequately. Differential diagnoses influencing the therapeutic regimen such as drug-induced headache are not sufficiently known. Monotherapies with analgesic drugs are enforced for patients with chronic lower back pain in spite of low efficacy. Improving pain management can be difficult for the general practitioner having no special knowledges or support from pain specialists. However, the general practitioner should remain the patient-coordinator for the patient with chronic pain. Networks with general practitioners and specialised units in the hospital may offer possibilities for improvement of pain management deficits.

Analgesics↗
PubMed2000

[Deficits in the treatment of chronic pain. 2. Possibilities for improvement through the Pain Therapy Ambulant Network (STAN)].

In a regional pain management network in Cologne, the pain clinic of the department of anaesthesiology and the departments of psychosomatic medicine and of informatics, statistics and epidemiology have been cooperating with the regional board of physicians and more than 80 general practitioners since 1996. The program is sponsored by the German Ministry of Health. In this network, guidelines for the management of chronic pain have been implemented for outpatient care in the last three years. Results from the first year confirm the high level of distress of patients with chronic pain. Consultation and education offered by the coordinating office and in training courses were accepted by the practitioners in variable degrees. Some physicians requested consultations frequently while including only a few patients in the study documentation, while other physicians requested consultations rarely and assessed many patients. Participating physicians were also asked to provide analgesic regimens for constructed case reports with chronic headache or cancer pain. The evaluation of these prescriptions showed poor adherence to analgesic guidelines.

Ambulatory Care↗
PubMed1999

[WHO recommendations for treatment of tumor pain. Development of an evaluation system].

AIM OF THE STUDY: Evaluation of the observance of the World Health Organization guidelines for cancer pain management is a prerequisite for further research into the effectiveness and acceptability of the guidelines. METHODS: In a nationwide survey 172 physicians in pain management and oncological units documented transdermal therapy with fentanyl. From October 1996 to May 1997, 591 patients were included. A total of 148 patients had already received transdermal fentanyl before inclusion in the survey, and no data on previous analgesic management were available for 7 patients. For 436 patients analgesic therapy before initiation of transdermal fentanyl was evaluated. The last analgesic regimen documented by the treating physician was rated by three physicians from our pain clinic independently of each other. A rating system with four items (potency of analgesic according to the analgesic ladder of the WHO guidelines, prescription of a rescue medication, combination of nonopioids with opioids, inadequate combinations of analgesics) and a global rating (the analgesic regimen is considered adequate, sufficient or inadequate) was used. RESULTS: Good agreement was reached for classification according to the analgesic ladder, prescription of rescue medication and for inadequate drug combinations. The ratings on combinations with nonopioids showed more differences. The scores for the global assessment showed a wide difference between raters, with agreement on the same score for only 36.2% (raters 1 and 3), 36.7% (raters 2 and 3) and 55.5% of the patients (raters 1 and 3). CONCLUSIONS: A global assessment score is not useful for evaluation of guideline acceptance. A more differentiated scoring system was developed for further studies that includes the analgesic ladder and other aspects of the WHO guidelines in a 10-point score.

English Abstract↗
PubMed1999

[Switching opioids to transdermal fentanyl in a clinical setting].

INTRODUCTION: The use of transdermal fentanyl is gaining in importance in the management of cancer pain. We describe the reasons for switching opioid medication to transdermal fentanyl in a pain management unit. METHODS: Case records of patients treated with transdermal fentanyl in our pain clinic were evaluated retrospectively. Conversion ratios were calculated from the opioid dosage before and after conversion. Pain intensities were assessed on a numeric rating scale (NRS 0: no pain, 10: worst pain imaginable). RESULTS: From October 1995 to December 1997 101 patients received transdermal fentanyl. Thirty-six patients had been treated with transdermal fentanyl before admission to our pain clinic, and relevant information was missing for one patient, so 64 patients were evaluated. Opioid therapy was switched to transdermal fentanyl during in-patient treatment for 53 patients and during out-patient treatment for 11 patients. Before conversion patients were treated with slow-release morphine (48%), immediate-release morphine (17%), buprenorphine (11%), tramadol (11%), levomethadone (5%), tilidine/naloxone (5%) and piritramid (3%). Reasons for opioid rotation were inadequate pain relief ( 33%), the patients' wish to reduce oral medication (20%), gastrointestinal side effects such as nausea (31%), vomiting (13%) and constipation (19%), dysphagia (27%) or others. Reduction of side effects was reported by 10 of 19 patients. In 12 of 21 patients, in whom the medication was switched because of inadequate pain relief, a reduction in pain intensity was reported. DISCUSSION: Conversion to transdermal therapy may readjust the balance between opioid analgesia and side effects. The opioid switch resulted in more pain relief or fewer side effects in half of the patients. A proposed equianalgesic conversion ratio between 70:1 and 100:1 from oral slow-release morphine to transdermal fentanyl can be confirmed by our data. Conversion rates from other opioids to transdermal fentanyl are suggested.

English Abstract↗
PubMed1999

Temporal presentation of chronic cancer pain: transitory pains on admission to a multidisciplinary pain clinic.

Transitory flares of pain are well-recognized events in both untreated and treated patients suffering from chronic cancer pain. For the purpose of this survey, we refer to transitory pain (TP) as any event subjectively characterized by transience and pain intensity over a baseline pain. In Part I, TP was reported by 243 (39%) of 613 consecutive cancer pain patients. Gender, age, tumor site, stage, and therapy were not related to the presence of TP. Neuropathic baseline pain was associated with a higher prevalence of TP (P < 0.0001). TP was somatic in 39%, visceral in 22%, and neuropathic in 36% of patients. TP intensity was severe or worse in 92% of patients. Neuropathic TP was briefer and occurred more frequently than nociceptive TP. In Part II, further features of TP were surveyed in 55 patients. Patients reported spontaneous occurrence of TP (40%), a relationship to movement (36%), to the analgesic regimen (35%), to coughing (11%), and to various other factors (18%). Only half of the movement-related TP were predictable. Rescue medication was at least partially effective in 75% of patients. Change in position, rest, diversion, and physiotherapy were commonly employed to alleviate TP. This survey outlined a framework to characterize TP that may prove useful to clarify the definition, pathophysiology, and prevalence of these pains.

Adolescent↗
PubMed1999

High-dose tramadol in comparison to low-dose morphine for cancer pain relief.

Cancer pain treatment following the World Health Organization guidelines is effective and feasible. However, the evidence supporting the use of opioids for mild to moderate pain on the second step of the analgesic ladder is widely discussed. The present evaluation compares the efficacy and safety of high doses of oral tramadol (> or = 300 mg/d) with low doses of oral morphine (< or = 60 mg/d). Patients were included in this nonblinded and nonrandomized study if the combination of a nonopioid analgesic and up to 250 mg/d of oral tramadol was inadequate. 810 patients received oral tramadol for a total of 23,497 days, and 848 patients received oral morphine for a total of 24,695 days. The average dose of tramadol was 428 +/- 101 mg/d (range 300-600 mg/d); the average dose of morphine was 42 +/- 13 mg/d (range 10-60 mg/d). Additional nonopioid analgesics were given on more than 95% of days. Antiemetics, laxatives, neuroleptics, and steroids were prescribed significantly more frequently in the morphine group; the use of other adjuvants was similar in both groups. The mean pain intensity on a 0-100 numerical rating scale (NRS) was 27 +/- 21 (95% CI 26-29) in the tramadol and 26 +/- 20 (95% CI 24-27) in the morphine group (NS). The analgesic efficacy was good in 74% and 78%, satisfactory in 10% and 7%, and inadequate in 16% and 15% of patients receiving tramadol and morphine, respectively (NS). Constipation, neuropsychological symptoms, and pruritus were observed significantly more frequently with low-dose morphine; other symptoms had similar frequencies in both groups. These data suggest that tramadol can be used for the treatment of cancer pain, when nonopioids alone are not effective. High doses of tramadol are effective and safe.

Aged↗
PubMed1999

Validation of the German version of the Brief Pain Inventory.

The Brief Pain Inventory is a comprehensive instrument for pain assessment and has been validated in several languages. A validated German version was not available until now. From March to May 1995 all outpatients of the pain clinic of the Department of Anesthesiology completed a questionnaire with the German versions of the Brief Pain Inventory (BPI) and the SF-36 quality-of-life questionnaire. The BPI was repeated after the consultation. The physician assessed the performance status score of the Eastern Cooperative Oncology Group (ECOG). The questionnaire was completed by 151 patients. Forty-two patients were excluded from evaluation for methodological reasons, so 109 patients were evaluated. As in the original version of the BPI, factor analysis showed a common factor for pain intensity and a second factor for pain-related interference with function. The comparative fit index of 0.86 confirmed this model. Responses before and after consultation correlated closely for the sum scores of the pain intensity items (Perarson correlation r = 0.976) as well as for the interference with function items (r = 0.974). Pain intensity in the BPI correlated with bodily pain in the SF-36 (r = 0.585). Sum scores of the pain interference items were higher in patients with deteriorated ECOG performance status, whereas sum scores of the intensity items were not changed. Validity and reliability of the German BPI were comparable to the original version. The BPI may be advantageous for palliative care patients, as it places only a small burden on the patient and offers easy criteria for evaluation. However, further research is needed to differentiate the impact of pain-related and disease-related interference with function on the BPI, and to find an algorithm for the evaluation of the BPI when values are missing.

Adult↗