[Opioids and driving ability -- a problem unsolved?].
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Biomedical subjects
Publications and source records attributed to R Sabatowski.
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In a regional pain management network in Cologne, sponsored by the German Ministry of Health, structures of outpatient pain treatment in general practice and the adherence to pain management guidelines were examined. The 3-year project was divided into a 1-year observational period to analyze the present state of outpatient pain management followed by a 2-year period of interventions such as consultations and educational training programs in pain treatment. Eighty physicians with different specializations working in general practice took part in the network. The knowledge of and adherence to the guidelines for the treatment of headache and cancer pain were examined by questionnaire surveys and six simulated patient cases. These investigations were performed yearly from 1997 to 2000. The adherence to the guidelines for the treatment of headache and cancer pain by the physicians participating in the network was low. The levels achieved for simulated cases of headache were higher than for cancer pain. The results of simulated patient cases from the beginning and the end of the project were available for comparison for 28 physicians. Evaluation of the physicians' assessment of the simulated patient cases increased only fractionally and was not significant in headache patients (median change of 0.67) and cancer pain patients (median change of 0.17). The network interventions resulted in a slight improvement in the knowledge of and attitudes to the treatment of headache and cancer pain as judged by simulated patient cases. This improvement, however, did not reach statistical significance. The small number of physicians answering at the beginning and at the end of the project made it difficult to draw a general conclusion on whether the interventions had led to an improvement in outpatient pain management in a larger group of physicians.
Most potent opioid analgesics available in Germany have been investigated for use in postoperative patient-controlled analgesia (PCA). To conclude an older comparative series, it was the aim of the present study to define analgesic potency, side effects and patient acceptance of hydromorphone and its interaction with the non-opioid analgesic metamizole. A total of 120 patients recovering from elective abdominal or orthopaedic surgery, performed under standardised general anaesthesia, were randomised into 3 double-blind treatment groups to receive intravenous PCA demand doses of hydromorphone 283 micrograms (low dose, LD), 566 micrograms (high dose, HD) or a combination of hydromorphone 283 micrograms and metamizole 50 mg (low dose hydromorphone + metamizole, LM). Demand-independent low-dose background infusions were added to deliver hydromorphone at 67.9 micrograms/h in all groups, with additional metamizole at 12 mg/h in group LM. Lockout times were set to 2 min. After an average observation time of 24.5 +/- 2.6 h (mean, SD) since start of PCA, cumulative PCA hydromorphone doses in groups LD, HD and LM were 7.8 +/- 3.3, 12.1 +/- 4.8 and 7.5 +/- 2.0 mg, respectively, with the well known large inter-individual variability in all groups. Although hydromorphone consumption was significantly higher in group HD, self-reported pain intensities (VAS, retrospective pain scores) were quite comparable between the groups. Low dose, PCA bolus-linked metamizole did not significantly reduce hydromorphone consumption nor improve patient acceptance. Side-effects were typical for potent postoperative opioids, but never required special treatment; haemodynamic or respiratory complications were not observed in any patient. It can be concluded by comparison with other PCA opioid investigations performed under the same study protocol that hydromorphone is about 3-4 times as potent an analgesic as morphine under the conditions of intravenous postoperative PCA. Due to a favourable patient acceptance, hydromorphone can be recommended as a suitable alternative to other opioids for the treatment of postoperative pain.
The German regulations for opioid prescriptions have been changed in February 1998. The regulations have been made much more easier and should therefore have improved the pain management in Germany. We investigated the knowledge of the WHO analgesic ladder and how they have been followed in a nation-wide survey among physicians not specialised in pain management. Only 9% of the questionnaires were returned. Although the majority of the physicians (93%) reported knowledge about the WHO recommendations for the treatment of cancer pain, more than 15% of the participating physicians rated transdermal fentanyl as a weak opioid or even as a non-opioid. A negative pain management index in 15% of the patients gave evidence of poor quality in pain management. The majority of patients (84%) did not receive immediate release analgesics for the treatment of breakthrough pain. Continuous medical education is still necessary before a further alleviation of regulations will help to reduce the undertreatment of patients suffering from cancer pain in Germany.
In April 1999 altogether 114 inpatient units providing palliative care (50 palliative care units, 64 inpatient-hospices) offered a total of 989 beds. Compared to 1993 this has been an increase of 256%, compared to 1997 of 60%. The number of available beds, compared to 1997, increased markedly (58%), with a availability of 12 beds per one million residents. However, there are still major deficits: the distribution of the units is very irregular and the number of available beds is still to low, compared to the estimated need of 50 inpatient beds per one million residents. The quality of palliative care shows significant deficits (e. g. the availability of nursing staff, cooperation with pain clinics, standardised documentation, education). Differences between palliative care wards and hospices were huge. According to the definition of the German Society for Palliative Care, a palliative care ward should provide a ratio of at least 1.4 nursing staff per bed, however, only 18% of the palliative care units fulfil this definition. Only few hospices and half of the palliative care units worked in close cooperation with pain clinics. Despite a significant increase in units and inpatient beds providing palliative care, there still is a major deficit in the overall number of beds and the quality of palliative care.
INTRODUCTION: Even in the last century cannabis was used in the treatment of chronic pain. The main active component of cannabis Delta-9-Tetrahydrocannabinol (THC) has been increasingly used in the treatment of nausea, vomiting, loss of appetite and depression. It is also recommended in the treatment of chronic pain. We present our first experiences with THC in the treatment of patients with chronic pain. METHODS: All patients treated with THC in the period from February 1998 until January 2000 were evaluated. Pain relief and side effects of THC were examined retrospectively. RESULTS: In the period of investigation 6 patients had been treated with THC because of chronic pain. Dosages between 5 and 20 mg/d had been used. A sufficient pain relief had been achieved in three patients. The other three suffered from intolerable side effects such as nausea, dizziness and sedation without a reduction of pain intensity. In these cases the treatment was continued with other analgesics. CONCLUSION: This retrospective evaluation of 6 case reports of patients treated with THC showed large individual differences in the effectiveness of THC in pain management. Prospective studies are necessary to evaluate the importance THC in the treatment of chronic pain.
Patients with moderate to severe cancer pain and insufficient pain relief from nonopioid analgesics were treated with slow-release tramadol for initial dose finding and as a long-term treatment. Immediate-release tramadol was provided for the treatment of breakthrough pain and a standard nonopioid analgesic (1000 mg naproxen daily) was given as suggested for step 2 of the WHO analgesic ladder. Ninety of 146 patients (62%) completed the 6-week trial period. Drop-outs were due to adverse events (20%), inadequate pain relief (9%), or both (2.5%), death due to the underlying disease (4%), low patient compliance (2%) or other reasons. Average and maximal pain intensity decreased from day 1 to day 4. The number of patients with good and complete pain relief increased from 43% after week 1 to 71% after week 6 with maximum daily doses of tramadol up to 650 mg. However, 70% of the patients still needed less than 400 mg tramadol per day in week 6. Most patients (86%) experienced adverse events during the study period. Some common side effects of opioids, such as fatigue, dizziness, and constipation, decreased in frequency over the 6 weeks. The frequency of other adverse events such as nausea, vomiting and sweating did not change. Slow-release tramadol provided fast and efficient pain relief in almost two-thirds of patients both during initial dose finding and during long-term treatment, improving treatment options in step 2 of the WHO analgesic ladder.
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BACKGROUND: Previous studies failed to demonstrate any benefit from prophylaxis with fresh frozen plasma (FFP) after cardiopulmonary bypass (CPB). The results, however, were limited by either retrospective study design or use of FFP in subtherapeutic doses (2-3 units). The authors evaluated whether a therapeutic dose (15 ml/kg) of FFP reduces blood loss and transfusion requirements in elective coronary artery bypass surgery. The risks of multiple allogeneic blood donor exposure were circumvented by using autologous plasma. METHODS: Sixty adult patients scheduled for elective primary coronary artery bypass grafting were randomized to receive, after CPB, an intravenous infusion of 15 ml/kg of either autologous FFP (30 patients) or 6% hydroxyethyl starch 450/0.7 (HES; 30 patients). Autologous plasma was obtained by platelet-poor plasmapheresis several weeks before surgery. Perioperative blood transfusions were administered per protocol. Postoperative blood loss was defined as the chest tube drainage during the first 24 h after surgery. RESULTS: The data from 56 patients (FFP group, 27 patients; HES group, 29 patients) who completed the study according to protocol were analyzed. Median postoperative blood loss was 630 ml (range, 450-1,840 ml) and 830 ml (range, 340-1,980 ml) in the FFP and HES groups, respectively (P = 0.08). Both postoperative (0-24 h) and total perioperative erythrocyte transfusion requirements did not differ significantly between the groups (P = 0.32 and 0.14, respectively). CONCLUSION: The prophylactic administration of a therapeutic dose (15 ml/kg) of autologous FFP after CPB failed to reduce blood loss and transfusion requirements in patients undergoing uncomplicated, elective, primary coronary artery bypass surgery.
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.
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.
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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.
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.
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.
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.
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.