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Biomedical subjects

R Sabatowski

Publications and source records attributed to R Sabatowski.

At least 19 recordsLinked to original sources

[Oral controlled-release oxycodone for the treatment of chronic pain. Data from 4196 patients].

Oral controlled-release oxycodone has been available for the treatment of chronic pain in Germany since 1998. Controlled trials have shown good clinical efficacy and tolerability. This survey reports results from six open prospective multicenter trials. In these trials 4196 patients suffering from cancer pain and non-cancer-related pain with inadequate pain relief were treated with oral controlled-release oxycodone for 3-4 weeks. Only a few participating physicians were pain specialists. A total of 356 patients suffering from pain of the musculoskeletal system and receiving oxycodone therapy were monitored for 6 months. Exclusion from the studies was due mainly to inadequate analgesia, side effects, and noncompliance. The efficacy of oxycodone was rated to be better than moderate by most of the patients, quality of life parameters increased significantly, and patient satisfaction was high. The treatment with oral controlled-release oxycodone was a safe and effective option even when used by nonspecialized physicians.

Administration, Oral↗

[Efficacy of opioid analgesia at the superior cervical ganglion in neuropathic head and facial pain].

The efficacy of ganglionic local opioid analgesia (GLOA) at the superior cervical ganglion (SCG) was retrospectively investigated in 74 consecutive patients with neuropathic pain in the head and face region. It was possible to retrospectively analyze the short-term and medium-term treatment results in 64 of 74 patients. The long-term effect was subsequently determined using a standardized questionnaire. The short-term analgesic effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p < 0.001). Within a span of 20 min the mean pain intensity decreased from 65 to 28 on a visual analogue scale. A clinically relevant pain reduction (> or = 30%) was observed in 73% of the patients. The proportion of responders (pain reduction > or = 50%) was 59% after the first blockade. Patients with zoster or trigeminal neuralgia experienced greater pain relief than patients with atypical facial pain or longer lasting postzoster neuralgia. During the course of the blockade series with an average duration of 33 days, a significant medium-term pain reduction of 30% was noted. In the first 3 treatment days, the level of continuous pain declined from 6.3 to 4.3 on a numerical rating scale. Short-term responders reported a better medium-term pain reduction than nonresponders. After 3 years (range: 5 months to 6 years), 21% of 52 patients remained free of pain. The other patients reported often only minimal residual pain or a decrease of pain severity and duration. According to these results, GLOA at the SCG can represent a suitable and simple treatment option for neuropathic facial pain.

Adult↗

[Central pain processing in chronic low back pain. Evidence for reduced pain inhibition].

INTRODUCTION: A study of patients with low back pain (LBP) had revealed altered central pain processing. At an equal pain level LBP patients had considerably more neuronal activation in the somatosensory cortices than controls. In a new analysis of this dataset, we further investigated the differences in central pain processing between LBP patients and controls, looking for possible pathogenic mechanisms. METHODS: Central pain processing was studied by functional magnetic resonance imaging (fMRI), using equally painful pressure stimuli in a block paradigm. In this study, we reanalyzed the fMRI data to statistically compare pain-elicited neuronal activation of both groups. RESULTS: Equally painful pressure stimulation resulted in a significantly lower increase of regional cerebral blood flow (rCBF) in the periaqueductal gray (PAG) of the LBP patients. The analysis further revealed a significantly higher increase of rCBF in LBP than in HC in the primary and secondary somatosensory cortex and the lateral orbitofrontal cortex (LOFK), elicited by these same stimuli. CONCLUSIONS: These findings support a dysfunction of the inhibitory systems controlled by the PAG as a possible pathogenic mechanism in chronic low back pain.

Adult↗

Economic evaluation of Durogesic in moderate to severe, nonmalignant, chronic pain in Germany.

We carried out a cost-effectiveness evaluation of transdermal fentanyl compared to three other widely used opioids: transdermal buprenorphine, sustained-release morphine, and controlled-release oxycodone from a third-party-payers perspective. A decision analytic model with data from a structured database search and from panel data and assumptions was used to derive both cost and utility results. Probabilistic sensitivity analysis was performed to ensure the findings. Transdermal fentanyl patients gain more quality adjusted life-days or quality-adjusted life-years per euro. The incremental cost per quality-adjusted life-year is 1,625.65 euro for transdermal fentanyl compared to sustained-release morphine and 1,003.03 euro compared to CO, and it is cost-saving compared to transdermal buprenorphine (-203.38 euro per patient). Transdermal fentanyl is thus cost-effective compared to both sustained-release morphine and CO and dominant compared to transdermal buprenorphine in the treatment of adults with nonmalignant moderate to severe chronic pain.

Administration, Cutaneous↗

Assessing cognition and psychomotor function under long-term treatment with controlled release oxycodone in non-cancer pain patients.

BACKGROUND: The therapeutic use of opioids can be associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but no data exist about the effect of long-term treatment with controlled release oxycodone (CRO) on driving ability. METHODS: Thirty patients suffering from chronic non-cancer pain who had been treated with stable doses of CRO where included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery that was developed to assess the driving ability of traffic delinquents in Germany was employed. Attention reaction, visual orientation, motor coordination and vigilance were evaluated. The data from a total of 11 parameters were assessed and for each test a relevant score was defined. As the primary endpoint the sum score of the three relevant scores was determined. A weaker statistical means to assess the patients' performance is to compare the test results with an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German legislation. RESULTS: Significant non-inferiority could not be demonstrated for the primary endpoint. However, driving ability as defined as a result above the 16th percentile did not differ significantly between the patients receiving CRO and the age-independent control group. CONCLUSION: The use of CRO does not prohibit driving, but individual assessment is necessary.

Adult↗

Intravenous versus subcutaneous morphine titration in patients with persisting exacerbation of cancer pain.

BACKGROUND: Patients with cancer pain with initially adequate analgesia under oral sustained-release opioid medication may suffer from persisting pain exacerbations. Sometimes even fast help is needed and then optimally performed by intravenous application (IVA) of immediate-release (IR) opioids. This IVA, however, may only be performed by physicians in Germany. OBJECTIVE: We wanted to find out if subcutaneous application of IR-opioids might be an adequate alternative to IVA in persisting pain exacerbations of patients with cancer pain because this could be performed by the nursing staff in Germany as well. DESIGN: An open randomized controlled trial was used to compare intravenous versus subcutaneous morphine titration in persisting pain exacerbations in patients with cancer pain. SETTING/SUBJECTS: Thirty-nine patients with cancer (21 intravenously, 18 subcutaneously) of the pain management department of the university hospital of Cologne, Germany were included into the study. MEASUREMENTS: Calculated from preexisting analgesic medication boli of morphine were given every 5 minutes (intravenously) or 30 minutes (subcutaneously) up to adequate analgesia or intolerable side effects. Pain intensity, nausea, sedation, and some vital parameters were documented before the start, after each application and at the end of titration. RESULTS: Thirty-five patients were pretreated with oral opioids, 4 patients with nonopioid analgesics. Six patients stopped titration because of intolerable side effects (sedation, vomiting). Thirty patients (77%) reported at least sufficient pain reduction, 3 patients were free of pain (intravenously). Mean pain intensity decreased on a visual analogue scale (VAS, 0-100) from 83 to 32 (intravenously) and from 68 to 42 (subcutaneously). Morphine doses ranged from 4 mg to 32 mg (intravenously; mean, 18.5 +/- 9.2 mg) and from 10 mg to 200 mg (subcutaneously mean, 57.9 +/- 59.6 mg). Mean time up to adequate analgesia was 53 (intravenously) 77 min (subcutaneously), respectively. There was no change in vital parameters but an increase of sedation in both groups. The adaptation of the continuous analgesic medication resulted in a stable and lasting pain relief after 4 days in both groups. CONCLUSIONS: Intravenous and subcutaneous-morphine titration are adequate to antagonize persisting pain exacerbations in cancer pain patients quickly and to adapt the continuous opioid analgesic medication.

Adult↗

Pain treatment: a historical overview.

Pain is a common experience of mankind. Pain theories and the management of pain have been modified throughout the history of mankind. This article gives a brief review on pain, pain believes and pain management from early magico-demonic and magico-religious ideas and procedures to more empiric-scientific models; from ancient times and primitive cultures to the 20th century. Due to new anatomical, physiological and biochemical insights, modern pain theories developed in the 19th and 20th century. Modern analgesics were synthesized and new invasive procedures were approved having a major impact on pain management strategies. However, older traditional beliefs and attitudes have not been replaced completely and have survived to some degree in modern patients.

Analgesics↗

[Application of guidelines for the treatment of headache and cancer pain by private practitioners].

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.

Adult↗

[Postoperative pain therapy with hydromorphone and metamizole. A prospective randomized study in intravenous patient-controlled analgesia (PCA)].

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.

Adolescent↗

[Cancer pain management in Germany - results and analysis of a questionnaire].

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.

Aged↗

[Development and state of the in-patient palliative care institutions 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.

Cross-Cultural Comparison↗

[Tetrahydrocannabinol for treatment of chronic pain].

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.

Adult↗

Slow-release tramadol for treatment of chronic malignant pain--an open multicenter trial.

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.

Adult↗

Failure of autologous fresh frozen plasma to reduce blood loss and transfusion requirements in coronary artery bypass surgery.

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.

Aged↗

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↗