- Email: [email protected]
692 OPIOID TREATMENT FOR BREAKTROUGH PAIN IN PATIENTS WITH CHRONIC NON-CANCER PAIN
S180
European Journal of Pain 2006, Vol 10 (suppl S1)
Abstracts, 5th EFIC Congress, Free Presentations
688 THE EFFECTIVENESS AND TOLERANCE OF OXYCODONE IN OPIOID SWITCHING
690 EXPERIENCE OF TREATMENT OF 10,411 PATIENTS IN RUSSIA
V. Ortiz ° , A. Arroita, M. L´opez, L. Aguilera. Pain Unit, Department of Anaesthesia and Reanimation, Hospital De Basurto, Bilbao, Spain
N.A. Osipova1 ° , V.V. Osipova1 , N.I. Lubitsev1 , M.V. Lukianov2 . 1 Herzen Research Oncology Institute, Moscow, 2 National Research Center of Surgery, Moscow, Russia
Introduction: The opioid switching has been proposed as being effective in the treatment of pain, improving the efficacy of the first opioid or tolerance to adverse effects. Materials and Methods: 50 patients were studied with chronic nononcological pain, receiving opioid treatment with an insufficient analgesic effect (56%), or which was intolerated, and who were subsequently rotated to oxycodone. The analgesic effect was evaluated using EVA and noting the adverse effects (dizziness, drowsiness, nausea, dry mouth and constipation). Results: Pain control (table 1) Table 1 Pain control
Day 15
Day 30
Day 90
Excellent ↓ EVA >70% Good ↓ EVA 50−70% Normal ↓ EVA 30−50% Bad ↓ EVA <30%
16% 50% 24% 10%
20% 46% 24% 10%
18% 54% 18% 10%
Adverse effects: Constipation: 22%; Dizziness: 18%; Drowsiness: 26%; Dry mouth: 12%; Nausea: 6%. In 10% of cases, the treatment was suspended: 6% due to ineffectiveness and 4% due to intolerance. Conclusions: 1. Opioid switching is effective in the treatment of non-oncological pain 2. Oxycodone is effective, safe, and well-tolerated in opioid switching 3. Opioid present inter-individual variations, both in terms of analgesic efficacy and adverse effects.
689 TRANSDERMAL BUPRENORPHINE IN THE TREATMENT OF NEUROPATHIC PAIN A. Orts1 ° , R. Salda˜na1 , A. Hermira2 . 1 Unidad del Dolor, Cl´ınica Universal, Madrid, 2 Anestesia y Reanimaci´on, Hospital Doce De Octubre, Madrid, Spain Background and Aims: Treatment of neuropathic pain with opioid analgesics is controversial. Some studies have indicated that neuropathic is only slightly responsive to opioid analgesics. However, several studies show that adequate analgesia can be obtained, since opioids produce analgesia by affecting different pain pathways. Methods: In the present study we tested effectiveness of buprenorphine in eight neuropathic pain patients of our Chronic Pain Unit, and who received transdermal buprenorphine (Transtec® , Gr¨unenthalTM ). We registered their diagnosis, maintenance doses of buprenorphine, therapeutic effectiveness and adverse effects. Results: Eight neuropathic patients who received transdermal buprenorphine were evaluated. The average age was 60 years-old, and 62.5% of patients were female. Diagnoses were: a) Paresthetic meralgia of the femoral cutaneous nerve (2 cases) b) Diabetic neuropathy (1 case) c) Brachial plexopathy (2 cases) d) Dorsal neuralgia (1 case) e) Posthoracotomy pain (1 case) f) Trigeminal neuralgia (1 case). Average doses of transdermal buprenorphine were 35.9 mcg/h. Maximal doses were 52.5 mcg/h. Pain turned from severe into mild-moderate pain in 50% of the patients. Both cases of brachial plexopathy, and one of two cases of paresthetic meralgia improved. No pain relief was observed in patients with trigeminal neuralgia. Posthoracotomy pain was adequately reduced by buprenorphine. In dorsal neuralgia and diabetic neuropathy patients, buprenorphine patch had to be removed due to side effects (local reactions in the first case, and nausea-vomiting in the second). Conclusions: Transdermal buprenorphine is a well tolerated and safe drug, that can be considered an effective therapy for patients with neuropathic pain.
Background and Aims: The stable combination of tramadol 37.5 mg/ paracetamol 325 mg (Zaldiar – Z) possesses three mechanisms of action. Russian Program GARANT focused on pharmaco-epidemiology of various types of acute and chronic pain (AP, CP). Methods: Open multicentral non-interventional observations conducted with 10,411 patients (age 48.1±1.5, F – 54.8%, M – 45.2%) with AP and CP. Clinical diagnoses, concomitant diseases, pain relief (VRC 0−4), BP and HR, doses of Z, adverse events (AE), withdrawal ratio were registered. Results: The list of 65 pain diagnoses summarized in vertebrogenic pain (34.9%), posttraumatic (24%), pain in joints (15.4%), out-patients post-op pain relief (11.8%), etc. The baseline pain: moderate – 31.8%, severe – 68.2%. Dose of Z was 2.7 + 1.5 tabs in the first day of therapy. Pain significantly decreased or stopped in 88% of patients with moderate and in 80.1% with severe baseline pain in 6 hours. Pain significantly decreased or stopped in 97% – moderate and 99% – severe at the 7th day of therapy (Z 1.7 + 1.4 tabs). AE were seen in 6.6% of patients: dizziness 1.5%, somnolence 0.7%, nausea 1.9%, vomiting 0.1%, skin reactions 0.2%, etc. Nausea and vomiting were the reasons for withdrawal in 0.25% of patients. Conclusion: In this study Z was effective, had favorable safety profile in AP and CP with moderate to severe degree.
691 TRAMADOL/PARACETAMOL (ZALDIAR): EXPERIENCE OF TREATMENT OF 10,411 PATIENTS IN RUSSIA N.A. Osipova ° , V.V. Osipova, N.I. Lubitsev, M.V. Lukianov. Moscow P.A. Herzen Research Oncology Institute, Moscow, Russia Background and Objectives: The stable combination of tramadol 37.5 mg/paracetamol 325 mg (Zaldiar – Z) possesses three mechanism of action. Russian Program GARANT focused on pharmacoepidemiology of various types of acute and chronic pain (AP, CP). Methods: Open non-interventional observations conducted with 10,411 patients (age 48.1+1.5, F – 54.8%, M – 45.2%) with AP and CP. Clinical diagnoses, concomitant diseases, pain relief (VRC 0−4), BP and HR, doses of Z, adverse events (AE), withdrawal ratio were registered. Results: The list of 65 pain diagnoses summarized in vertebrogenic pain (34.9%), posttraumatic (24%), pain in joints (15.4%), out-patients post-op pain relief (11.8%), etc. The baseline pain: moderate – 31.8%, severe – 68.2%. Dose of Z was 2.7+1.5 tabs. in the first day of therapy. Pain significantly decreased or stopped in 88% of patients with moderate and in 80.1% with severe baseline pain in 6 hours. Pain was absent in 83% of patients with moderate and 67% with severe baseline pain at the 7th day of therapy (Z 1.7+1.4 tabs). AE were seen in 6.6% of patients: dizziness 1.5%, somnolence 0.7%, nausea 1.9%, vomiting 0.1%, skin reactions 0.2%, etc. Nausea and vomiting were the reasons for withdrawal in 0.25% of patients. Conclusion: In this study Z was effective, had favorable safety profile in AP and CP with moderate to severe degree.
692 OPIOID TREATMENT FOR BREAKTROUGH PAIN IN PATIENTS WITH CHRONIC NON-CANCER PAIN E. Ozyuvaci ° , F. Kutlu. Department of Anesthesiology and Reanimation, S.B. Istanbul Educational and Research Hospital, Istanbul, Turkiye Background and Aims: The aim of the study the current pharmacologic management of breakthrough pain in chronic pain in non-cancer patients. Methods: This is a 5 months (January–May 2006) prospective study has initiated in our pain clinic. We followed up 40 non-cancer patients. Response to treatment was evaluated by a visual analogue scale of pain
Topic D: TREATMENT APPROACHES (MEDICAL/INTERVENTIONAL) (0 = no pain, 10 = worst pain) and recorded before and every 14 days after the beginning of the treatment. The rate of side effects was also recorded. Results: 40 patients (age 61+4.5), 28 female and 12 male. Diagnosed with low back pain (12: 30%), neck pain pain (6: 15%), fibromyalgia (14: 35%), neuropathies (8: 20%). 16 patients received tramadol retard tablet, 14 patients received transdermal fentanyl 25−50 mg/h, 10 patients received kodein 400 mg/daily. Opioids were combined acetaminophen or a non-steroidal anti-inflammatory agent. Other analgesics and co-analgesics included antidepressants and anticonvulsants. Three medicine groups VAS were decreased at the end of the opioid therapy. Tramadol group: baseline VAS: 9.1 + 0.2, last VAS. 4.2 + 1.2, Transdermal group: baseline VAS: 9.1 + 0.4, last VAS: 3.6 + 1.0, Kodein group:baseline VAS: 8.7 + 1.5, last VAS: 3.9 + 0.6. There were not different the between in all groups. We have not observe serious side effects. Conclusions: Breakthrough pain was common in this group of patients with a different of chronic, non-cancer pain syndromes. The data suggested that all groups are effected for non-cancer breakthrough pain. We have no different between in all groups.
693 OXYCODONE CONTROLLED-RELEASE IN NEUROPATHIC PAIN CONTROL M.C. Pace ° , M.B. Passavanti, P. Sansone, M. Maisto, E. Di Costanzo, C. Fittipaldi, C. Aurilio. Department of Anaesthetics, Surgical and Emergency Science, Second University of Naples, Naples, Italy Background and Aims: Opioids are rarely used in neuropathic pain treatment because of their low analgesic efficacy and side effects. Aim of this study was to evaluate the analgesic efficacy and incidence of side effects of Oxycodone controlled release vs Morphine controlled release in patients suffering from neuropathic pain. Methods: After written informed consent we recruited 30 patients with neuropathic pain from different causes and they were randomized in two groups: group O (oxycodone-CR 10 mg/12h) group M (morphine-CR 20 mg/12h). All patients filled a form where they recorded: VAS (1st day after 1−6 hs), daily sleep diary and daily activity, SF-36 and administration of immediate-release morphine as rescue dose and side effects for 8 weeks. Results: After the 1st hour of administration VAS score was significantly lower in Group O (1±0.26 h) compared with group M (4±1.24 h) (p < 0.05); the following weekly sessions evidenced a reduction of 20 mm VAS score and sleep quality in both groups. Rescue doses were administrated by 33% of patients in group O compared with 60% in group M (p < 0.05). Vomiting and itching were more frequent in group M rather than group O (p < 0.05); no significant differences for nausea and constipation were observed. Conclusion: Oxycodone-CR shows a better efficacy rather than MorphineCR in neuropathic pain control because of its biphasic absorption pattern with lower side effects and a better quality of life.
694 QUALITY-OF-LIFE ASSESSMENT OF ONCE-DAILY OROS® HYDROMORPHONE VERSUS PLACEBO IN PATIENTS WITH MODERATE TO SEVERE CHRONIC OSTEOARTHRITIS PAIN U. Richarz1 ° , R.R. Eckardt2 , S. Khanna3 , J. Thipphawong3 , R. Skowronski3 , J.C. Tudor3 . 1 Medical Affairs, Janssen Cilag Europe, Baar, Switzerland, 2 Private Practice: Richard R. Eckardt, MD, 3 ALZA Corporation, Mountain View, CA, USA Background and Aims: Osteoarthritis (OA) is a common condition affecting the knee and hip joints, resulting in chronic pain, functional limitations that restrict lifestyle, and reduced quality of life. Once-daily OROS® hydromorphone has demonstrated analgesic effects comparable to twice-daily oxycodone in patients with chronic OA pain. This presentation describes the health-related quality-of-life (HrQOL) effects of OROS® hydromorphone in patients with moderate-to-severe OA pain not consistently controlled by other medications.
S181 Methods: This was a 14-week, double-blind, placebo-controlled study. Patients received once-daily OROS® hydromorphone (8 or 16 mg [8 mg for first 2 weeks]) or placebo. The primary efficacy measure was the Office Visit Pain Intensity Rating. HrQOL assessments included the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and the Medical Outcomes Survey (MOS) Sleep Assessment questionnaire. Results: 990 patients were randomized, 981 received treatment, and 472 completed the 14-week trial. 509 (51.9%) patients withdrew prematurely, (primary reasons, lack of efficacy [placebo] and adverse events [OROS® hydromorphone]). Results on the primary endpoint are reported elsewhere. After 14 weeks in the trial, OROS® hydromorphone [8 mg/day and/or 16 mg/day] was associated with reduced pain, stiffness, and difficulty performing daily activities (mean WOMAC overall AUC ratio: P < 0.05 vs placebo [LOCF]). At study endpoint, OROS hydromorphone 8 mg/day and 16 mg/day were associated with improved sleep (mean MOS sleep disturbance, somnolence, and sleep quantity subscale AUC ratios: P 0.05 vs placebo. Conclusions: Once-daily OROS® hydromorphone reduces the impact of chronic pain on daily life, when compared to placebo, in patients with moderate-to-severe chronic OA pain. 695 POSTOPERATIVE ANALGESIA WITH SUSTAINED RELEASE OXYCODONE COMPARED TO INTRAVENOUSLY GIVEN PIRITRAMIDE “ON DEMAND” FOLLOWING TOTAL ENDOPROTHESIS. A PILOT STUDY P. Rohr ° . Klinikum Saarbr¨ucken, Saarbr¨ucken, Germany Background and Aims: This study was designed to compare sustained release (SR) oxycodone to the therapeutic use of piritramide and its effectiveness, practicability, patients’ satisfaction and adverse effects. Method: In this open label, controlled pilot study 30 patients (ASA I-III) with total endoprothesis of the hip were included. Postoperatively oral oxycodone (n = 15) or intravenously piritramide (N = 15) were administered. Analgesic effectiveness (NRS) was evaluated for rest pain, movement pain, feasibility of painful procedures (mobilisation, physiotherapy), adverse events, patients’ satisfaction and appraisal of doctors and nurses regarding effectiveness/tolerability. Results: The preoperative average pain was comparable (6.0±2.4 vs. 6.5±1.8). Oxycodone was more effective in relief of rest pain on the first and second postoperative day (3.1±2.7 vs. 4.7±2.6; 1.4±2.2 vs. 2.2±2.5), and for movement pain on the first postoperative day (5.3±3.0 vs. 6.1±2.2). Painful procedures were more likely to be performed with oxycodone (30 vs. 18). Patients’ satisfaction showed no difference, the therapeutic impact for both groups was regarded as good. Conclusions: Postoperative analgesia with SR oxycodone seems to be comparable to the analgesic effect of intravenously given piritramide, but seems to result in a more favourable relief of pain especially in the first postoperative days. SR oxycodone seems to be an effective, easy to handle and from a clinical point of view feasible concept for the management of postoperative pain. Further studies are needed to support these findings. 696 EFFECT OF ALVIMOPAN ON HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN SUBJECTS WITH OPIOID-INDUCED GASTROINTESTINAL (GI) SIDE EFFECTS: THE PAC-QOL QUESTIONNAIRE R. Sabatowski1 ° , M. Tark2 , L. Frank3 , A. Rentz3 , C. Kleoudis4 , T. Bell4 , A. Pierce4 , J. Snidow4 . 1 Department of Anesthesiology, University of Cologne, Germany, 2 Georgia Medical Research Institute, Marietta, GA, 3 Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, 4 GlaxoSmithKline, Research Triangle Park, NC, USA Background: Opioid therapy is often complicated by GI side effects, which can cause a substantial burden of illness and impair patient HRQOL. Aim: To assess the effects of alvimopan, an investigational peripherally acting mu-opioid receptor (PAM-OR) antagonist, on HRQOL in subjects
European Journal of Pain 2006, Vol 10 (suppl S1)
Abstracts, 5th EFIC Congress, Free Presentations
688 THE EFFECTIVENESS AND TOLERANCE OF OXYCODONE IN OPIOID SWITCHING
690 EXPERIENCE OF TREATMENT OF 10,411 PATIENTS IN RUSSIA
V. Ortiz ° , A. Arroita, M. L´opez, L. Aguilera. Pain Unit, Department of Anaesthesia and Reanimation, Hospital De Basurto, Bilbao, Spain
N.A. Osipova1 ° , V.V. Osipova1 , N.I. Lubitsev1 , M.V. Lukianov2 . 1 Herzen Research Oncology Institute, Moscow, 2 National Research Center of Surgery, Moscow, Russia
Introduction: The opioid switching has been proposed as being effective in the treatment of pain, improving the efficacy of the first opioid or tolerance to adverse effects. Materials and Methods: 50 patients were studied with chronic nononcological pain, receiving opioid treatment with an insufficient analgesic effect (56%), or which was intolerated, and who were subsequently rotated to oxycodone. The analgesic effect was evaluated using EVA and noting the adverse effects (dizziness, drowsiness, nausea, dry mouth and constipation). Results: Pain control (table 1) Table 1 Pain control
Day 15
Day 30
Day 90
Excellent ↓ EVA >70% Good ↓ EVA 50−70% Normal ↓ EVA 30−50% Bad ↓ EVA <30%
16% 50% 24% 10%
20% 46% 24% 10%
18% 54% 18% 10%
Adverse effects: Constipation: 22%; Dizziness: 18%; Drowsiness: 26%; Dry mouth: 12%; Nausea: 6%. In 10% of cases, the treatment was suspended: 6% due to ineffectiveness and 4% due to intolerance. Conclusions: 1. Opioid switching is effective in the treatment of non-oncological pain 2. Oxycodone is effective, safe, and well-tolerated in opioid switching 3. Opioid present inter-individual variations, both in terms of analgesic efficacy and adverse effects.
689 TRANSDERMAL BUPRENORPHINE IN THE TREATMENT OF NEUROPATHIC PAIN A. Orts1 ° , R. Salda˜na1 , A. Hermira2 . 1 Unidad del Dolor, Cl´ınica Universal, Madrid, 2 Anestesia y Reanimaci´on, Hospital Doce De Octubre, Madrid, Spain Background and Aims: Treatment of neuropathic pain with opioid analgesics is controversial. Some studies have indicated that neuropathic is only slightly responsive to opioid analgesics. However, several studies show that adequate analgesia can be obtained, since opioids produce analgesia by affecting different pain pathways. Methods: In the present study we tested effectiveness of buprenorphine in eight neuropathic pain patients of our Chronic Pain Unit, and who received transdermal buprenorphine (Transtec® , Gr¨unenthalTM ). We registered their diagnosis, maintenance doses of buprenorphine, therapeutic effectiveness and adverse effects. Results: Eight neuropathic patients who received transdermal buprenorphine were evaluated. The average age was 60 years-old, and 62.5% of patients were female. Diagnoses were: a) Paresthetic meralgia of the femoral cutaneous nerve (2 cases) b) Diabetic neuropathy (1 case) c) Brachial plexopathy (2 cases) d) Dorsal neuralgia (1 case) e) Posthoracotomy pain (1 case) f) Trigeminal neuralgia (1 case). Average doses of transdermal buprenorphine were 35.9 mcg/h. Maximal doses were 52.5 mcg/h. Pain turned from severe into mild-moderate pain in 50% of the patients. Both cases of brachial plexopathy, and one of two cases of paresthetic meralgia improved. No pain relief was observed in patients with trigeminal neuralgia. Posthoracotomy pain was adequately reduced by buprenorphine. In dorsal neuralgia and diabetic neuropathy patients, buprenorphine patch had to be removed due to side effects (local reactions in the first case, and nausea-vomiting in the second). Conclusions: Transdermal buprenorphine is a well tolerated and safe drug, that can be considered an effective therapy for patients with neuropathic pain.
Background and Aims: The stable combination of tramadol 37.5 mg/ paracetamol 325 mg (Zaldiar – Z) possesses three mechanisms of action. Russian Program GARANT focused on pharmaco-epidemiology of various types of acute and chronic pain (AP, CP). Methods: Open multicentral non-interventional observations conducted with 10,411 patients (age 48.1±1.5, F – 54.8%, M – 45.2%) with AP and CP. Clinical diagnoses, concomitant diseases, pain relief (VRC 0−4), BP and HR, doses of Z, adverse events (AE), withdrawal ratio were registered. Results: The list of 65 pain diagnoses summarized in vertebrogenic pain (34.9%), posttraumatic (24%), pain in joints (15.4%), out-patients post-op pain relief (11.8%), etc. The baseline pain: moderate – 31.8%, severe – 68.2%. Dose of Z was 2.7 + 1.5 tabs in the first day of therapy. Pain significantly decreased or stopped in 88% of patients with moderate and in 80.1% with severe baseline pain in 6 hours. Pain significantly decreased or stopped in 97% – moderate and 99% – severe at the 7th day of therapy (Z 1.7 + 1.4 tabs). AE were seen in 6.6% of patients: dizziness 1.5%, somnolence 0.7%, nausea 1.9%, vomiting 0.1%, skin reactions 0.2%, etc. Nausea and vomiting were the reasons for withdrawal in 0.25% of patients. Conclusion: In this study Z was effective, had favorable safety profile in AP and CP with moderate to severe degree.
691 TRAMADOL/PARACETAMOL (ZALDIAR): EXPERIENCE OF TREATMENT OF 10,411 PATIENTS IN RUSSIA N.A. Osipova ° , V.V. Osipova, N.I. Lubitsev, M.V. Lukianov. Moscow P.A. Herzen Research Oncology Institute, Moscow, Russia Background and Objectives: The stable combination of tramadol 37.5 mg/paracetamol 325 mg (Zaldiar – Z) possesses three mechanism of action. Russian Program GARANT focused on pharmacoepidemiology of various types of acute and chronic pain (AP, CP). Methods: Open non-interventional observations conducted with 10,411 patients (age 48.1+1.5, F – 54.8%, M – 45.2%) with AP and CP. Clinical diagnoses, concomitant diseases, pain relief (VRC 0−4), BP and HR, doses of Z, adverse events (AE), withdrawal ratio were registered. Results: The list of 65 pain diagnoses summarized in vertebrogenic pain (34.9%), posttraumatic (24%), pain in joints (15.4%), out-patients post-op pain relief (11.8%), etc. The baseline pain: moderate – 31.8%, severe – 68.2%. Dose of Z was 2.7+1.5 tabs. in the first day of therapy. Pain significantly decreased or stopped in 88% of patients with moderate and in 80.1% with severe baseline pain in 6 hours. Pain was absent in 83% of patients with moderate and 67% with severe baseline pain at the 7th day of therapy (Z 1.7+1.4 tabs). AE were seen in 6.6% of patients: dizziness 1.5%, somnolence 0.7%, nausea 1.9%, vomiting 0.1%, skin reactions 0.2%, etc. Nausea and vomiting were the reasons for withdrawal in 0.25% of patients. Conclusion: In this study Z was effective, had favorable safety profile in AP and CP with moderate to severe degree.
692 OPIOID TREATMENT FOR BREAKTROUGH PAIN IN PATIENTS WITH CHRONIC NON-CANCER PAIN E. Ozyuvaci ° , F. Kutlu. Department of Anesthesiology and Reanimation, S.B. Istanbul Educational and Research Hospital, Istanbul, Turkiye Background and Aims: The aim of the study the current pharmacologic management of breakthrough pain in chronic pain in non-cancer patients. Methods: This is a 5 months (January–May 2006) prospective study has initiated in our pain clinic. We followed up 40 non-cancer patients. Response to treatment was evaluated by a visual analogue scale of pain
Topic D: TREATMENT APPROACHES (MEDICAL/INTERVENTIONAL) (0 = no pain, 10 = worst pain) and recorded before and every 14 days after the beginning of the treatment. The rate of side effects was also recorded. Results: 40 patients (age 61+4.5), 28 female and 12 male. Diagnosed with low back pain (12: 30%), neck pain pain (6: 15%), fibromyalgia (14: 35%), neuropathies (8: 20%). 16 patients received tramadol retard tablet, 14 patients received transdermal fentanyl 25−50 mg/h, 10 patients received kodein 400 mg/daily. Opioids were combined acetaminophen or a non-steroidal anti-inflammatory agent. Other analgesics and co-analgesics included antidepressants and anticonvulsants. Three medicine groups VAS were decreased at the end of the opioid therapy. Tramadol group: baseline VAS: 9.1 + 0.2, last VAS. 4.2 + 1.2, Transdermal group: baseline VAS: 9.1 + 0.4, last VAS: 3.6 + 1.0, Kodein group:baseline VAS: 8.7 + 1.5, last VAS: 3.9 + 0.6. There were not different the between in all groups. We have not observe serious side effects. Conclusions: Breakthrough pain was common in this group of patients with a different of chronic, non-cancer pain syndromes. The data suggested that all groups are effected for non-cancer breakthrough pain. We have no different between in all groups.
693 OXYCODONE CONTROLLED-RELEASE IN NEUROPATHIC PAIN CONTROL M.C. Pace ° , M.B. Passavanti, P. Sansone, M. Maisto, E. Di Costanzo, C. Fittipaldi, C. Aurilio. Department of Anaesthetics, Surgical and Emergency Science, Second University of Naples, Naples, Italy Background and Aims: Opioids are rarely used in neuropathic pain treatment because of their low analgesic efficacy and side effects. Aim of this study was to evaluate the analgesic efficacy and incidence of side effects of Oxycodone controlled release vs Morphine controlled release in patients suffering from neuropathic pain. Methods: After written informed consent we recruited 30 patients with neuropathic pain from different causes and they were randomized in two groups: group O (oxycodone-CR 10 mg/12h) group M (morphine-CR 20 mg/12h). All patients filled a form where they recorded: VAS (1st day after 1−6 hs), daily sleep diary and daily activity, SF-36 and administration of immediate-release morphine as rescue dose and side effects for 8 weeks. Results: After the 1st hour of administration VAS score was significantly lower in Group O (1±0.26 h) compared with group M (4±1.24 h) (p < 0.05); the following weekly sessions evidenced a reduction of 20 mm VAS score and sleep quality in both groups. Rescue doses were administrated by 33% of patients in group O compared with 60% in group M (p < 0.05). Vomiting and itching were more frequent in group M rather than group O (p < 0.05); no significant differences for nausea and constipation were observed. Conclusion: Oxycodone-CR shows a better efficacy rather than MorphineCR in neuropathic pain control because of its biphasic absorption pattern with lower side effects and a better quality of life.
694 QUALITY-OF-LIFE ASSESSMENT OF ONCE-DAILY OROS® HYDROMORPHONE VERSUS PLACEBO IN PATIENTS WITH MODERATE TO SEVERE CHRONIC OSTEOARTHRITIS PAIN U. Richarz1 ° , R.R. Eckardt2 , S. Khanna3 , J. Thipphawong3 , R. Skowronski3 , J.C. Tudor3 . 1 Medical Affairs, Janssen Cilag Europe, Baar, Switzerland, 2 Private Practice: Richard R. Eckardt, MD, 3 ALZA Corporation, Mountain View, CA, USA Background and Aims: Osteoarthritis (OA) is a common condition affecting the knee and hip joints, resulting in chronic pain, functional limitations that restrict lifestyle, and reduced quality of life. Once-daily OROS® hydromorphone has demonstrated analgesic effects comparable to twice-daily oxycodone in patients with chronic OA pain. This presentation describes the health-related quality-of-life (HrQOL) effects of OROS® hydromorphone in patients with moderate-to-severe OA pain not consistently controlled by other medications.
S181 Methods: This was a 14-week, double-blind, placebo-controlled study. Patients received once-daily OROS® hydromorphone (8 or 16 mg [8 mg for first 2 weeks]) or placebo. The primary efficacy measure was the Office Visit Pain Intensity Rating. HrQOL assessments included the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and the Medical Outcomes Survey (MOS) Sleep Assessment questionnaire. Results: 990 patients were randomized, 981 received treatment, and 472 completed the 14-week trial. 509 (51.9%) patients withdrew prematurely, (primary reasons, lack of efficacy [placebo] and adverse events [OROS® hydromorphone]). Results on the primary endpoint are reported elsewhere. After 14 weeks in the trial, OROS® hydromorphone [8 mg/day and/or 16 mg/day] was associated with reduced pain, stiffness, and difficulty performing daily activities (mean WOMAC overall AUC ratio: P < 0.05 vs placebo [LOCF]). At study endpoint, OROS hydromorphone 8 mg/day and 16 mg/day were associated with improved sleep (mean MOS sleep disturbance, somnolence, and sleep quantity subscale AUC ratios: P 0.05 vs placebo. Conclusions: Once-daily OROS® hydromorphone reduces the impact of chronic pain on daily life, when compared to placebo, in patients with moderate-to-severe chronic OA pain. 695 POSTOPERATIVE ANALGESIA WITH SUSTAINED RELEASE OXYCODONE COMPARED TO INTRAVENOUSLY GIVEN PIRITRAMIDE “ON DEMAND” FOLLOWING TOTAL ENDOPROTHESIS. A PILOT STUDY P. Rohr ° . Klinikum Saarbr¨ucken, Saarbr¨ucken, Germany Background and Aims: This study was designed to compare sustained release (SR) oxycodone to the therapeutic use of piritramide and its effectiveness, practicability, patients’ satisfaction and adverse effects. Method: In this open label, controlled pilot study 30 patients (ASA I-III) with total endoprothesis of the hip were included. Postoperatively oral oxycodone (n = 15) or intravenously piritramide (N = 15) were administered. Analgesic effectiveness (NRS) was evaluated for rest pain, movement pain, feasibility of painful procedures (mobilisation, physiotherapy), adverse events, patients’ satisfaction and appraisal of doctors and nurses regarding effectiveness/tolerability. Results: The preoperative average pain was comparable (6.0±2.4 vs. 6.5±1.8). Oxycodone was more effective in relief of rest pain on the first and second postoperative day (3.1±2.7 vs. 4.7±2.6; 1.4±2.2 vs. 2.2±2.5), and for movement pain on the first postoperative day (5.3±3.0 vs. 6.1±2.2). Painful procedures were more likely to be performed with oxycodone (30 vs. 18). Patients’ satisfaction showed no difference, the therapeutic impact for both groups was regarded as good. Conclusions: Postoperative analgesia with SR oxycodone seems to be comparable to the analgesic effect of intravenously given piritramide, but seems to result in a more favourable relief of pain especially in the first postoperative days. SR oxycodone seems to be an effective, easy to handle and from a clinical point of view feasible concept for the management of postoperative pain. Further studies are needed to support these findings. 696 EFFECT OF ALVIMOPAN ON HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN SUBJECTS WITH OPIOID-INDUCED GASTROINTESTINAL (GI) SIDE EFFECTS: THE PAC-QOL QUESTIONNAIRE R. Sabatowski1 ° , M. Tark2 , L. Frank3 , A. Rentz3 , C. Kleoudis4 , T. Bell4 , A. Pierce4 , J. Snidow4 . 1 Department of Anesthesiology, University of Cologne, Germany, 2 Georgia Medical Research Institute, Marietta, GA, 3 Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, 4 GlaxoSmithKline, Research Triangle Park, NC, USA Background: Opioid therapy is often complicated by GI side effects, which can cause a substantial burden of illness and impair patient HRQOL. Aim: To assess the effects of alvimopan, an investigational peripherally acting mu-opioid receptor (PAM-OR) antagonist, on HRQOL in subjects