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686 BUTRANS (BUPRENORPHINE) TRANSDERMAL PATCHES IMPROVE QUALITY OF LIFE IN PATIENTS WITH OSTEOARTHRITIS (OA)
Topic D: TREATMENT APPROACHES (MEDICAL/INTERVENTIONAL) 684 USE OF TRANSMUCOSAL FENTANYL CITRATE IN SEDO-ANALGESIA IN PATIENTS WHO HAVE BEEN EXPOSED TO DIAGNOSTIC AND THERAPEUTIC UROLOGIC PROCEEDINGS M.R. Lopez ° , R. Albores, M.D. Gonzalez, L. Martin, L. Garcia. Anesthesiologist of Monforte De Lemos County Hospital. Monforte De Lemos (Lugo), Spain Background and Aims: OTFC is a formulation for fentanyl no-invasive administration. We have evaluated its effectiveness and security as an analgesic sedative in urologic ambulatory proceedings in 125 AS A I-IV patients, who were going to undergo painful urologic proceedings, without analgesia nor sedation, due to bad-tolerance. Methods: Doses of 200 mg in diagnostic proceedings and doses of 200– 400 mg, in therapeutic proceedings with OTFC, according to bodyweight (5 mg/kg are recommended), ASA and age (>65 years/200 mg). The OTFC was administered 15 minutes before. Inclusion Criteria: fasting patients accompanied by someone else, banned to drive in 6 hours. Exclusion Criteria: known opiate allergy, imbalances in any disease. Aspects considered: sedation and analgesia levels. Side effects incidence. Results: Level of sedation was satisfactory in all patients, 20 minutes after the administration. Level of satisfaction: quite good (65%), good (15%); two cases presenting nausea and vomits were the only non-desired effects. Conclusions: It was shown that OTFC has a rapid effect. Its presentation made it easy to use by ambulatory patients. Somnolence and hypoxemia can appear. Monitored breath is recommended. We can conclude that administration of Actiq 200–400 mg is a good option for sedo-analgesia in urologic proceedings. It is well tolerated by patients and the level of security is quite large.
685 USEFULNESS OF THE STEP II OF THE WHO ANALGESIC LADDER IN THE TREATMENT OF NON-MALIGNANT CHRONIC PAIN: A MULTICENTRE PILOT-STUDY J.M. L´opez-Mill´an1 ° , J.M. Gonz´alez-Valencia1 , M.A. Merino2 . 1 Department of Anesthesiology and Pain Clinic, Virgen Macarena Universitary Hospital, Seville, 2 Pain Clinic, Virgen del Rocio, Universitary Hospital, Seville, Spain Introduction: The usefulness of the WHO analgesic ladder in the treatment of non-malignant chronic pain is invaluable. However severe pain and rapidly increasing pain constitute a challenge and require aggressive management. Objective: To asses the possibility to set aside the step II of the WHO using the new formulation of a strong opioid as Fentanyl TTS, in this particular setting. Method: Multicentre, prospective, randomized, parallel study. We selected 50 patients with established inclusion and exclusion criteria receiving treatment with NSAIDs to initiate treatment either Fentanyl TTS or Tramadol controlled-release during a titration periodof 2 weeks. When they had reached stable doses they entered a stabilization period of 4 weeks. We recorded intensity of pain using a VAS, satisfaction of the patient (PTSS), sleep (MOS), quality of life (SF-12), health status (EQ-5D) and side effects. Results: During the titration period, the group starting with Fentanyl TTS experienced similar pain relieve than the other starting with oral Tramadol controlled-release, but with less side effects. During the stabilization period, the group with Fentanyl TTS had better pain relieve, better tolerability, higher level of satisfaction and also less side effects. Conclusion: Fentanyl TTS gives the patient the opportunity to titrate a strong opioide from the beginning associated to non-steroidal antiinflammatory drugs and make doses suitable to their pain intensity. Fentanyl TTS gives the clinic the opportunity to set aside the step II f the WHO analgesic ladder in the treatment of non-malignant chronic pain of moderate to severe intensity.
S179 686 BUTRANS (BUPRENORPHINE) TRANSDERMAL PATCHES IMPROVE QUALITY OF LIFE IN PATIENTS WITH OSTEOARTHRITIS (OA) C. McDonald ° , M. Wilson, J. Todd. Napp Pharmaceuticals Limited, Cambridge, Cambridgeshire, UK Background and Aims: This randomised, double-blind, parallel group study compared the efficacy and tolerability of BuTrans transdermal patches (BTP) with sublingual buprenorphine (SLB) in patients with moderate to severe pain caused by hip and/or knee OA. Methods: At entry, patients were randomised to treatment with BTP or SLB. Patients were titrated to pain control for up to 21 days (BTP doses: 5 mg/h to 20 mg/h; SLB doses: 200 mg to 400 mg 8-hourly). Patients who achieved pain control entered a 28-day assessment period. Quality of life was assessed using: sleep questionnaire; Brief Pain Inventory (BPI); Western Ontario and McMaster Universities (WOMAC) OA index. Results: Sleep improved, with patients in both groups showing decreases in the number of nights woken and number of times woken/night. At baseline, nine patients (18%) in the BTP group and 11 (22%) in the SLB group rated their quality of sleep as good or very good. At completion, this had increased to 37 (73%) and 32 (63%), respectively. There were decreases in the scores for all elements of the BPI in both groups, showing an improvement in pain intensity and interference with activities. There were decreases in all elements of the WOMAC OA index. The mean (SD) overall scores at baseline were 54.9 (12.8) for BTP and 53.2 (12.5) for SLB. At completion, these had decreased to 37.4 (16.2) and 37.6 (19.3), respectively. Conclusion: BTP and SLB give comparable improvements in quality of life for patients with moderate to severe OA pain.
687 EFFECTS OF CHRONIC NON-MALIGNANT PAIN AND A SHORT-ACTING OPIOID ON PERFORMANCE IN A DRIVING SIMULATOR H.K. Nilsen1,2 ° , N.I. Landrø1,3 , G.D. Jenssen4 , O. Dale1 , P.C. Borchgrevink1 . 1 Norwegian University of Science and Technology, ˚ Trondheim, St. Olav University Hospital, Trondheim, 2 Alesund Hospital, 3 Dept. of Psychology, University of Oslo, 4 SINTEF, Trondheim, ˚ Alesund, Norway Background and Aims: Little is known about the effects of the shortacting, oral opioid codeine on driving performance in chronic nonmalignant pain patients. Also, chronic pain in it self reduce cognitive functions and might infuence driving. In this controlled study the performance of non-malignant pain patients on long-term use of codeine (CPC) in a videobased driving simulator was compared with chronic non-malignant pain patients not on opioids or other psychoactive medications (CP), and with healthy controls (HC). Methods: Twenty subjects were recruited to each group. They were tested in the simulator twice the same day with an interval of 4.5 hours. Results: Sociodemographic factors and driving experience did not differ between the groups. Mean response-times to traffic symbols were significantly slower both in the CPC (1.10 sec.) and CP (1.10 sec.) group compared to HC (0.98 sec). Number of missed responses to traffic signs were comparable in the pain groups (CPC 6.9%; CP 7.2%), and higher than in HC (4.2%). Tracking, indicating more unstable stearing, was significantly higher in the CPC (8.1 pixel) and CP (9.4) group than in HC (7.7). The CPC group (being their own control) showed similar performance at 1 and 5.5 hours after intake of 60 mg codeine. Conclusions: Compared to the healthy controls, both pain groups presented similar and traffic-relevant poorer results in response-time to traffic signs, number of missed reaction to traffic signs and in stearing. Codeine did not influence driving in the simulator indicating that chronic pain has more negative impact on driving performance.
685 USEFULNESS OF THE STEP II OF THE WHO ANALGESIC LADDER IN THE TREATMENT OF NON-MALIGNANT CHRONIC PAIN: A MULTICENTRE PILOT-STUDY J.M. L´opez-Mill´an1 ° , J.M. Gonz´alez-Valencia1 , M.A. Merino2 . 1 Department of Anesthesiology and Pain Clinic, Virgen Macarena Universitary Hospital, Seville, 2 Pain Clinic, Virgen del Rocio, Universitary Hospital, Seville, Spain Introduction: The usefulness of the WHO analgesic ladder in the treatment of non-malignant chronic pain is invaluable. However severe pain and rapidly increasing pain constitute a challenge and require aggressive management. Objective: To asses the possibility to set aside the step II of the WHO using the new formulation of a strong opioid as Fentanyl TTS, in this particular setting. Method: Multicentre, prospective, randomized, parallel study. We selected 50 patients with established inclusion and exclusion criteria receiving treatment with NSAIDs to initiate treatment either Fentanyl TTS or Tramadol controlled-release during a titration periodof 2 weeks. When they had reached stable doses they entered a stabilization period of 4 weeks. We recorded intensity of pain using a VAS, satisfaction of the patient (PTSS), sleep (MOS), quality of life (SF-12), health status (EQ-5D) and side effects. Results: During the titration period, the group starting with Fentanyl TTS experienced similar pain relieve than the other starting with oral Tramadol controlled-release, but with less side effects. During the stabilization period, the group with Fentanyl TTS had better pain relieve, better tolerability, higher level of satisfaction and also less side effects. Conclusion: Fentanyl TTS gives the patient the opportunity to titrate a strong opioide from the beginning associated to non-steroidal antiinflammatory drugs and make doses suitable to their pain intensity. Fentanyl TTS gives the clinic the opportunity to set aside the step II f the WHO analgesic ladder in the treatment of non-malignant chronic pain of moderate to severe intensity.
S179 686 BUTRANS (BUPRENORPHINE) TRANSDERMAL PATCHES IMPROVE QUALITY OF LIFE IN PATIENTS WITH OSTEOARTHRITIS (OA) C. McDonald ° , M. Wilson, J. Todd. Napp Pharmaceuticals Limited, Cambridge, Cambridgeshire, UK Background and Aims: This randomised, double-blind, parallel group study compared the efficacy and tolerability of BuTrans transdermal patches (BTP) with sublingual buprenorphine (SLB) in patients with moderate to severe pain caused by hip and/or knee OA. Methods: At entry, patients were randomised to treatment with BTP or SLB. Patients were titrated to pain control for up to 21 days (BTP doses: 5 mg/h to 20 mg/h; SLB doses: 200 mg to 400 mg 8-hourly). Patients who achieved pain control entered a 28-day assessment period. Quality of life was assessed using: sleep questionnaire; Brief Pain Inventory (BPI); Western Ontario and McMaster Universities (WOMAC) OA index. Results: Sleep improved, with patients in both groups showing decreases in the number of nights woken and number of times woken/night. At baseline, nine patients (18%) in the BTP group and 11 (22%) in the SLB group rated their quality of sleep as good or very good. At completion, this had increased to 37 (73%) and 32 (63%), respectively. There were decreases in the scores for all elements of the BPI in both groups, showing an improvement in pain intensity and interference with activities. There were decreases in all elements of the WOMAC OA index. The mean (SD) overall scores at baseline were 54.9 (12.8) for BTP and 53.2 (12.5) for SLB. At completion, these had decreased to 37.4 (16.2) and 37.6 (19.3), respectively. Conclusion: BTP and SLB give comparable improvements in quality of life for patients with moderate to severe OA pain.
687 EFFECTS OF CHRONIC NON-MALIGNANT PAIN AND A SHORT-ACTING OPIOID ON PERFORMANCE IN A DRIVING SIMULATOR H.K. Nilsen1,2 ° , N.I. Landrø1,3 , G.D. Jenssen4 , O. Dale1 , P.C. Borchgrevink1 . 1 Norwegian University of Science and Technology, ˚ Trondheim, St. Olav University Hospital, Trondheim, 2 Alesund Hospital, 3 Dept. of Psychology, University of Oslo, 4 SINTEF, Trondheim, ˚ Alesund, Norway Background and Aims: Little is known about the effects of the shortacting, oral opioid codeine on driving performance in chronic nonmalignant pain patients. Also, chronic pain in it self reduce cognitive functions and might infuence driving. In this controlled study the performance of non-malignant pain patients on long-term use of codeine (CPC) in a videobased driving simulator was compared with chronic non-malignant pain patients not on opioids or other psychoactive medications (CP), and with healthy controls (HC). Methods: Twenty subjects were recruited to each group. They were tested in the simulator twice the same day with an interval of 4.5 hours. Results: Sociodemographic factors and driving experience did not differ between the groups. Mean response-times to traffic symbols were significantly slower both in the CPC (1.10 sec.) and CP (1.10 sec.) group compared to HC (0.98 sec). Number of missed responses to traffic signs were comparable in the pain groups (CPC 6.9%; CP 7.2%), and higher than in HC (4.2%). Tracking, indicating more unstable stearing, was significantly higher in the CPC (8.1 pixel) and CP (9.4) group than in HC (7.7). The CPC group (being their own control) showed similar performance at 1 and 5.5 hours after intake of 60 mg codeine. Conclusions: Compared to the healthy controls, both pain groups presented similar and traffic-relevant poorer results in response-time to traffic signs, number of missed reaction to traffic signs and in stearing. Codeine did not influence driving in the simulator indicating that chronic pain has more negative impact on driving performance.