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740 EFFICACY OF THE LIDOCAINE PATCH 5% IN DAILY PRACTICE – RESULTS OF A GERMAN NON-INTERNVENTIONAL MULTICENTER STUDY
Poster Sessions / European Journal of Pain 13 (2009) S55–S285
Results: Eighty one patients were included. Mean age was 64 years and 86% were male. There were no differences in baseline characteristics between groups. The percentage of patients with average pain on movement greater or equal to 4 on the NRS at 24, 48, 72 hours and at 4 days were 23.2 vs 29, 21.9 vs 27.4, 16.9 vs 18.3 and 15.2 vs 15.2 for control and intervention group respectively. Conclusion: Use of topical morphine in this setting did not decrease post-operative sternal wound or drain site pain and patients continue to have significant pain after cardiac surgery. 739 TOPICAL VAPOCOOLANT VERSUS PLACEBO FOR VACCINATION IN INFANTS AND YOUNG CHILDREN R. Goldman1,3 *, M. Ipp2 , J. Manley2 , J. Weisbrot2 , A. Taddio2 . 1 Pediatric Research in Emergency Therapeutics (PRETx) Program, The Division of Pediatric Emergency Medicine, Department of Pediatrics, Child & Family Research Institute (CFRI), BC Children’s Hospital, Vancouver, Canada; 2 The Hospital for Sick Children, University of Toronto, Toronto, Canada; 3 University of British Columbia, Vancouver, Canada Background: Vapocoolants instantly create a cooling effect on the surface by immediate evaporation of the product. Our objective was to determine if a vapocoolant reduces pain compared to placebo in infants and young children undergoing routine immunization. Study Design: Prospective, randomized, double blind, placebo controlled trial in a Pediatric community clinic. Of 66 families approached, 2 declined participation and 1 was excluded as he did not undergo vaccination. Thirty one (49%) were recruited to the vapocoolant group and 32 to the control group. Either vapocoolant or a placebo were administered to the area of immunization using a cotton ball. Children were videotaped and their films were scored by a blinded observer. The primary outcome measures were the Modified Behavioural Pain Scale (MBPS) and Faces Pain ScaleRevised (FPS-R). We also measured parental perception of the treatment. Results: The median difference MBPS score (injection–baseline) did not differ between groups (p = 0.66). There was also no significant difference in the observer FPS-R scores or in parental assessments of the benefits of the study intervention between the two groups. The interobserver intraclass correlation on 39 children’s videotapes was 0.93 (p < 0.001). Conclusion: Vapocoolant did not reduce pain during immunization in infants and young children when applied using a cotton ball. We suggest that future studies will further assess vapocoolants in the young age group in order to determine if direct application using a spray is beneficial to reduce pain from immunization. The Division of Pediatric Emergency Medicine, Department of Pediatrics, The Hospital for Sick Children received an unrestricted educational grant from Gebauer Company, manufacturer of the product studied. 740 EFFICACY OF THE LIDOCAINE PATCH 5% IN DAILY PRACTICE – RESULTS OF A GERMAN NON-INTERNVENTIONAL MULTICENTER STUDY M.A. Ueberall1 *, G. Mueller-Schwefe2 . 1 IFNAP – Institute for Neurosciences, Algesiology and Pediatrics, Nuernberg, Germany; 2 Interdsiciplinary Center for Pain Therapy and Palliative Care, Goeppingen, Germany Background, Aims and Methods: The safety, tolerability and efficacy of the lidocaine patch 5%, a targeted peripheral analgesic with an approved indication for the treatment of postherpetic neuralgia (PHN), has been well established in clinical studies. However, daily practice data suggest a far broader range of indications as well as the need for a significantly longer treatment period than those evaluated so far. For that reason, we evaluated patient-reported outcome data obtained during a non-interventional multicenter study on the efficacy the lidocaine patch.
S213
Results: Until April 2009, 451 treatment cycles were available for analysis (51.3% female, age: 64.5±14.1 yrs.), covering a broad spectrum of indications beside PHN (37%) such as other neuropathies (19.5%), back pain (31.3%), arthrosis (7.5%), and others (4.7%). Mean pain intensity (PI; NRS-11) dropped from 6.9±1.5 at baseline to 1.9±0.4 after 12 weeks. Highest relative PI changes from day to day were observed within the first treatment week, however, improvement continued until week 12. A 50% PI reduction was achieved after 3 weeks and the tailored treatment target was reached after week 4. Over the whole observation period a significant improvement in depression, anxiety, quality-of-life and pain-related restrictions in daily life activities were observed, with maximum treatment responses within the first 4 weeks. Conclusion: Lidcoaine patch 5% is a highly efficacious topical alternative for the treatment of chronic neuropathic pain. Strongest pain relief as well as associated improvements in pain-related restrictions were observed within the first 4 treatment weeks, however, additional beneficial effects could be observed until week 12.
Poster Session 3: Treatment approaches (invasive) and ethics 741 ADDICTED PHYSICIANS – A FATAL TABOO C. Maier *. BG Universit¨ atsklinik Bergmannsheil Ruhr Universit¨ at, Bochum, Germany It is a known fact that physicians – anaesthetists in particular – are in a high risk of addiction diseases. US data show an increase in incidents of addiction, e.g. in the consumption of propofol [1]. In preparation for a systematic German survey in February 2009 participants of two different conferences were interviewed in order to get a first impression of the problem’s dimension. Methods: Interviewees were asked to anonymously complete a questionnaire asking for cases of addiction in their colleagues (known/experienced or colleagues’ reporting), the type of abused drug, the outcome (death, dismissal, rehabilitation) and the postcode of the colleague’s location. Results: 182 physicians completed the questionnaire. 63 of them (35%) reported they had experienced at least one case of addiction. In total there were 195 cases reported, of whom 65% were anaesthetists, 17% nursing staff, 10% surgeons, 7% internists). The abused drugs were: fentanyl (n = 66; 34%), propofol (n = 23; 12%), piritramid (n = 22; 11%) and ketamine (n = 14; 7%). Surprisingly, the misuse of benzodiazepine/hypnotics was seldom mentioned and only four cases of nitrous oxide/halothane abuse were reported. The interviewees also reported 38 cases of death (mortality rate 19%; propofol abuse 71%) and a large number of unknown outcomes. About 30% of the colleagues concerned could continue working in the hospital. Conclusion: Despite of methodological limitations this pilot study confirmed the existence of addiction among German physicians, especially by taking propofol [2]. Ketamine is also gaining increasing relevance. Especially colleagues working in the area of pain therapy/anaesthesiology are at risk. Supporting factors might be the stressful working conditions or the easy availability of these drugs or both. Reference(s) [1] Ward CF. Anesthesiology 1992; 77: 619ff. [2] Wischmeyer et al. A. Anesth Analg 2007; 105: 1066–71. [3] Nutt D, King LA, Saulsbury W, Blakemore C. Lancet 2007; 24: 369(9566): 1047.
Results: Eighty one patients were included. Mean age was 64 years and 86% were male. There were no differences in baseline characteristics between groups. The percentage of patients with average pain on movement greater or equal to 4 on the NRS at 24, 48, 72 hours and at 4 days were 23.2 vs 29, 21.9 vs 27.4, 16.9 vs 18.3 and 15.2 vs 15.2 for control and intervention group respectively. Conclusion: Use of topical morphine in this setting did not decrease post-operative sternal wound or drain site pain and patients continue to have significant pain after cardiac surgery. 739 TOPICAL VAPOCOOLANT VERSUS PLACEBO FOR VACCINATION IN INFANTS AND YOUNG CHILDREN R. Goldman1,3 *, M. Ipp2 , J. Manley2 , J. Weisbrot2 , A. Taddio2 . 1 Pediatric Research in Emergency Therapeutics (PRETx) Program, The Division of Pediatric Emergency Medicine, Department of Pediatrics, Child & Family Research Institute (CFRI), BC Children’s Hospital, Vancouver, Canada; 2 The Hospital for Sick Children, University of Toronto, Toronto, Canada; 3 University of British Columbia, Vancouver, Canada Background: Vapocoolants instantly create a cooling effect on the surface by immediate evaporation of the product. Our objective was to determine if a vapocoolant reduces pain compared to placebo in infants and young children undergoing routine immunization. Study Design: Prospective, randomized, double blind, placebo controlled trial in a Pediatric community clinic. Of 66 families approached, 2 declined participation and 1 was excluded as he did not undergo vaccination. Thirty one (49%) were recruited to the vapocoolant group and 32 to the control group. Either vapocoolant or a placebo were administered to the area of immunization using a cotton ball. Children were videotaped and their films were scored by a blinded observer. The primary outcome measures were the Modified Behavioural Pain Scale (MBPS) and Faces Pain ScaleRevised (FPS-R). We also measured parental perception of the treatment. Results: The median difference MBPS score (injection–baseline) did not differ between groups (p = 0.66). There was also no significant difference in the observer FPS-R scores or in parental assessments of the benefits of the study intervention between the two groups. The interobserver intraclass correlation on 39 children’s videotapes was 0.93 (p < 0.001). Conclusion: Vapocoolant did not reduce pain during immunization in infants and young children when applied using a cotton ball. We suggest that future studies will further assess vapocoolants in the young age group in order to determine if direct application using a spray is beneficial to reduce pain from immunization. The Division of Pediatric Emergency Medicine, Department of Pediatrics, The Hospital for Sick Children received an unrestricted educational grant from Gebauer Company, manufacturer of the product studied. 740 EFFICACY OF THE LIDOCAINE PATCH 5% IN DAILY PRACTICE – RESULTS OF A GERMAN NON-INTERNVENTIONAL MULTICENTER STUDY M.A. Ueberall1 *, G. Mueller-Schwefe2 . 1 IFNAP – Institute for Neurosciences, Algesiology and Pediatrics, Nuernberg, Germany; 2 Interdsiciplinary Center for Pain Therapy and Palliative Care, Goeppingen, Germany Background, Aims and Methods: The safety, tolerability and efficacy of the lidocaine patch 5%, a targeted peripheral analgesic with an approved indication for the treatment of postherpetic neuralgia (PHN), has been well established in clinical studies. However, daily practice data suggest a far broader range of indications as well as the need for a significantly longer treatment period than those evaluated so far. For that reason, we evaluated patient-reported outcome data obtained during a non-interventional multicenter study on the efficacy the lidocaine patch.
S213
Results: Until April 2009, 451 treatment cycles were available for analysis (51.3% female, age: 64.5±14.1 yrs.), covering a broad spectrum of indications beside PHN (37%) such as other neuropathies (19.5%), back pain (31.3%), arthrosis (7.5%), and others (4.7%). Mean pain intensity (PI; NRS-11) dropped from 6.9±1.5 at baseline to 1.9±0.4 after 12 weeks. Highest relative PI changes from day to day were observed within the first treatment week, however, improvement continued until week 12. A 50% PI reduction was achieved after 3 weeks and the tailored treatment target was reached after week 4. Over the whole observation period a significant improvement in depression, anxiety, quality-of-life and pain-related restrictions in daily life activities were observed, with maximum treatment responses within the first 4 weeks. Conclusion: Lidcoaine patch 5% is a highly efficacious topical alternative for the treatment of chronic neuropathic pain. Strongest pain relief as well as associated improvements in pain-related restrictions were observed within the first 4 treatment weeks, however, additional beneficial effects could be observed until week 12.
Poster Session 3: Treatment approaches (invasive) and ethics 741 ADDICTED PHYSICIANS – A FATAL TABOO C. Maier *. BG Universit¨ atsklinik Bergmannsheil Ruhr Universit¨ at, Bochum, Germany It is a known fact that physicians – anaesthetists in particular – are in a high risk of addiction diseases. US data show an increase in incidents of addiction, e.g. in the consumption of propofol [1]. In preparation for a systematic German survey in February 2009 participants of two different conferences were interviewed in order to get a first impression of the problem’s dimension. Methods: Interviewees were asked to anonymously complete a questionnaire asking for cases of addiction in their colleagues (known/experienced or colleagues’ reporting), the type of abused drug, the outcome (death, dismissal, rehabilitation) and the postcode of the colleague’s location. Results: 182 physicians completed the questionnaire. 63 of them (35%) reported they had experienced at least one case of addiction. In total there were 195 cases reported, of whom 65% were anaesthetists, 17% nursing staff, 10% surgeons, 7% internists). The abused drugs were: fentanyl (n = 66; 34%), propofol (n = 23; 12%), piritramid (n = 22; 11%) and ketamine (n = 14; 7%). Surprisingly, the misuse of benzodiazepine/hypnotics was seldom mentioned and only four cases of nitrous oxide/halothane abuse were reported. The interviewees also reported 38 cases of death (mortality rate 19%; propofol abuse 71%) and a large number of unknown outcomes. About 30% of the colleagues concerned could continue working in the hospital. Conclusion: Despite of methodological limitations this pilot study confirmed the existence of addiction among German physicians, especially by taking propofol [2]. Ketamine is also gaining increasing relevance. Especially colleagues working in the area of pain therapy/anaesthesiology are at risk. Supporting factors might be the stressful working conditions or the easy availability of these drugs or both. Reference(s) [1] Ward CF. Anesthesiology 1992; 77: 619ff. [2] Wischmeyer et al. A. Anesth Analg 2007; 105: 1066–71. [3] Nutt D, King LA, Saulsbury W, Blakemore C. Lancet 2007; 24: 369(9566): 1047.