Abstract In four prospective clinical trials, 114 parturients used intravenous patient-controlled remifentanil analgesia during the 1st stage of labour. The median effective dose per bolus was ascertained to be 0.4 μg/kg and the pain scores were reduced with this by a median of 2 on a numerical scale (0–10). Compared with nitrous oxide, 15 parturients included in a cross-over study reported a larger reduction in pain scores during remifentanil analgesia (1.5 vs. 0.5, p =  0.001) and better pain relief scores (2.5 vs. 0.5 on a ranked five point scale 0–4, p  <  0.001). In a parallel study including 45 parturients, epidural analgesia (EDA, 20 ml bupivacaine 0.625 mg/ml and fentanyl 2 μg/ml) was associated with lower pain scores (5.2 vs. 7.3 with remifentanil, p =  0.004) but variables related to satisfaction with analgesia (pain relief score, proportion of mothers with desire to continue with the given medication and termination of the study due to inadequate pain relief) were similar. A comparison of two methods for timing the remifentanil bolus during the uterine contraction cycle suggested that delaying the bolus does not improve analgesia. A period effect was noted in the cross-over trial with higher pain scores and increased drug consumption during the second study period suggesting acute hyperalgesia. Side effects of remifentanil analgesia included respiratory depression warranting oxygen supplementation in 33% of parturients. Sedation was experienced by the parturients using remifentanil and this was scored as stronger than sedation during nitrous oxide and EDA. The number of parturients with nausea did not increase during remifentanil analgesia. Other maternal side effects included dizziness, a difficulty in visual focusing and itching. Foetal heart rate tracing abnormalities were noted. The incidence of abnormal tracings and decreased UapH were not different, however, from that observed during nitrous oxide or EDA. Apgar scores at 1 and 5 minute indicated no neonatal depression.

Abstract Excessive pain after surgery causes many kinds of endocrine, metabolic and inflammatory responses, which may increase postoperative morbidity and mortality - especially among elderly patients. This study evaluated the effect of peripheral and central pain relief techniques after joint surgery. Intravenously administered doses of 100 mg, 200 mg and 300 mg of ketoprofen decreased the requirement for opioid (fentanyl) in a dose-dependent manner by 38%, 45% and 53%, respectively, compared with a placebo, without any noticeable ceiling-effect, when administered after hip and knee arthroplasty. Patients receiving a 300 mg dose of ketoprofen had significantly lower postoperative pain scores than those receiving a placebo. There were no significant differences in incidences of nausea and vomiting, or in the amount of bleeding between the ketoprofen and placebo groups. Intravenous doses of 200 mg of ketoprofen, 150 mg of diclofenac, and 120 mg of ketorolac produced similar postoperative pain scores and requirement for opioid (fentanyl) with no intergroup differences in the incidence of nausea and vomiting and in the amount of bleeding, when administered after hip arthroplasty. The addition of ropivacaine, 1 mg·ml-1, did not decrease the requirement for epidural fentanyl administered via a patient-controlled analgesia device for postoperative pain relief after hip arthroplasty. Both drug infusions provided effective pain relief. The most common adverse effect was pruritus, which occurred in a similar number of patients in both groups. An interscalene brachial plexus block with ropivacaine decreased the dose of PCA-delivered oxycodone by 78% after arthroscopic shoulder surgery while subacromial bursa blockade with ropivacaine decreased it by only 11 % compared to a placebo during the 20 hour study period. Postoperative pain scores were significantly lowest with a interscalene brachial plexus block.

Master of Science / Department of Computing and Information Sciences / John Hatcliff / Medical devices are safety-critical systems whose failure may put human life in danger. They are becoming more advanced and thus more complex. This leads to bigger and more complicated code-bases that are hard to maintain and verify. Model-driven development provides high-level and abstract description of the system in the form of models that omit details, which are not relevant during the design phase. This allows for certain types of verification and hazard analysis to be performed on the models. These models can then be translated into code. However, errors that do not exist in the models may be introduced during the implementation phase. Automated translation from verified models to code may prevent to some extent. This thesis proposes approach for model-driven development and verification of medical devices. Models are created in AADL (Architecture Analysis & Design Language), a language for software and hardware architecture modeling. AADL models are translated to SPARK Ada, contract-based programming language, which is suitable for software verification. Generated code base is further extended by developers to implement internals of specific devices. Created programs can be verified using SPARK tools. A PCA (Patient Controlled Analgesia) pump medical device is used to illustrate the primary artifacts and process steps. The foundation for this work is "Integrated Clinical Environment Patient-Controlled Analgesia Infusion Pump System Requirements" document and AADL Models created by Brian Larson. In addition to proposed model-driven development approach, a PCA pump prototype was created using the BeagleBoard-xM device as a platform. Some components of PCA pump prototype were verified by SPARK tools and Bakar Kiasan.

Os miomas uterinos são os tumores benignos mais comuns do trato genital feminino, sendo que nas mulheres portadoras, 30% são sintomáticos e exigem alguma forma de tratamento. No presente estudo, foram tratadas 35 pacientes sintomáticas com diagnóstico clínico e ultra-sonográfico de mioma uterino, por meio da embolização dos miomas com partículas de polivinil-álcool associadas à obstrução das artérias uterinas com micromolas fibradas. A avaliação clínica e ecográfica foram inicialmente feitas e o acompanhamento realizado após um, três, seis e doze meses do procedimento. O sucesso técnico foi de 94,3%. O volume uterino médio era de 404,53 cm3 antes do tratamento endovascular percutâneo e o sintoma mais freqüente, em 82,9%, a menorragia. A redução média dos volumes uterinos foi de 21,4%, 39,7%, 53,8% e 59,8% respectivamente em um, três, seis e 12 meses (p < 0,01). Houve, também, a redução do volume do nódulo miomatoso dominante em 5%, 18,5%, 26,8% e 32,9% em um, três, seis e 12 meses, respectivamente (p < 0,01). A melhora e o controle da menorragia foram obtidos em 100% das pacientes tratadas. Houve necessidade de histerectomia em uma paciente por insucesso no controle da dor após seis meses do procedimento. A embolização dos miomas uterinos com partículas de polivinil-álcool associada à oclusão endovascular das artérias uterinas com micromolas fibradas é uma alternativa de tratamento minimamente invasivo para as pacientes sintomáticas portadoras de miomas uterinos que proporciona controle e melhora dos sintomas e redução do tamanho dos miomas e do volume uterino. / Uterine fibroids are the most frequent benign tumors of the female genital tract. The tumors are symptomatic in about 30% of the cases, requiring medical treatment. In the present study, a total of 35 clinically symptomatic patients with ultrasonographic diagnosis of fibroids underwent endovascular treatment, which consisted of embolization of the uterine arteries with 355-500 micras PVA particles associated to metallic coils. Clinical and ultrasonographic evaluations were performed at baseline, 1, 3, 6 and 12 months post-intervention. Technical success was obtained in 94.3% of the cases. Mean uterine volume before the procedure was 404.53 cm³ and menorrhagia was the most frequent symptom (82.9%). Mean reduction of the uterine volumes was 21.4%, 39.7%, 53.8% and 59.8% respectively at 1, 3, 6 and 12 months post-intervention. Dominant fibroid size was also significantly reduced after the procedure (5%, 18.5%, 26.8% and 32.9% reductions at 1, 3, 6 and 12 months, respectively; p < 0.01). Vaginal bleeding was abolished in all cases after the 12-month follow up. One patient needed to undergo hysterectomy 6 months after the procedure due to uncontrolled pain. Our results demonstrate uterine arteries embolization is minimally invasive and provides clinical control of the fibroids associated to significant reduction of the uterine volume. Moreover, the technique preserves the uterus and should be considered a therapeutic alternative to standard surgical treatment.

Os miomas uterinos são os tumores benignos mais comuns do trato genital feminino, sendo que nas mulheres portadoras, 30% são sintomáticos e exigem alguma forma de tratamento. No presente estudo, foram tratadas 35 pacientes sintomáticas com diagnóstico clínico e ultra-sonográfico de mioma uterino, por meio da embolização dos miomas com partículas de polivinil-álcool associadas à obstrução das artérias uterinas com micromolas fibradas. A avaliação clínica e ecográfica foram inicialmente feitas e o acompanhamento realizado após um, três, seis e doze meses do procedimento. O sucesso técnico foi de 94,3%. O volume uterino médio era de 404,53 cm3 antes do tratamento endovascular percutâneo e o sintoma mais freqüente, em 82,9%, a menorragia. A redução média dos volumes uterinos foi de 21,4%, 39,7%, 53,8% e 59,8% respectivamente em um, três, seis e 12 meses (p < 0,01). Houve, também, a redução do volume do nódulo miomatoso dominante em 5%, 18,5%, 26,8% e 32,9% em um, três, seis e 12 meses, respectivamente (p < 0,01). A melhora e o controle da menorragia foram obtidos em 100% das pacientes tratadas. Houve necessidade de histerectomia em uma paciente por insucesso no controle da dor após seis meses do procedimento. A embolização dos miomas uterinos com partículas de polivinil-álcool associada à oclusão endovascular das artérias uterinas com micromolas fibradas é uma alternativa de tratamento minimamente invasivo para as pacientes sintomáticas portadoras de miomas uterinos que proporciona controle e melhora dos sintomas e redução do tamanho dos miomas e do volume uterino. / Uterine fibroids are the most frequent benign tumors of the female genital tract. The tumors are symptomatic in about 30% of the cases, requiring medical treatment. In the present study, a total of 35 clinically symptomatic patients with ultrasonographic diagnosis of fibroids underwent endovascular treatment, which consisted of embolization of the uterine arteries with 355-500 micras PVA particles associated to metallic coils. Clinical and ultrasonographic evaluations were performed at baseline, 1, 3, 6 and 12 months post-intervention. Technical success was obtained in 94.3% of the cases. Mean uterine volume before the procedure was 404.53 cm³ and menorrhagia was the most frequent symptom (82.9%). Mean reduction of the uterine volumes was 21.4%, 39.7%, 53.8% and 59.8% respectively at 1, 3, 6 and 12 months post-intervention. Dominant fibroid size was also significantly reduced after the procedure (5%, 18.5%, 26.8% and 32.9% reductions at 1, 3, 6 and 12 months, respectively; p < 0.01). Vaginal bleeding was abolished in all cases after the 12-month follow up. One patient needed to undergo hysterectomy 6 months after the procedure due to uncontrolled pain. Our results demonstrate uterine arteries embolization is minimally invasive and provides clinical control of the fibroids associated to significant reduction of the uterine volume. Moreover, the technique preserves the uterus and should be considered a therapeutic alternative to standard surgical treatment.

Introdução: a analgesia multimodal é amplamente usada para o controle da dor perioperatória em um esforço para reduzir o uso de opioides. A duloxetina é um inibidor seletivo da recaptação da serotonina e noradrenalina com eficácia para estados de dor crônica. O objetivo principal deste estudo foi avaliar a eficácia de duas doses orais de 60 mg de duloxetina em termos de consumo de fentanil durante o período pós-operatório em pacientes submetidos à cirurgia eletiva de artrodese de coluna lombar. Método: este estudo foi um ensaio clínico prospectivo, duplo encoberto, aleatório e controlado com placebo. Os pacientes receberam 60 mg de duloxetina ou placebo idêntico uma hora antes da cirurgia e 24 horas depois. Os sujeitos do estudo foram divididos em dois grupos: grupo C (controle) de indivíduos que receberam o placebo; e grupo D (duloxetina) de indivíduos que receberam 60 mg de duloxetina. O consumo total de fentanil administrado pelo próprio paciente em 24 e 48 horas após a cirurgia foi mensurado. Os desfechos secundários foram os escores de dor e a presença ou ausência de efeitos adversos, tais como cefaleia, náuseas, vômitos, prurido, tonturas e sonolência. Resultados: as características demográficas não diferiram entre os grupos. Houve uma diferença significativa no consumo de fentanil nas primeiras 24 horas entre os grupos C e D (diferença média, 223,11 ± 39,32 ?g; p < 0,001). O consumo de fentanil também diferiu entre os grupos C e D após 48 horas (diferença média, 179,35 ± 32,55 ug; p < 0,00). Os escores de dor em mais de 48 horas não diferiram significativamente entre os grupos. A incidência de efeitos colaterais foi semelhante nos dois grupos. Conclusão: a duloxetina foi associada à redução do consumo de fentanil no pós-operatório de cirurgias sobre a coluna lombar, portanto, sendo eficaz como adjuvante para a analgesia pós-operatória e redução do consumo de opioides / Background: Multimodal analgesia is widely advocated for the control of perioperative pain in an effort to reduce the use of opioids. Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor with efficacy for chronic pain states. The main objective of this study was to evaluate the efficacy of two oral doses of 60 mg duloxetine in terms of fentanyl submitted to elective lumbar spine arthrodesis surgery. Method: This study was prospective, double blind, randomized, and placebo controlled clinical trial. Patients received duloxetine 60 mg or identical placebo one hour before surgery and 24 hours later. The study subjects were divided into two groups: group C (control) of subjects who received placebo; and group D (duloxetine) from subjects received 60 mg. The total fentanyl consumption by the patient himself at 24 and 48 hours after surgery was measured. Secondary outcomes were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, pruritus, dizziness and drowsiness. Results: Demographic characteristics did not differ between groups. There was a significant difference in fentanyl consumption in the first 24 hours between groups C and D (mean difference, 223.11 ± 39.32 ?g; p < 0.001). Fentanyl consumption also differed between groups C and D after 48 hours (mean difference, 179.35 ± 32.55 ?g; p < 0.00). Pain scores in more than 48 hours did not differ significantly between groups. The incidence of side effects was similar in both groups. Conclusion: Duloxetine was associated with reduction of fentanyl consumption in the postoperative period of surgeries on the lumbar spine, therefore, it was effective as adjuvant for postoperative analgesia and reduction of opioid consumption

No description available.

Diss. (sammanfattning) Stockholm : Karolinska institutet, 2006. / Härtill 4 uppsatser.

Introdução: a analgesia multimodal é amplamente usada para o controle da dor perioperatória em um esforço para reduzir o uso de opioides. A duloxetina é um inibidor seletivo da recaptação da serotonina e noradrenalina com eficácia para estados de dor crônica. O objetivo principal deste estudo foi avaliar a eficácia de duas doses orais de 60 mg de duloxetina em termos de consumo de fentanil durante o período pós-operatório em pacientes submetidos à cirurgia eletiva de artrodese de coluna lombar. Método: este estudo foi um ensaio clínico prospectivo, duplo encoberto, aleatório e controlado com placebo. Os pacientes receberam 60 mg de duloxetina ou placebo idêntico uma hora antes da cirurgia e 24 horas depois. Os sujeitos do estudo foram divididos em dois grupos: grupo C (controle) de indivíduos que receberam o placebo; e grupo D (duloxetina) de indivíduos que receberam 60 mg de duloxetina. O consumo total de fentanil administrado pelo próprio paciente em 24 e 48 horas após a cirurgia foi mensurado. Os desfechos secundários foram os escores de dor e a presença ou ausência de efeitos adversos, tais como cefaleia, náuseas, vômitos, prurido, tonturas e sonolência. Resultados: as características demográficas não diferiram entre os grupos. Houve uma diferença significativa no consumo de fentanil nas primeiras 24 horas entre os grupos C e D (diferença média, 223,11 ± 39,32 ?g; p < 0,001). O consumo de fentanil também diferiu entre os grupos C e D após 48 horas (diferença média, 179,35 ± 32,55 ug; p < 0,00). Os escores de dor em mais de 48 horas não diferiram significativamente entre os grupos. A incidência de efeitos colaterais foi semelhante nos dois grupos. Conclusão: a duloxetina foi associada à redução do consumo de fentanil no pós-operatório de cirurgias sobre a coluna lombar, portanto, sendo eficaz como adjuvante para a analgesia pós-operatória e redução do consumo de opioides / Background: Multimodal analgesia is widely advocated for the control of perioperative pain in an effort to reduce the use of opioids. Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor with efficacy for chronic pain states. The main objective of this study was to evaluate the efficacy of two oral doses of 60 mg duloxetine in terms of fentanyl submitted to elective lumbar spine arthrodesis surgery. Method: This study was prospective, double blind, randomized, and placebo controlled clinical trial. Patients received duloxetine 60 mg or identical placebo one hour before surgery and 24 hours later. The study subjects were divided into two groups: group C (control) of subjects who received placebo; and group D (duloxetine) from subjects received 60 mg. The total fentanyl consumption by the patient himself at 24 and 48 hours after surgery was measured. Secondary outcomes were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, pruritus, dizziness and drowsiness. Results: Demographic characteristics did not differ between groups. There was a significant difference in fentanyl consumption in the first 24 hours between groups C and D (mean difference, 223.11 ± 39.32 ?g; p < 0.001). Fentanyl consumption also differed between groups C and D after 48 hours (mean difference, 179.35 ± 32.55 ?g; p < 0.00). Pain scores in more than 48 hours did not differ significantly between groups. The incidence of side effects was similar in both groups. Conclusion: Duloxetine was associated with reduction of fentanyl consumption in the postoperative period of surgeries on the lumbar spine, therefore, it was effective as adjuvant for postoperative analgesia and reduction of opioid consumption

Bakgrund: Sedering används ofta som komplement till regional och lokal anestesi. Sedering kan ges av anestesipersonal (ACS) eller genom patientkontrollerad sedering (PCS). Denna litteraturöversikt syftar till att jämföra dessa metoder. Syfte: Att jämföra patientkontrollerad sedering med sedering given av anestesipersonal avseende skillnad i maximalt sederingsdjup, total läkemedelsdos och tid till utskrivning. Metod: Systematisk litteraturöversikt med narrativ syntes. Litteratursökning i databaserna Pubmed, CINAHL, Scopus och Embase. Det primära utfallet var maximalt sederingsdjup. Sekundära utfall var total läkemedelsdos, samt tid till utskrivning från uppvakningsavdelning. Resultat: 10 studier inkluderades i resultatet (totalt 717 patienter). Studierna hanterar olika ingrepp såsom koloskopier, bronkoskopier och ledplastik. Majoriteten av studierna visade signifikanta skillnader till PCS-gruppernas fördel, med ett ytligare sederingsdjup, en lägre total läkemedelsdos och en kortare tid till utskrivning från uppvakningsavdelning. Stor spridning sågs inom alla grupper gällande total läkemedelsdos. Diskussion/ slutsatser: Resultatet stöds av liknande studier. Ett ytligare sederingsdjup leder till mindre risk för biverkningar för patienten. Eftersom PCS återger ett visst självbestämmande till patienten, ger denne möjlighet att själv välja sederingsdjup i stunden, samt att patienten ges beslutet att tacka ja eller nej till PCS gör att denna sederingsmetod blir ett sätt att arbeta personcentrerat. Vidare forskning krävs, exempelvis större RCT och studier angående patienters upplevelser av PCS. Nyckelord: Patientkontrollerad sedering, sederingsdjup, läkemedelsdos, utskrivningstid, personcentrerad vård / Background: Sedation is often used as a supplement to regional and local anesthesia. Sedation can be given as anesthesia personnel-controlled sedation (ACS) or as patient-controlled sedation (PCS). This systematic review aims to compare these methods. Aim: To compare patient-controlled sedation with anesthesia personnel-controlled sedation regarding maximum depth of sedation, total drug dose and time to discharge. Methods: Systematic review with narrative synthesis. The research material was collected from Pubmed, CINAHL, Scopus and Embase. Primary outcome was maximum depth of sedation. Secondary outcomes were total drug dose and time to discharge from PACU (post anesthesia care unit). Result: 10 trials were included in the result (a total of 717 patients). The trials handle various procedures such as colonoscopies, bronchoscopies and arthroplasty. The majority of the trials showed significant differences in favour of PCS, with a lighter depth of sedation, a lower total drug dose and a shorter time to discharge from PACU. Regarding total drug dose, a large fluctuation was seen in all groups. Discussion/ conclusion: The result is supported by similar trials. A lighter depth of sedation reduces the risk of side effects for the patient. PCS is a way to practice person-centered care, when power is given back to the patient to freely choose the depth of sedation. The patient is also given the decision to say yes or no to PCS. Further research is required, for example larger RCT:s and studies regarding patients experiences of PCS. Keywords: Patient-controlled sedation, depth of sedation, drug dose, time to discharge, person-centered care