Summary
Background
Fibromyalgia is a heterogeneous condition that appears to be associated with physiological and biochemical disturbances of pain modulation, and that consequently affects numerous other facets of life. Tramadol is currently being explored as an option to manage fibromyalgia pain and other symptoms because of its inhibitory activity of reuptake of neurotransmitters, but its safety and efficacy have not yet been established in these patients.
Objective
To evaluate the effectiveness and safety of tramadol on the management of symptoms of the syndrome.
Methods
We searched CENTRAL, MEDLINE, EMBASE, LILACS, Opengrey, ClinicalTrials.gov and WHO‐ICTRP for randomised controlled trials analysing the association between tramadol used for fibromyalgia either single‐agent or in combination with other drugs. Two reviewers independently extracted data and assessed risk of bias using the Cochrane risk‐of‐bias tool for all included studies. Quality of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Results
Four RCTs comprising 459 patients were included. Tramadol—either as a single‐agent or in combination with an antidepressant or analgesic—had a positive effect on pain. Tramadol combined with analgesic showed improved quality of life over placebo as measured by the Fibromyalgia Impact Questionnaire at 91 days. However, this difference did not hold for tramadol as a single agent against placebo. The evidence in these articles was rated “low” using the GRADE approach. No serious adverse events were reported. No improvement in depression and quality of sleep were observed.
Conclusions
This systematic review found a dearth of clinical trials on tramadol in patients with fibromyalgia. Although the combination of monoamine and opioid mechanism of tramadol has shown positive effects for fibromyalgia, the available evidence is not sufficient to support or refute the use of tramadol in clinical practice for pain or symptom management.
Protocol registration number in the PROSPERO database: CRD42017062139.
Introdução: Crianças prematuras tendem a apresentar atrasos no desenvolvimento neuropsicomotor devido à imaturidade e à propensão de lesões no sistema nervoso central. Objetivo: Descrever o perfil epidemiológico e motor de crianças atendidas no follow-up da Maternidade Balbina Mestrinho (MBM) em Manaus/AM, verificando a associação entre diferentes fatores socioambientais e clínicos com o desenvolvimento motor (DM). Métodos: Foram avaliadas 25 crianças acompanhadas no follow-up da MBM, por meio da Escala Motora Infantil de Alberta e aplicação de questionário estruturado contendo dados clínicos e epidemiológicos. Resultados: Foi detectado que todas as crianças eram prematuras e 44% apresentaram atipicidade no DM, relacionada principalmente a idade corrigida (p=0,015) e ao grau de escolaridade materna (p=0,019). Conclusão: O elevado índice de atipicidade no DM pode estar associado ao perfil amostral, cuja prematuridade infere em fragilidade de seus sistemas. Assim, sugere-se que maiores investigações sejam realizadas, a fim de relacionar outros fatores com o DM.
IntroductionCongenital heart disease (CHD) comprises the anatomic malformations that jeopardise the structure and function of the heart. It can be extremely complex and serious, corresponding to 30% of all deaths in the first month of life. The surgical approach for adequate treatment requires postoperative mechanical ventilation. The most critical decision related to the postoperative management of patients submitted to cardiac surgery is the right time for extubation, especially because not only abrupt or inadequate discontinuation of ventilatory support can lead to clinical decline and necessity of reintubation but also extended time of mechanical ventilation, which can lead to complications, such as pneumonia, atelectasis, diaphragm hypertrophy, and increasing morbidity and mortality.Methods and analysisThis systematic review plans to include individual parallel, cross-over and cluster randomised controlled trials regarding any breathing trial test to predict extubation success in children submitted to cardiac surgery due to CHD. Studies with paediatric patients submitted to cardiac surgery for congenital cardiopathy repair, attended at a critical care unit, and under mechanical ventilatory support will be included. The main outcomes analysed will be success of extubation, reduction of pulmonary complications and time reduction of mechanical ventilation.Ethics and disseminationWe will not treat patients directly; therefore, ethics committee approval was not necessary because it is not a primary study. We expect that this study may improve healthcare and medical assistance, helping healthcare professionals with routine daily decisions regarding the correct time for extubation.PROSPERO registration numberCRD42021223999.
IntroductionOxygen is the most common drug used in critical care patients to correct episodes of hypoxaemia. The adoption of new technologies in clinical practice, such as closed-loop systems for an automatic oxygen titration, may improve outcomes and reduce the healthcare professionals’ workload at the bedside; however, certainty of the evidence regarding the safety and benefits still remains low. We aim to evaluate the effectiveness, efficacy and safety of the closed-loop oxygen control for patients with hypoxaemia during the hospitalisation period by conducting a systematic review and meta-analysis.Methods and analysisMEDLINE, CENTRAL, EMBASE, LILACS, CINAHL and LOVE evidence databases will be searched. Randomised controlled trials and cross-over studies investigating the PICO (Population, Intervention, Comparator and Outcome) framework will be included. The primary outcomes will be the time in the peripheral oxygen saturation target. Secondary outcomes will include time for oxygen weaning time; length of stay; costs; adverse events; mortality; healthcare professionals’ workload, and percentage of time with hypoxia and hyperoxia. Two reviewers will independently screen and extract data and perform quality assessment of included studies. The Cochrane risk of bias tool will be used to assess risk of bias. The RevMan V.5.4 software will be used for statistical analysis. Heterogeneity will be analysed using I2statistics. Mean difference or standardised mean difference with 95% CI and p value will be used to calculate treatment effect for outcome variables.Ethics and disseminationEthical approval is not required because this systematic review and meta-analysis is based on previously published data. Final results will be published in peer-reviewed journals and presented at relevant conferences and events.PROSPERO registration numberCRD42022306033.
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