Comparison between 200 mg generic celecoxib hard capsules and Celebra®: bioequivalence study in healthy male and female subjects under fasting conditions after a single dose / Comparação entre celecoxibe genérico de 200 mg em cápsulas duras e Celebra®: estudo de bioequivalência em indivíduos saudáveis do sexo masculino e feminino, em jejum, após uma dose única

ABSTRACT BACKGROUND AND OBJECTIVES: The objective of this study was to assess the bioequivalence between two 200 mg celecoxib hard capsule formulations administered to healthy male and female participants under fasting conditions with the aim of providing an alternative pharmaceutical product to the reference drug, Celebra®. METHODS: A randomized, open label, single dose, 2x2 crossover trial was conducted with 60 adult healthy subjects under fasting conditions comparing single doses of two celecoxib hard capsules formulation. Pharmacokinetic parameters were calculated following the determination of drugs concentrations in human plasma using a validated liquid chromatography with a tandem mass spectrometer detector method (LC-MS/MS). RESULTS: Statistical analysis provided geometric mean of test/reference ratio, confidence intervals, intra-subject variation coefficient and power of the test to the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞. Confidence intervals for the geometric mean (90% CI) of the test/reference drugs for celecoxib were 98.26 to 122.75% for Cmax, 100.27% to 110.78% for AUC0-t, and 96.87% to 110.29% for AUC0-∞. The power of the test found was 95.09% for Cmax, 100.00% for AUC0-t, and 99.99% for AUC0-∞. CONCLUSION: The formulations met the Brazilian standards for interchangeability, as the confidence intervals for Cmax and AUC0-t ratios are within the range of 80% to 125%, thus meeting the requirements of the legislation during market registration. The researched product was approved by the regulatory authorities and became a commercially competitive option to the reference product for the Brazilian population.

RESUMO JUSTIFICATIVA E OBJETIVOS: O objetivo deste estudo foi avaliar a bioequivalência entre duas formulações de cápsulas duras de celecoxibe de 200 mg administradas a participantes saudáveis do sexo masculino e feminino em condições de jejum com o objetivo de fornecer um produto farmacêutico alternativo ao fármaco de referência, Celebra®. MÉTODOS: Estudo randomizado, aberto, de dose única e cruzado 2x2. Foi conduzido com 60 indivíduos adultos saudáveis em condições de jejum, comparando doses únicas de duas formulações de cápsulas duras de celecoxibe. Os parâmetros farmacocinéticos foram calculados após a determinação das concentrações dos fármacos no plasma humano usando uma cromatografia líquida validada com um método detector de espectrômetro de massa em tandem (LC-MS/MS). RESULTADOS: A análise estatística forneceu a média geométrica da razão teste/referência, os intervalos de confiança, o coeficiente de variação intra-sujeito e o poder do teste para os parâmetros farmacocinéticos Cmáx, AUC0-t e AUC0-∞. Os intervalos de confiança para a média geométrica (IC 90%) dos fármacos teste/referência para o celecoxibe foram 98,26 a 122,75% para Cmáx, 100,27% a 110,78% para AUC0-t e 96,87% a 110,29% para AUC0-∞. O poder do teste encontrado foi de 95,09% para Cmáx, 100,00% para AUC0-t e 99,99% para AUC0-∞. CONCLUSÃO: As formulações atenderam aos padrões brasileiros de intercambialidade, pois os intervalos de confiança para as razões Cmáx e AUC0-t estão dentro da faixa de 80% a 125%, atendendo, assim, às exigências da legislação para o registro no mercado. O produto pesquisado foi aprovado pelas autoridades regulatórias e tornou-se uma opção comercialmente competitiva ao produto de referência para a população brasileira.

Brazilian version of the Pasero Opioid-Induced Sedation Scale: cross-cultural adaptation study / Versión brasileña de la escala Pasero Opioid-Induced Sedation Scale: estudio de adaptación transcultural / Versão brasileira da Pasero Opioid-Induced Sedation Scale: estudo de adaptação transcultural

ABSTRACT Objective: Perform a cross-cultural adaptation of the Pasero Opioid-induced Sedation Scale to the Brazilian setting. Method: This is a methodological study using Beaton's framework, which consists in six stages: translation, synthesis of translations, re-translation, expert committee, pre-test, and sending the adapted version of the instrument to the author of the original. The study was carried out from April to December 2021. The research was conducted in a private hospitalin the city of São Paulo, in the adult hospitalization and critical care units. It was approved by the research ethics committee. Results: After translation, translation synthesis and back-translation steps, the version was evaluated by the expert committee, requiring two rounds to obtain acceptable CVI values above 0.80. In the pre-test phase, the scale was well understood, with a CVI of 0.98. Conclusion: The scale was adapted for the Brazilian context; however, further studies will be needed to analyze validity and reliability evidence.

RESUMEN Objetivo: Realizar la adaptación transcultural de la escala de Pasero Opioid-induced Sedation Scale para el contexto brasileño. Método: Estudio metodológico, utilizando el marco de referencia de Beaton, que consta de seis fases: traducción, síntesis de traducciones, traducción inversa, comité de expertos, prueba previa, y envío del instrumento adaptado ala autora del instrumento original. El estudio se realizó de abril a diciembre de 2021, y a la investigación se condujo en un hospital privado, ubicado en la ciudad de São Paulo, en las unidades de hospitalización de adultos y cuidados críticos. Recibió la aprobación del comité de ética. Resultados: Después de las etapas de traducción, síntesis de traducción y traducción inversa, la versión fue evaluada por un comité de expertos, con dos rondas para obtener valores aceptables de índice de validez de contenido superiores a 0,80. En la fase previa a la prueba, la escala mostró una buena comprensión, con una puntuación de 0,98. Conclusión: La escala fue adaptada para el contexto brasileño, sin embargo, serán necesarios más estudios para analizar las evidencias de validez y confiabilidad.

RESUMO Objetivo: Realizar adaptação transcultural da escala Pasero Opioid-Induced Sedation para o cenário brasileiro. Método: Estudo metodológico, utilizado referencial de Beaton, composto por seis fases: tradução, síntese das traduções, retradução, comitê de especialistas, pré-teste e envio dos instrumentos adaptados ao autor do instrumento original. Estudo foi realizado de abril a dezembro de 2021. A pesquisa desenvolveu-se em um hospital privado, localizado no município de São Paulo, nas unidades de internação e críticas adultos. Recebeu aprovação do comitê de ética. Resultados: Após as etapas de tradução, síntese de tradução e retrotradução a versão foi avaliada pelo comitê de especialistas, com duas rodadas para obtenção de valores aceitáveis de índice de validade de conteúdo acima de 0,80. Na fase de pré-teste a escala apresentou boa compreensão com score de 0,98. Conclusão: A escala foi adaptada para o contexto brasileiro, no entanto, novos estudos serão necessários para análises de evidências de validade e confiabilidade.

Mioclonías positivas y negativas en paciente con enfermedad renal crónica / Positive and negative myoclonus in a patient with end stage renal disease

Introducción: Las mioclonías son contracciones musculares paroxísticas de corta duración o pérdida abrupta del tono muscular, denominadas mioclonías positivas y negativas, respectivamente. Se presenta un caso clínico de mioclonías positivas y negativas generalizadas y se pretende describir los múltiples mecanismos fisiopatológicos y etiologías que lo desencadenan. Presentación del caso: Hombre de 35 años, con diabetes mellitus tipo 1 complicada con enfermedad renal diabética en hemodiálisis, desarrolló una bacteriemia asociada a catéter por Staphylococcus aureus y presentó mioclonías positivas y negativas. Se identificaron como posibles desencadenantes la uremia, la infección y los fármacos con potencial promioclónico; el hallazgo incidental de una lesión isquémica en núcleo caudado no explicaba la semiología encontrada en el paciente. Se hizo el control y retiro de todos los factores promioclónicos enunciados, junto a manejo farmacológico con levetiracetam, y con ello se logró el control de los síntomas. Discusión: Los pacientes con enfermedad renal crónica son susceptibles a la acumulación de productos tóxicos de tipo guanidinas, que tienen potencial para producir mioclonías. Además, las infecciones, el uso de fármacos con potencial promioclónico y lesiones estructurales como las isquemias corticales son etiologías que deben considerarse en el diagnóstico diferencial. El mayor impacto en los síntomas se observa con el control del factor desencadenante, y, en caso de persistir, la terapia farmacológica proporciona buenos resultados. Conclusión: Las mioclonías son trastornos del movimiento relativamente comunes en la enfermedad renal crónica. La identificación del desencadenante es crucial para su manejo junto al uso de fármacos con actividad antimioclónica.

Introduction: Myoclonus are paroxysmal muscle contractions of short duration or abrupt loss of muscle tone, called positive and negative myoclonus respectively. A clinical case of generalized positive and negative myoclonus is presented and the aim is to describe the multiple pathophysiological mechanisms and etiologies that trigger it. Case presentation: A 35-year-old man with type 1 diabetes mellitus complicated by diabetic kidney disease on hemodialysis developed catheter-associated bacteremia due to Staphylococcus aureus and presented positive and negative myoclonus. Uremia, infection, and drugs with pro-myoclonic potential were identified as possible triggers; The incidental finding of an ischemic lesion in the caudate nucleus did not explain the semiology found in the patient. The control and removal of all the pro-myoclonic factors mentioned was carried out, along with pharmacological management with levetiracetam, thus achieving control of the symptoms. Discussion: Patients with chronic kidney disease are susceptible to the accumulation of guanidine-type toxic products, which have the potential to produce myoclonus. Furthermore, infections, the use of drugs with pro-myoclonic potential and structural lesions such as cortical ischemia are etiologies that should be considered in the differential diagnosis. The greatest impact on symptoms is observed with the control of the triggering factor and if it persists, pharmacological therapy provides good results. Conclusion: Myoclonus are relatively common movement disorders in chronic kidney disease. Identification of the trigger is crucial for its management along with the use of drugs with anti-myoclonic activity.

Postoperative pain management in the elderly. Literature review

Timely post-operative pain management in elderly patients is critically important. Given their physiological changes and comorbidities, management in this group of patients is different from the rest of the population. Knowledge of potentially inappropriate medications (Beers criteria) is relevant because of the presence of comorbidities in this population. Although acetaminophen continues to be safe, non-steroidal anti-inflammatory agents produce several adverse effects which need to be considered before they are used. On the other hand, opioids continue to be one of the pillars in analgesia, with due consideration of their adverse affects and interactions, and the need for dose adjustments. Adequate postoperative pain management prevents adverse effects and the risk of developing chronic pain.

El manejo oportuno del dolor en la población anciana durante el periodo posoperatorio es de vital importancia. Este grupo de pacientes, dado sus cambios fisiológicos y comorbilidades, requieren un manejo diferente al resto de la población. Es relevante conocer cuáles medicamentos son potencialmente inapropiados para su uso (criterios de Beers) ante las comorbilidades de esta población. Si bien el acetaminofén continúa siendo seguro, los antiinflamatorios no esteroideos causan varios efectos adversos que ameritan consideración antes de su uso; por su parte, los opioides siguen siendo uno de los pilares analgésicos, teniendo en cuenta sus efectos adversos y valorando la necesidad de ajuste de dosis e interacciones. El adecuado manejo del dolor posoperatorio previene desenlaces adversos y el riesgo de cronificación.

Comparative Evaluation of Postoperative Pain Scores and Opioid Consumption in Septorhinoplasty After Administration of Single-Dose Preemptive Paracetamol and Ibuprofen: A Randomized Controlled Trial

Abstract Introduction Septorhinoplasty operates on the nose's bone and cartilage and is ensued by severe postoperative pain. Objective The objective of this study is to evaluate the effects of preoperative administration of intravenous (IV) paracetamol and ibuprofen on postoperative pain scores in patients undergoing septorhinoplasty. Methods A total of 150 patients undergoing septorhinoplasty were randomly assigned into 3 groups with 50 patients in each group. The control group (group A) was administered 100 ml saline solution; the paracetamol group (group B) was administered 1,000 mg of IV paracetamol in 100 ml of saline solution; and the ibuprofen group (group C) was administered 800 mg of IV ibuprofen in 100 ml of saline solution before surgery. Opioid analgesics were employed to achieve postoperative analgesia. Postoperative pain was evaluated using the visual analogue scale (VAS). Postoperative opioid consumption and adverse effects were also recorded for each patient. Results In comparison with group A, the score in the VAS of groups B and C was statistically lower in all the time intervals (p < 0.05). In the 1st and 6th hours postoperatively, group C's score in the VAS in was lower than that of group B (p < 0.05). In the control group, total opioid consumption was highest in all time intervals (p < 0.05). In group C, total opioid consumption was significantly lower than in group B in the 0 to 6 and 6 to 12 hours intervals. (p < 0.05). Conclusion The single-dose preemptive administration of ibuprofen has a more profound postoperative analgesic effect than paracetamol in the first 6 hours after septorhinoplasty. After the first 6 hours postsurgery, there is no difference between ibuprofen and paracetamol in terms of analgesic effect.

Effects of cannabinoids on pain control, quality of life and opioid-sparing in cancer patients: systematic review / Utilização de canabinoides no controle da dor, na qualidade de vida e no efeito poupador de opioides em pacientes com câncer: revisão sistemática

ABSTRACT BACKGROUND AND OBJECTIVES: Cannabinoids, such as delta-9-tetrahydrocannabinol and cannabidiol, have several therapeutic properties that may be useful in medicine. The objective of this study was to analyze the impact of cannabinoid use on pain control, quality of life and opioid-sparing in patients with advanced cancer. CONTENTS: A systematic review of the evidence for the use of cannabinoids in patients with advanced cancer was conducted on 1) Pain control; 2) Quality of life; and 3) Opioid-sparing effect. PubMed, Web of Science and Cochrane databases were searched for articles, written in English, published between January 1, 2011, and December 31, 2022, with the filters "randomized controlled trials" and "clinical trials". Using oral formulations of cannabinoids was accepted as "intervention" and placebo as "control". Risk of bias analysis was performed with Cochrane's RoB 2 and ROBINS-I tools. This review followed the 2020 PRISMA- statement. Ten studies were included, with 1169 participants, most with moderate risk of bias. The studies were from Australia (n=4), Canada (n=1), Israel (n=1), Mexico (n=1), The United Kingdom (n=1); two were multinationals. Eight were randomized, placebo-controlled trials; two were non-randomized studies. The most used formulation was nabiximols oral spray. Cannabinoids provide a clinical improvement in pain control. Evidence of improved quality of life with cannabinoids is inconclusive. Cannabinoids do not affect the daily dose of opioids in refractory cancer pain. Cannabinoid use cannot be said to have an opioid-sparing effect. CONCLUSION: It is necessary to expand research on the prescription of cannabinoids in individuals with cancer and other progressive diseases, with several comorbidities and multiple medications, in different health contexts.

RESUMO JUSTIFICATIVA E OBJETIVOS: Os canabinoides, como o delta-9-tetrahidrocanabinol e o canabidiol, possuem propriedades terapêuticas que podem ser úteis em pacientes oncológicos. O objetivo deste estudo foi avaliar o impacto do uso de canabinoides no controle da dor, na melhoria da qualidade de vida, e no efeito poupador de opioides em pacientes com câncer avançado. CONTEÚDO: Realizou-se uma revisão sistemática sobre a evidência da utilização de canabinoides em pacientes com câncer avançado, relativamente a: 1) Controle da dor; 2) Qualidade de vida; e 3) Efeito poupador de opioides. Foram buscados artigos na Pubmed, Web of Science e Cochrane, em inglês, publicados entre 2011 e 2022, com os filtros "randomized controlled trials" e "clinical trials". Aceitaram-se como "intervenção" qualquer uso de formulações orais de canabinoides e como "controle" o uso de placebo. Fez-se análise de viés com as ferramentas da Cochrane RoB 2 e ROBINS-I. Seguiu-se a Declaração PRISMA 2020. Foram incluídos 10 estudos, com 1169 participantes, a maioria com risco moderado de viés. Os estudos provinham de Austrália (n=4), Canadá (n=1), Israel (n=1), México (n=1), Reino Unido (n=1); dois eram multinacionais. Oito eram ensaios randomizados controlados com placebo; dois eram não randomizados. A formulação mais usada foi spray bucal de nabiximóis. Os canabinoides proporcionam uma melhoria clínica do controle da dor. A evidência da melhoria da qualidade de vida com canabinoides é inconclusiva. Os canabinoides não afetam a dose diária de opioides na dor oncológica refratária. Não se pode afirmar que o uso de canabinoides tem um efeito poupador de opioides. CONCLUSÃO: É necessário incrementar a investigação sobre a prescrição de canabinoides em indivíduos com câncer e outras doenças progressivas, com comorbilidades e polimedicação, em diferentes contextos de saúde.

Urinary retention after lipoabdominoplasty: case report / Retenção urinária após lipoabdominoplastia: relato de caso

Introduction: Postoperative urinary retention may predispose to permanent bladder damage. Risk factors include type of anesthesia, type of surgery, and use of anticholinergics, analgesics, and opioids. Once the lesion is established, complementary urodynamic tests are essential for etiological diagnosis and treatment. The objective of this study is to report a case of a patient with urinary retention in the postoperative period of lipoabdominoplasty. Case Report: 27-year-old female patient, without comorbidities or use of continuous medication. She underwent lipoabdominoplasty and evolved postoperatively with urinary retention and bladder distention, diagnosed as detrusor contractility and sensitivity deficit in the urodynamic study. She was maintained in outpatient follow-up with the surgical team and Urology, with a progressive reduction in urinary catheter use and complete removal in eight months of follow-up. Discussion: The objective of aesthetic plastic surgery is to improve the physical appearance of the body. It is subject to complications like other surgical procedures, and pain seems to be the most frequent. Urinary retention may be secondary to the use of opioids, and its diagnosis in the postoperative period of lipoabdominoplasty still has some obstacles. Plication of the rectus muscle diastasis, liposuction, and the use of a compressive abdominal belt make it difficult to identify a possible bladder distention. An episode of bladder overdistention can result in significant morbidity. Conclusion: The present report demonstrated the good evolution of a patient who developed urinary retention in the postoperative period of lipoabdominoplasty. The main diagnostic hypothesis was that it was secondary to the use of opioids.

Introdução: A retenção urinária pós-operatória pode predispor a danos permanentes à bexiga. Os fatores de risco incluem tipo de anestesia, tipo de cirurgia e uso anticolinérgicos, analgésicos e opioides. Uma vez que a lesão está estabelecida, os exames complementares urodinâmicos são fundamentais para diagnóstico etiológico e tratamento. O objetivo deste trabalho é relatar caso de paciente com quadro de retenção urinária no pós-operatório de lipoabdominoplastia. Relato de Caso: Paciente de 27 anos, sexo feminino, sem comorbidades ou uso de medicamentos contínuos. Foi submetida a lipoabdominoplastia, e evoluiu no pós-operatório com quadro de retenção urinária e bexigoma, diagnosticada como acontratilidade detrusora e déficit de sensibilidade no estudo urodinâmico. Manteve acompanhamento ambulatorial com a equipe cirúrgica e a Urologia, com redução progressiva do uso do cateter vesical e retirada completa em oito meses de seguimento. Discussão: O objetivo da cirurgia plástica estética é melhorar o aspecto físico do corpo. Como os demais procedimentos cirúrgicos, está sujeita a complicações e a dor parece ser a mais frequente. A retenção urinária pode ser secundária ao uso de opioides e seu diagnóstico no pós-operatório da lipoabdominoplastia ainda possui alguns obstáculos. A plicatura da diástase do músculo reto, a lipoaspiração e o uso de cinta abdominal compressiva dificultam a identificação do possível bexigoma. Um episódio de hiperdistensão da bexiga pode resultar em morbidade significativa. Conclusão: O presente relato demonstrou boa evolução de paciente que desenvolveu retenção urinária no pós-operatório de lipoabdominoplastia. A principal hipótese diagnóstica foi de ser secundária ao uso de opioide.

Diagnosis of a Case of Hepatotoxicity Due to Drugs and Herbal Supplements in a Hospital in Pasto, Colombia

The liver is a crucial organ in metabolism, and some substances can induce toxic hepatitis with high morbidity and mortality. Chemical and drug-induced liver disease is a diagnostic and therapeutic challenge since it requires extension studies to rule out other entities. We present the case of a 51-year-old female patient without underlying comorbidities, admitted due to symptoms of two-day evolution consisting of progressive jaundice, diarrheal episodes without acholia, or any other additional manifestation. Her condition was caused by the intake of nimesulide, two tablets a day for two days, for pain secondary to a mandibular cyst diagnosed in previous days. During her admission to the emergency room, the patient described chronic consumption of Herbalife® products daily for four years. She presented with elevated transaminases, prolonged prothrombin time (PT), and direct hyperbilirubinemia. Infectious and immunological diseases were ruled out. We decided to start antibiotic and vitamin K coverage. Finally, and by exclusion, a liver biopsy suggested an inflammatory process compatible with drug-induced hepatitis. The woman evolved favorably when the medication and dietary supplement were discontinued. In conclusion, this case constitutes an initial point in advancing research into hepatotoxicity by shared mechanisms of various substances simultaneously, such as what happened to the patient with the parallel use of Herbalife® and nimesulide.

El hígado es un órgano crucial en el metabolismo y algunas sustancias pueden inducir hepatitis toxica con alta morbimortalidad. La enfermedad hepática inducida por sustancias químicas y medicamentos es un desafío tanto diagnostico como terapéutico, puesto que requiere la realización de estudios de extensión para descartar otras entidades. A continuación se presenta el caso de una paciente femenina de 51 años sin comorbilidades de base, ingresada por clínica de 2 días de evolución consistente en ictericia progresiva, episodios diarreicos sin acolia ni otra manifestación adicional. Aparentemente, su cuadro fue provocado por la administración de nimesulida, 2 tabletas al día por 2 días, contra el dolor secundario a un quiste mandibular diagnosticado en días anteriores. Durante su ingreso a urgencias la paciente describió consumo crónico, a diario desde hace 4 años, de productos de Herbalife®. Cursa con elevación de transaminasas, prolongación del tiempo de protrombina (TP) e hiperbilirrubinemia directa. Se descartan enfermedades infecciosas e inmunológicas. Se decidió iniciar el cubrimiento antibiótico y vitamina K. Finalmente y por exclusión, se realizó una biopsia hepática que sugirió un proceso inflamatorio compatible con hepatitis inducida por fármacos. La mujer evolucionó favorablemente al suspender la medicación y el suplemento dietético referido. En conclusión, el caso expuesto constituye un punto inicial en el avance hacia la investigación en hepatotoxicidad por mecanismos compartidos de diversas sustancias simultáneamente, como lo sucedido a la paciente con el uso paralelo de Herbalife® y de nimesulida.

Analgesic efficacy of Intraoperative lidocaine infusion in patients undergoing thyroidectomy

SUMMARY OBJECTIVE: A significant proportion of patients may experience moderate pain requiring treatment in the postoperative first 24 h following thyroidectomy. The aim of this study was to investigate the evaluation of postoperative patient-reported pain from intraoperative intravenous infusion of lidocaine in patients undergoing thyroidectomy surgery. METHODS: A total of 40 patients with American Society of Anesthesiologists physical status classifications I and II, aged 18-65 years, who were scheduled for elective thyroidectomy with the same indications under general anesthesia at the Ataturk University Medical Faculty's Ear, Nose, and Throat Clinic between November 2019 and February 2020, were divided into two equal groups as randomized and double-blind. Before induction of anesthesia, patients in the lidocaine group were given 1.5 mg/kg lidocaine IV bolus infusion during the operation and until the end of the first postoperative hour, followed by a continuous infusion of 1.5 mg/kg/h. Patients in the control group were given 0.9% isotonic solution according to the same protocol. In the postoperative period, 50 mg of dexketoprofen trometamol was administered and repeated every 12 h. Postoperative pain scores, additional analgesia, and side effects were recorded. RESULTS: Postoperative pain scores were significantly lower in the lidocaine group (n=20) compared to the control group (n=20) at 30 min and 1st, 2nd, 4th, 8th, and 12th h postoperatively (p < 0.05). Additional analgesia requirements were also significantly lower in the lidocaine group than in the control group (p<0.05). CONCLUSION: We recommended the use of intravenous lidocaine infusion intraoperatively in thyroidectomy surgery as it reduces pain scores.

Evaluation of last-year dental students' knowledge of prescription of analgesics and anti-bacterial agents for pregnant and lactating women

Oral health in pregnant and lactating women can affect maternal and child health. Dental treatments in this period should not have adverse effects on maternal and child health. This study was conducted to investigate the last-year dental students' knowledge of the prescription of analgesics and antibiotics for pregnant and lactating mothers in Isfahan city, Iran. Methods: A total of 104 last-year dental students of Khorasgan Islamic Azad University and Isfahan University of Medical Sciences were recruited in this descriptiveanalytical study. They completed a 16-item questionnaire on the prescription of analgesics and antibiotics for pregnant and lactating mothers. Data were analyzed by SPSS (Version 22) statistical software(t-test). Results: The total mean score of students' knowledge was 9.02±1.91. The highest level of knowledge about the safest analgesic (acetaminophen) was reported for the pregnant patients so that 100% of them had correct information in this regard. Further, the lowest level of knowledge was found for the use of dexamethasone during lactation, as only 10.6% of respondents were able to provide a correct response in this regard. Conclusion: The dental students had average knowledge about the prescription of antibiotics and analgesics for pregnant and lactating patients. To prevent the possible risks for these patients, further information should be provided to dental students

Prevalencia de dolor y su abordaje terapéutico en niños pasibles de cuidados paliativos asistidos en un centro de referencia de Uruguay / Prevalence of pain and its therapeutic approach in children eligible for assisted palliative care in a reference hospital center in Uruguay / Prevalência de dor e sua abordagem terapêutica em crianças submetidas a cuidados paliativos atendidas em um centro hospitalar de referência no Uruguai

Introducción: el tratamiento del dolor es un derecho humano y constituye un pilar de los cuidados paliativos (CP). Este síntoma en niños suele ser subestimado e insuficientemente tratado. Objetivo: conocer la prevalencia del dolor y describir el perfil de uso de fármacos analgésicos, coadyuvantes y procedimientos invasivos en niños asistidos en la Unidad de Cuidados Paliativos Pediátricos del Centro Hospitalario Pereira Rossell (UCPP-CHPR) durante el período 2019-2021. Metodología: se realizó un estudio observacional, descriptivo y retrospectivo mediante revisión de historias clínicas. Resultados: se incluyeron 317 niños, 58% de sexo masculino, con una mediana de edad 6,9 años. Eran portadores de enfermedades neurológicas severas no evolutivas 64%, utilizaban prótesis o tecnología médica 51%. Se encontró registro de presencia de dolor en 35%, de tipo crónico 87%, mixto 55% y de fuentes múltiples 54%. Se detectó uso de escala para evaluación del dolor en 61%, la más utilizada fue r-FLACC. En el grupo de niños con dolor se encontró prescripción de analgésicos en 43% (48/111) y de coadyuvantes 87% (97/111), gabapentina en 78. En todos la vía de administración fue la oral/enteral. Se encontró uso off label de fármacos en 79% y polifarmacia en 82%. Se registraron efectos adversos en 10%. Conclusión: un tercio de los niños asistidos por la UCPP-CHPR, presentaba registros de presencia dolor. La mayoría de tipo crónico, mixto y de fuentes múltiples. Se encontró amplio uso de escalas validadas para evaluación del dolor y alta prescripción de coadyuvantes en relación a la de analgésicos.

Introduction: pain treatment is a human right and a pillar of palliative care (PC). This symptom in children is often underestimated and insufficiently treated. Objective: learn about the prevalence of pain and describe the analgesic drugs' usage profile, adjuvants and invasive procedures in children assisted in the Pediatric Palliative Care Unit of the Pereira Rossell Hospital Center (UCPP-CHPR) during the period 2019-2021. Methodology: observational, descriptive and retrospective study based on the review of medical records. Results: 317 children were included, 58% male, with a median age of 6.9 years. 64% were carriers of severe non-progressive neurological diseases, 51% used prosthetics or medical technology. A record of the presence of pain was found in 35%, chronic type 87%, mixed 55% and multiple sources 54%. The use of a pain assessment scale was detected in 61%, the most used was r-FLACC. In the group of children with pain, analgesics were prescribed in 43% (48/111) and adjuvants in 87% (97/111), gabapentin in 78. In all of them, the administration route was oral/enteral. Off-label use of drugs was found in 79% and polypharmacy in 82%. Adverse effects were recorded in 10%. Conclusion: a third of the children assisted by the UCPP-CHPR showed records of pain presence. Most chronic type, mixed and multiple sources. We found a vast use of validated scales for pain assessment and high prescription of adjuvants in relation to analgesics.

Introdução: o tratamento da dor é um direito humano e constitui um pilar dos Cuidados Paliativos (CP). Este sintoma em crianças é geralmente subestimado e insuficientemente tratado. Objetivo: conhecer a prevalência da dor e descrever o perfil do uso de medicamentos analgésicos, adjuvantes e procedimentos invasivos em crianças atendidas na Unidade de Cuidados Paliativos Pediátricos do Centro Hospitalar Pereira Rossell (UCPP-CHPR) durante o período de 2019-2021. Metodologia: foi realizado um estudo observacional, descritivo e retrospectivo por meio de revisão de prontuários. Resultados: foram incluídas 317 crianças, 58% do sexo masculino, com idade mediana de 6,9 anos. 64% eram portadores de doenças neurológicas graves não evolutivas, 51% usavam próteses ou tecnologia médica. Registro da presença de dor foi encontrado em 35%, do tipo crônica 87%, mista 55% e de origem múltipla 54%. A utilização de escala para avaliação da dor foi detectada em 61%, sendo a mais utilizada a r-FLACC. No grupo de crianças com dor, a prescrição de analgésicos foi encontrada em 43% (48/111) e adjuvantes em 87% (97/111), gabapentina em 78. Ao todo, a via de administração foi oral/enteral. Uso off-label de medicamentos foi encontrado em 79% e polifarmácia em 82%. Efeitos adversos foram registrados em 10%. Conclusão: um terço das crianças atendidas pela UCPP-CHPR apresentou registro da presença de dor. A maioria do tipo crônica, mista e de fontes múltiplas. Encontrou-se ampla utilização de escalas validadas para avaliação da dor e elevada prescrição de coadjuvantes em relação aos analgésicos.

Effect of opioid-sparing analgesia on incidence of sepsis in severely burned patients: a retrospective cohort study / 中华麻醉学杂志

Objective:To evaluate the effects of opioid-sparing analgesia on the incidence of sepsis in severely burned patients in the retrospective cohort study.Methods:The clinical data from patients with severe burns admitted to three teaching hospitals in Guangdong from 2011 to 2020 were retrospectively extracted and analyzed. The patients were divided into 2 groups based on the analgesic regimen within 30 days after injury: continuous opioids analgesia group (continuous opioid infusion at a relative constant rate for more than 72 h) and opioid-sparing analgesia group (patient-controlled intravenous analgesia/intermittent administration/opioid-free analgesia). Patient′s age, severity of burn, inhalation injury and basal pain score at rest were matched by the propensity score at a 1∶1 ratio. The primary outcome measure was the occurrence of sepsis within 90 days of admission. Secondary outcome measures included 30-day and 90-day all-cause mortality, clinical diagnosis of multiple organ dysfunction syndrome, and prevalence of burn wound infection. The amount of opioid used was also recorded.Results:A total of 328 severely burned patients were finally enrolled, with 145 patients in continuous opioid analgesia group and 183 patients in opioid-sparing analgesia group, and 110 pairs of patients (220 cases) were finally matched by the propensity score.Compared with continuous opioid analgesia group, the total consumption of opioid, daily consumption per analgesia, and consumption per burn area were significantly decreased, and the incidence of sepsis and wound infection was decreased( P<0.05), and no significant change was found in the incidence of multiple organ dysfunction syndrome, 30-day and 90-day all-cause mortality in opioid-sparing analgesia group( P>0.05). Conclusions:Compared with the continuous opioid analgesia regimen, opioid-sparing analgesia can reduce the risk of sepsis in severely burned patients.

Application of multimodal low opioid combined with saphenous nerve block analgesia in elderly patients undergoing knee arthroplasty / 中华老年医学杂志

Objective:To investigate the clinical application of multimodal low-opioid combined with saphenous nerve block analgesia in elderly patients undergoing knee arthroplasty.Methods:This study is a randomized controlled study.A total of 60 elderly patients who underwent elective knee arthroplasty in the Department of Orthopedics, the First Hospital of Shanxi Medical University from January 2021 to December 2021 were selected and divided into 2 groups by numerical randomization: mode low opioid analgesia regimen group(observation group)and traditional analgesia regimen group(control group), 30 cases in each group.Observation group: (1)Preemptive analgesia: Oral celecoxib 200 mg, qd.from 3 days before surgery, the mini-mental state examination(MMSE)score was used to evaluate the cognitive function; (2)Intraoperative analgesia: After the prosthesis was installed, choose to inject analgesics around the knee joint(ropivacaine 200 mg, morphine 5 mg, epinephrine 0.25 mg, dexamethasone 5 mg/100 ml normal saline, also known as "cocktail" solution); (3)Postoperative analgesia: After the operation, continuous saphenous nerve block(0.2% ropivacaine, 2 ml/h)was performed under ultrasound guidance, and the dose of nerve block was adjusted according to the degree of rehabilitation training.Control group: no special treatment before and during the operation, traditional postoperative patient-controlled intravenous analgesia(PCIA)was used after the operation, the formula WAs as follows: sufentanil(2 μg/kg)+ flurbiprofen axetil(200-300 mg)+ Tropisetron(5-10 mg). The numerical rating scale(NRS)scores were observed and recorded 1 day before surgery, 6, 12, 24, and 48 hours after surgery; the time of the first active straight leg raising after surgery, the time of landing; the range of motion(ROM)of the knee joint 3, 7, and 14 days after surgery; the American Hospital for Special Surgery Knee Score(HSS)at 14 days, 1, 3, and 6 months after surgery; serum substance P(SP)and interleukin-6(IL-6)concentrations 1 day before surgery and 48 hours after surgery, and adverse events were recorded.Results:Compared with the control group, the patients in the observation group had lower NRS scores at 6, 12, 24, and 48 hours after the operation( t=27.705, 27.532, 21.739, 25.780, all P<0.05); the first active straight leg raising time and the time of landing earlier after the operation, and the knee joint at 3, 7, and 14 days after the operation, the range of motion(ROM)was better( t=35.496, 43.716, 3.766, 5.216, 6.009, all P<0.05). And the American hospital for special surgery knee score(HSS)was higher at 14 days, 1 month, and 3 months after surgery( t=19.247, 32.337, 22.651, all P<0.05), but there was no significant difference at 6 months after surgery.Simultaneously, the serum SP and IL-6 concentrations in the observation group 48 h after the operation were (431.0±11.3)ng/L and(11.9±2.7)ng/L, respectively.Compared with the control group(442.5±15.6)ng/L, (14.4±2.9)ng/L( t=5.362, 4.144, both P<0.05). Compared with the control group, which were lower than those in the incidence of postoperative nausea and vomiting was lower, the length of hospital stay was shorter in the observation group( χ2=4.630, t=3.311, P=0.031, 0.002), and the other indicators had no statistical differences(all P>0.05). Conclusions:Multimodal low-opioid combined with saphenous nerve block analgesia can significantly reduce perioperative pain in elderly patients undergoing knee arthroplasty, improve early postoperative mobility, and speed up postoperative functional recovery.

Effects of dezocine combined with sufentanil on continuous epidural analgesia after cesarean section / 中国基层医药

Objective:To investigate the effects of dezocine combined with sufentanil on continuous epidural analgesia after cesarean section.Methods:Eighty-six pregnant women who were scheduled for cesarean section in Guoyang Hospital of Traditional Chinese Medicine from February to December 2021 were included in this randomized controlled study. These women were divided into an observation group and a control group ( n = 43/group). The women in the observation group underwent epidural analgesia with dizocine, sufentanil, and ropivacaine, while those in the control group underwent epidural analgesia with dizocine and ropivacaine. The visual analogue score, Ramsay sedation score, Bruggrmann comfort scale score, and the incidence of adverse reactions were compared between the two groups. Results:At 4, 8, 12, 24 hours after surgery, the visual analogue score (VAS) in the observation group was significantly lower than that in the control group ( t = 2.34, 5.89, 15.36, 16.23, all P < 0.05). At 4, 8, 12, and 24 hours after surgery, Ramsay sedation score in the observation group was significantly higher than that in the control group ( t = -6.31, -7.64, -7.49, -7.41, all P < 0.001). At 4, 8, 12, and 24 hours after surgery, Bruggrmann comfort scale score in the observation group was significantly higher than that in the control group ( t = -7.60, -10.40, -14.53, -13.80, all P < 0.001). There was a significant difference in the number of effective analgesic pump compressions between the observation and control groups [(3.00 ± 1.41) times vs. (7.23 ± 1.31) times, t = 14.42, P < 0.001]. No adverse reactions were observed in the observation group within 24 hours after surgery. Conclusion:Dezocine combined with sufentanil for epidural analgesia can effectively improve the analgesic effects after cesarean section and is highly safe.

Analgesic effect and safety of using an epidural analgesia pump versus an intravenous analgesia pump for uterine artery embolization in the treatment of uterine fibroids / 中国基层医药

Objective:To investigate the analgesic effect and safety of using an epidural analgesia pump versus an intravenous analgesia pump for uterine artery embolization in the treatment of uterine fibroids. Methods:Fifty patients with uterine fibroids undergoing uterine artery embolization admitted to The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University from January 2019 to December 2021 were included in this study. They were divided into an observation group and a control group ( n = 25/group). Patients in the observation group used an epidural analgesia pump for pain relief, while patients in the control group used an intravenous analgesia pump for pain relief. At 1, 6, 12, and 24 hours after surgery, pain severity was compared between the two groups using the Visual Analogue Scale. Comfort level was compared between the two groups using the Bruggemann Comfort scale. Before and after surgery, respiratory rate, heart rate, blood pressure, and adverse reactions were compared between the two groups. Results:At 1 hour after surgery, the Visual Analogue Scale score in the observation group was significantly lower than that in the control group [3.00 (2.00, 5.50) vs. 7.00 (6.00, 8.00), Z = -3.84, P < 0.05]. At 6, 12, and 24 hours after surgery, there was a significant difference in the Visual Analogue Scale score between the two groups (all P > 0.05). Within 24 hours after surgery, the use of opioid analgesics in the observation group was less than that in the control group [16.00% (4/25) vs. 88.00% (22/25), χ2 = 25.96, P < 0.001]. At 1 hour after surgery, the Bruggemann Comfort Scale score in the observation group was significantly higher than that in the control group [0.00 (0.00, 0.50) vs. 0.00 (0.00, 0.00), Z = 2.08, P < 0.05]. At 6, 12, and 24 hours after surgery, there was no significant difference in the Bruggemann Comfort Scale score between the two groups (all P > 0.05). After surgery, heart rate was significantly decreased in each group compared with before surgery (both P < 0.05). There were no significant differences in respiratory rate and mean arterial pressure between the two groups before and after surgery (both P > 0.05). There were no significant differences in the incidences of postoperative nausea, vomiting, and fever between the two groups (all P > 0.05). Conclusion:The epidural analgesia pump used for uterine artery embolization in the treatment of uterine fibroids has a better analgesic effect and provides more comfort and is safer than the intravenous analgesia pump. The former is worthy of clinical promotion.

Pattern of analgesic use for post-operative pain relief among adult surgical patients in a tertiary care hospital

Background: Post-operative pain is an acute pain which if not adequately managed may lead to morbidity and complications. It can be controlled effectively by analgesics. It is essential to choose an analgesic with good efficacy and safety profile to avoid drug-related complications. Aims and Objectives: This study aims (i) to study the pattern of analgesic use for postoperative pain; (ii) to study the efficacy of the analgesic prescribed for post-operative pain; and (iii) to study the safety of the analgesics used for post-operative pain. Materials and Methods: A prospective observational study was conducted for 3 months period. The pattern of analgesic use for post-operative pain was studied in 110 patients. The influence of sociodemographic factors, surgery related factors on pain assessment score, and patient satisfaction score was assessed. The safety profile of analgesics used was studied. Results: Post-operative was seen equally in both the genders and mean age of patients was 41 years. Diclofenac was the most common analgesic prescribed and intramuscular route was most commonly used. About 64% of patients were satisfied with their treatment and 94.55% of patients did not encounter any adverse effects. However, there was no association between various factors and pain assessment score and patient satisfaction score. Conclusion: Post-operative pain can be effectively managed by non-opioid analgesics like diclofenac which provide cost-effective treatment. Analgesic for post-operative pain should be chosen judiciously by considering patient-related and surgery-related factors for better post-operative pain management and to prevent post-operative complications.

Estratégias para manejo e prevenção da síndrome de abstinência em pacientes pediátricos críticos: revisão sistemática / Strategies for the management and prevention of withdrawal syndrome in critically ill pediatric patients: a systematic review

RESUMO Objetivo: Verificar as estratégias de prevenção e tratamento da síndrome de abstinência em unidade de terapia intensiva pediátrica. Métodos: Trata-se de revisão sistemática nas bases de dados PubMed®, Lilacs, Embase, Web of Science, Cochrane, Cinahl, Cochrane Database Systematic Review e CENTRAL. Uma estratégia de busca em três etapas foi utilizada para esta revisão. O protocolo da revisão foi aprovado no PROSPERO (CRD42021274670). Resultados: Foram incluídos na análise 12 artigos. Observou-se grande heterogeneidade entre os estudos incluídos, principalmente em se tratando de esquemas terapêuticos utilizados na sedação e na analgesia. As doses de midazolam variaram de 0,05mg/kg/hora a 0,3mg/kg/hora. A morfina também variou consideravelmente, de 10mcg/kg/hora a 30mcg/kg/hora entre os estudos. A escala mais utilizada para identificação da síndrome de abstinência, entre os 12 estudos selecionados, foi a Sophia Observational Widrawal Symptoms Scale. Em três estudos, houve diferença estatística relevante na prevenção e no manejo da síndrome de abstinência com a implantação de protocolos (p < 0,01 e p < 0,001). Conclusão: Observou-se grande variação entre o regime de sedoanalgesia utilizado entre os estudos e o método de desmame e avaliação de síndrome de abstinência. São necessários mais estudos para fornecer evidências mais robustas acerca do tratamento mais indicado para prevenção e redução dos sinais e sintomas de abstinência em crianças criticamente doentes. Registro PROSPERO:CRD 42021274670

ABSTRACT Objective: To verify strategies for the prevention and treatment of abstinence syndrome in a pediatric intensive care unit. Methods: This is a systematic review in the PubMed database®, Lilacs, Embase, Web of Science, Cochrane, Cinahl, Cochrane Database Systematic Review and CENTRAL. A three-step search strategy was used for this review, and the protocol was approved in PROSPERO (CRD42021274670). Results: Twelve articles were included in the analysis. There was great heterogeneity among the studies included, especially regarding the therapeutic regimens used for sedation and analgesia. Midazolam doses ranged from 0.05mg/kg/hour to 0.3mg/kg/hour. Morphine also varied considerably, from 10mcg/kg/hour to 30mcg/kg/hour, between studies. Among the 12 selected studies, the most commonly used scale for the identification of withdrawal symptoms was the Sophia Observational Withdrawal Symptoms Scale. In three studies, there was a statistically significant difference in the prevention and management of the withdrawal syndrome due to the implementation of different protocols (p < 0.01 and p < 0.001). Conclusion: There was great variation in the sedoanalgesia regimen used by the studies and the method of weaning and evaluation of withdrawal syndrome. More studies are needed to provide more robust evidence about the most appropriate treatment for the prevention and reduction of withdrawal signs and symptoms in critically ill children. PROSPERO register: CRD 42021274670

Opioid consumption and prescription in Brazil: integrative review / Uso e prescrição de opioides no Brasil: revisão integrativa

ABSTRACT BACKGROUND AND OBJECTIVES: In the past twenty years, the number of deaths caused by opioid overdose has tripled in the United States. There is, in literature, a scarcity of up-to-date evidence regarding opioids consumption in the Brazilian scenario. The objectives of this study was to know, through a literary review, the pattern of opioid analgesics consumption in Brazil. METHODS: An integrative review of the literature, performed in the PubMed, BVS and Scielo databases from August 30 to October 22, 2020. The search strategy included the following terms, "Opioid-related disorders" or "Opioid epidemic" or "Opioid analgesics" and "Brazil". Inclusion criteria: published in the last five years; studies on humans. Exclusion criteria: studies not related to the objective of this review; letters, editorials, commentaries and secondary studies. RESULTS: The results showed patients' dissatisfaction with pain management when compared to patients from developed countries, the lack of knowledge and adequate public policies on the use of opioids among health professionals make them view opioids as the last treatment alternative. The practice of analgesic self-medication is frequent in patients with chronic diseases, which may be the cause of the low prescription of opioid analgesics by health professionals. CONCLUSION: It is noteworthy that there is a lack of data related to the prescription and use of opioids in Brazil. Further studies should be conducted to assess the use of opioids in general medical practice.

RESUMO JUSTIFICATIVA E OBJETIVOS: Nos últimos 20 anos, o número de mortes causadas por overdose de opioides triplicou nos Estados Unidos. São escassas na literatura evidências atualizadas sobre o consumo de opioides no cenário brasileiro. O objetivo deste estudo foi conhecer, por meio de revisão literária, o padrão de consumo de analgésicos opioides no Brasil. MÉTODOS: Revisão integrativa da literatura, realizada nas bases de dados Pubmed, BVS e Scielo, no período de 30 de agosto a 22 de outubro de 2020. A estratégia de busca incluiu os termos "Transtornos relacionados ao uso de opioides" ou "Epidemia de opioides" ou "Analgésicos opioides" e "Brasil". Critérios de inclusão: publicação nos últimos cinco anos; estudos em humanos. Critérios de exclusão: estudos não relacionados ao objetivo desta revisão; cartas, editoriais, comentários e estudos secundários. RESULTADOS: Os resultados mostraram a insatisfação dos pacientes com o manejo da dor quando comparados a pacientes de países desenvolvidos, a falta de conhecimento e de políticas públicas adequadas sobre o uso de opioides entre os profissionais de saúde faz com que estes vejam os opioides como a última alternativa de tratamento. A prática da automedicação analgésica é frequente em pacientes com doenças crônicas, o que pode ser a causa da baixa prescrição de analgésicos opioides pelos profissionais de saúde. CONCLUSÃO: Faltam dados relacionados à prescrição e uso de opioides no Brasil. Novos estudos devem ser realizados para avaliar o uso de opioides na prática médica geral.

Self-medication practices with conventional and herbal drugs among ear, nose, and throat patients

SUMMARY OBJECTIVE: This study evaluates the self-practices with conventional and herbal drug use among ear, nose, and throat outpatients. METHODS: A cross-sectional survey-based study was carried out among all ear, nose, and throat outpatients on their first visit to the otorhinolaryngology department at a tertiary care hospital. The survey comprised a total of 14 questions with 4 different sections, including demographic characteristics, self-medication of conventional medicines, herbal medication usage, and perception regarding herbal medicines. RESULTS: Overall, 255 questionnaires were distributed among patients, of which 183 completed the questionnaire (response rate=71.7%). Respondents reported self-medication (44.8%) with conventional drugs before visiting a hospital. The most commonly used medicine was analgesics (31.7%) and antibiotics (21.9%). Nearly half of the patients (49.2%) used at least one herbal drug. The most commonly used herbal medications were Tilia cordata (78.8%), Zingiber officinale (62.2%), and Camellia sinensis (45.5%). According to the International Union for Conservation of Nature Red List, most of the medicinal herbs were considered as data deficient/least concern. About 36.6% of the participants perceived that herbal drugs are effective for ear, nose, and throat problems. Moreover, 22.9% of the patients did not know about herbal-drug interaction with other medications. CONCLUSIONS: This study observed a considerable prevalence of self-based practices with conventional and herbal medications. Strict national regulations on conventional and herbal medication access and long-term actions should be implemented to discourage inappropriate drug use.