Self-medication with analgesics reported by patients with ulcerative colitis: An anonymous survey.

INTRODUCTION: Analgesics are widely used, but evidence regarding whether their use increases the risk of inflammatory bowel disease (IBD) flares or complications is unclear. Therefore, self-medication with analgesics in IBD is usually not recommended. The aim of this study was to explore the prevalence of self-medication with analgesics in a cohort of ulcerative colitis (UC) patients and to identify reasons and factors associated with self-medication. METHODS: This cross-sectional study included consecutive unselected adult patients with UC. Participants were asked to complete an anonymous web-based survey with multiple-choice questions and closed responses. No clinical data were collected. RESULTS: A total of 546 patients (61.2% women, mean age 39.9 years) completed the survey. The prevalence of self-medication with analgesics was 49.8% (272/546). Paracetamol (45.2%) and metamizole (21.2%) were the most frequently used drugs; frequencies of self-medication were <5% for other analgesics (nonsteroidal anti-inflammatory drugs, opioids). The most frequent reasons for self-medication were the need for quick symptom relief and that it had been agreed with/prescribed by the treating physician. Multivariable analysis identified female sex (odds ratio [OR]=1.9), sick leave (OR=2.2), treatment with intravenous drugs (OR=2.9), and emergency room visit (OR=2.3) as variables associated with self-medication, whilst follow-up by a nurse was associated with less self-medication (OR=0.6). CONCLUSION: The frequency of self-medication with analgesics in UC patients is high and appears to be associated with variables suggesting worse disease control. Closer follow-up, including a specialized nurse, could decrease self-medication. Strategies to improve disease control, including close monitoring of symptoms such as pain, are needed.

Caffeine and headache: specific remarks. / Cafeína y cefalea: consideraciones especiales.

Caffeine is the most widely used psychostimulant worldwide. Excessive caffeine consumption induces a series of both acute and chronic biological and physiological changes that may give rise to cognitive decline, depression, fatigue, insomnia, cardiovascular changes, and headache. Chronic consumption of caffeine promotes a pro-nociceptive state of cortical hyperexcitability that can intensify a primary headache or trigger a headache due to excessive analgesic use. This review offers an in-depth analysis of the physiological mechanisms of caffeine and its relationship with headache.

[Pharmacist perception of the use of analgesics and their practice on mild-moderate pain. DOLOR-OFF survey]. / Percepción farmacéutica del uso de analgésicos y su práctica en dolor leve-moderado. Encuesta DOLOR-OFF.

OBJECTIVE: To examine the use of analgesics, from the perspective of the pharmacist community, and pharmaceutical practice in mild-moderate pain. DESIGN: A cross-sectional, observational study was performed between April and September 2013. SETTING: 696 community pharmacies in 20 Spanish provinces. PARTICIPANTS: Community pharmacists with a minimum professional experience of one year. MAIN MEASUREMENTS: Characterisation of the demand for analgesics, analgesic users, and pharmaceutical intervention for mild-moderate pain from the perspective of the pharmaceutical community. RESULTS: The main reason why a patient with mild-moderate pain visits a pharmacy is to receive a drug with prescription (45.5%), and the most common condition is headache (35.2%). Ibuprofen and paracetamol are the most commonly used drugs for mild-moderate pain. More than one-third (38.9%) of pharmacists follow a protocol for counselling. A correlation was found between the pharmacist's professional experience and the application of counselling process (Fisher P<.05). Some 87.8% of pharmacists checked two indicators from the dispensing service, and only 1.3% did not check any. Referral to a physician was made by 14.8% of pharmacists, with the main reason being the detection of alarm indicators. CONCLUSIONS: Protocols need to be designed and adapted to the characteristics of the 3 profiles identified, in order to increase the efficiency of pharmaceutical services in mild-moderate pain relief. Practical and specific training in pain are required to implement services to ensure the correct and systemic use of analgesics and positive clinical outcomes.

[Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial]. / Colecistectomía laparoscópica ambulatoria por minilaparoscopia versus colecistectomía laparoscópica ambulatoria multipuerto tradicional. Estudio prospectivo aleatorizado.

OBJECTIVE: Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. METHODS: Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. RESULTS: Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). CONCLUSIONS: MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery.

[Observational and cross-sectional study of prevalence and severity of the opioid-induced bowel dysfunction]. / Prevalencia y severidad de la disfunción intestinal inducida por opioides.

OBJECTIVE: To analyze the prevalence and severity of the opioid-induced bowel dysfunction (OBD) symptoms. DESIGN: Epidemiological, observational and cross-sectional study. LOCATION: Six Spanish centers participated. PARTICIPANTS: A total of 317 outpatients with a diagnosis of cancer pain or non-cancer pain treated with a unique opioid were recruited. MAIN MEASUREMENTS: The prevalence of OBD symptoms was measured using a visual analog scale (VAS: 0-100), and constipation was also assessed by the Bowel Function Index (BFI). The treatment for gastrointestinal symptoms was recorded, and the frequency of symptoms between different opioid treatments was compared. Finally, quality of life was evaluated. RESULTS: The prevalence of OBD with at least one gastrointestinal disorder was 94.6%, with constipation being the most frequent symptom (BFI: 91.6%; VAS: 90.2%) and nearly half of the patients showed three or more symptoms with a VAS ≥ 4. No significant differences were detected in the prevalence of symptoms between the opioid groups. A decrease in the wellbeing of patients was detected related to moderate to severe gastrointestinal symptoms. CONCLUSIONS: A high rate of gastrointestinal disorders probably related to OBD have been confirmed in patients on opioid therapy, highlighting the need for new drug strategies.

[Treatment of patients with osteoarthritis]. / Tratamiento del paciente con artrosis.

The therapeutic management of patients with osteoarthritis aims to decrease pain and inflammation, improve physical function, and to apply safe and effective treatments. A patient-centered approach implies the active participation of the patient in the design of the treatment plan and in timely and informed decision-making at all stages of the disease. The nucleus of treatment is patient education, physical activity and therapeutic exercise, together with weight control in overweight or obese patients. Self-care by the individual and by the family is fundamental in day-to-day patient management. The use of physical therapies, technical aids (walking sticks, etc.) and simple analgesics, opium alkaloids, and antiinflammatory drugs have demonstrated effectiveness in controlling pain, improving physical function and quality of life and their use is clearly indicated in the treatment of osteoarthritis. Conservative surgery and joint replacement is indicated when treatment goals are not achieved in specific patients.

[Translated article] Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project.

OBJECTIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project. / Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN.

OBJETIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Clinical differences in a multidisciplinary pediatric pain unit between primary and secondary chronic pain.

INTRODUCTION: Chronic pain affects an important part of the pediatric population in developed countries. secondary chronic pain (SCP) can have a well-defined medical cause, but primary chronic pain (PCP) can have an unknown etiology. In Spain, there is as yet no information on the clinical differences between patients treated in multidisciplinary units. METHODS: Retrospective analysis of the clinical records of patients seen in 2018 at the Children's Chronic Pain Unit in University La Paz Hospital. RESULTS: A total of 92 patients were included, (age between 3 and 19 years), with a mean age of 12.4 (SD = 4.1) years, mostly female (55%), with a mean duration of pain of 11.3 (SD = 10.4) months. A comparison of patients with PCP (n = 31) and SCP (n = 61) showed that both groups, on average, presented intense pain (X = 5.9; SD = 2.2; range = 0-10), with similar duration and functional repercussions, although PCP was less likely to be associated with neuropathic descriptors than SCP (p = 0.040), and was more extensive (p < 0.001). Both groups received similar treatment, based on rehabilitation, psychotherapy, invasive techniques and analgesic medication, although patients in the PCP group received less analgesic medication (gabapentinoids and opioids) than the SCP (p = 0.011). CONCLUSION: Patients treated in a multidisciplinary Child Pain Unit for PCP or SCP present a very similar clinical profile, though with differences in the number and type of analgesic drugs used. This shows the importance of etiologic diagnosis for adequate pharmacological treatment.

Factors associated with all-cause mortality at 90 days in hospitalized adult patients who received parenteral nutrition.

Introduction: Objective: this study aimed to assess the main factors related to mortality in a cohort of hospitalized adult patients who required parenteral nutrition (PN) considering their characteristics, type of admission, procedures, nutritional data, and adverse events. Methods: a retrospective study was performed in a 400-bed university hospital. All adult inpatients that had received ≥ 4 days as first course of PN within 24 months were included. Patients with long-term (> 90 days) or home PN were excluded. The main variable was all-cause mortality at 90 days after the end of PN. Initial independent variables were anthropometric and demographic data, admission characteristics, severity, comorbidity, surgical/medical procedures, baseline biochemical parameters, nutritional risk, and other nutritional data, medications, and adverse events during PN. A Cox proportional hazards regression model was planned to analyze time-to-event data. Results: a total of 634 patients entered the study and 140 (22.1 %) died. Patients were mainly: surgical 471 (74.3 %), male 393 (62.0 %), and age 69.0 (67.8-70.1) years old. The survival time for the entire cohort was 74.0 (95 % CI: 71.6-76.6) days. The final model included 14 variables, with severity and comorbidity being the main ones, but including also anastomotic suture dehiscence, sepsis during PN, days with hyperglycemic events, use of potent opioids, failed attempts at enteral nutrition, and, as a protective one, energy provided in PN. Conclusions: the factors related to mortality in hospitalized adult patients who required PN were mainly severity and comorbidities, but several other important factors were also relevant and could be modified to maximize outcomes in these patients.

Introducción: Objetivo: valorar los factores relacionados con la mortalidad en una cohorte de pacientes adultos hospitalizados que recibieron nutrición parenteral (NP) atendiendo a sus características, procedimientos, parámetros nutricionales y complicaciones. Métodos: estudio retrospectivo realizado en un hospital universitario de 400 camas. Se incluyeron todos los pacientes adultos que recibieron ≥ 4 días de NP en un periodo de 24 meses. Se excluyeron los pacientes con NP de largo plazo (> 90 días) o NP domiciliaria. La variable principal fue la mortalidad por cualquier causa en los 90 días posteriores al fin de la NP. Las variables independientes iniciales fueron los datos antropométricos y demográficos, el tipo de ingreso, la gravedad, la comorbilidad, los procedimientos médicos/quirúrgicos, los parámetros bioquímicos, el riesgo nutricional, otros parámetros nutricionales, las medicaciones y los eventos adversos durante la NP. Se realizó un análisis de supervivencia por el modelo de los riesgos proporcionales de Cox. Resultados: en total, 634 pacientes entraron en el estudio, de los cuales 140 (22,1 %) murieron. Los pacientes fueron principalmente: quirúrgicos 471 (74,3 %), hombres 393 (62,0 %) y de 69,0 (67,8-70,1) años de edad. La supervivencia de toda la cohorte fue de 74,0 (IC 95 %: 71,6-76,6) días. El modelo final incluyó 14 variables. La gravedad y la comorbilidad fueron las principales, pero también resultaron incluidas la dehiscencia de la sutura, la sepsis, los días con hiperglucemia, los intentos fallidos de nutrición enteral, el uso de opiáceos potentes y, como protector, la energía administrada en la NP. Conclusión: los factores relacionados con la mortalidad en estos pacientes con NP fueron principalmente la gravedad y la comorbilidad, pero otros factores también fueron relevantes y podrían ser modificados para maximizar los resultados en salud.

Strong opioids and non-cancer chronic pain in Catalonia. An analysis of the family physicians prescription patterns. / Opioides fuertes y dolor crónico no oncológico en Cataluña. Análisis del patrón de prescripción por parte de los médicos de familia.

OBJECTIVE: To identify family doctor prescription patterns for strong opioids for chronic, non-cancer-related pain. MATERIALS AND METHODS: Design A descriptive study based on a self-administered email questionnaire. LOCATION: All primary health care centres in Catalonia. PARTICIPANTS: 3,602 family doctors, all members of the Catalan Society of Family and Community Medicine. INTERVENTIONS: Email survey of Catalan family doctors. MAIN MEASUREMENTS: Demographic data, number of patients treated with potent opioids for chronic non-cancer pain, type of opioid used and indications, prescribing patterns and relationship with the Pain Management Unit. RESULTS: A total of 551 answers were obtained from 3,602 questionnaires sent (response rate of 15.3%), in which 480 physicians (87%) prescribed strong opioids for musculoskeletal pain, 268 (48.6%) prescribed ultra-rapid fentanyl and 434 (78.7%) reduced benzodiazepines dosage when prescribing potent opioids. The most common adverse effects were constipation and nausea. The main problems related with opioid prescription were improper use (341, 71%) and patient and/or practitioner reluctance (87, 18.1%). The assessment of the relationship with Pain Management Units was 2±1 (on a 1 to 5 scale), with communication (271, 52.2%) and accessibility (141, 27.1%) being the areas most in need of improvement. CONCLUSIONS: Opioid prescribing patterns generally follow clinical guidelines (e.g. reduction of benzodiazepine use or dose titration). However, there are some areas of improvement, such as sparse use of laxatives or use of ultra-rapid opioids for unapproved indications and in patients with no background opioid therapy. Family doctors perceive patient reluctance to adhere to the prescribed treatment, and call for specific training and better relationships with Pain Management Units.

Uso de analgésicos não opioides entre estudantes de Enfermagem no Amazonas, Brasil / Uso de analgesicos no-opioides entre estudiantes de Enfermería em Amazonas, Brasil / Use of non-opioid analgesics among nursing students in the Amazonas, Brazil

Objetivo: Estimar a prevalência do uso de analgésicos não opioides para alívio da dor entre graduandos de Enfermagem. Método: Estudo transversal, realizado com 142 estudantes de Enfermagem no interior do estado do Amazonas, Região Norte do Brasil. Os dados foram coletados no segundo semestre de 2017, utilizando questionário autoaplicável. Resultados: A prevalência do consumo de analgésicos não opioides foi de 68,3%; sendo o alívio das dores de cabeça (64,9%) e dores abdominais (14,4%) os principais motivos para uso. A maioria afirmou que: a dor interfere na realização de atividades diárias (77,3%); reconhecem que os analgésicos podem fazer mal à saúde (76,3%); consumiam analgésicos por conta própria (58,8%). Ainda, 47,4% indicavam medicamentos a terceiros e 93,8% estocavam medicamentos em suas casas. Conclusão: Constatou-se elevado consumo de analgésico, destacando o uso irracional -sem prescrição de profissional. Faz-se necessário fortalecer o ensino sobre o uso racional de medicamentos entre os alunos de Enfermagem, visando minimizar os riscos desta prática.

Objetivo: Estimar la prevalencia de analgésicos no opioides para el alivio del dolor entre los estudiantes de enfermería. Método: Estudio transversal, realizado con 142 estudiantes de enfermería en el interior del estado de Amazonas, Región Norte de Brasil. Los datos se recopilaron en el segundo semestre de 2017 utilizando un cuestionario autoadministrado. Resultados: La prevalencia del uso analgésico no opioide fue del 68,3%; ser el alivio de los dolores de cabeza (64,9%) y dolor abdominal (14,4%) las principales razones de uso. La mayoría declaró que: el dolor interfiere con el desempeño de las actividades diarias (77,3%); reconocen que los analgésicos pueden dañar la salud (76,3%); consumieron analgésicos por sí solos (58,8%). Además, el 47,4% reportó medicamentos a terceros y el 93,8% dijo que almacenaba los medicamentos en sus hogares. Conclusión: Hubo un alto consumo de analgésicos, destacando el uso irracional ­sin prescripción profesional. Es necesario fortalecer la enseñanza sobre el uso racional de los medicamentos entre los estudiantes de enfermería, con el objetivo de minimizar los riesgos de esta práctica.

Objective: To estimate the prevalence of non-opioid analgesics for pain relief among nursing undergraduates. Method: Cross-sectional study, conducted with 142 nursing students in the interior of the state of Amazonas, Northern Region of Brazil. Data were collected in the second half of 2017 using a self-administe redquestionnaire. Results: The prevalence of non-opioid analgesic use was 68,3%; being the relief of headaches (64,9%) and abdominal pain (14,4%) the main reasons for use. The majority stated that: pain interferes with the performance of daily activities (77.3%); they recognize that analgesics can harm health (76.3%); they consumed analgesics on their own (58.8%). Still, 47.4% indicated medicines to third parties and 93.8% reported that they stocked medicines in their homes. Conclusion: There was a high consumption of analgesics, highlighting irrational use -without professional prescription. It is necessary to strengthen the teaching on the rational use of medicines among nursing students, aiming to minimize the risks of this practice.

[The use of analgesics and risk of self-medication in an urban population sample: cross-sectional study]. / Uso de analgésicos e o risco da automedicação em amostra de população urbana: estudo transversal.

BACKGROUND AND OBJECTIVES: There are few data in the literature characterizing the pattern of analgesic use in Latin American countries, including Brazil. Little is known about the undertreatment of pain and its influence on the habit of self-medication with analgesics. The aim of this study is to define the pattern of analgesic use among chronic pain patients and its potential association with self-medication with analgesics. METHOD: Cross-sectional observational study with an urban population sample. Chronic pain was defined as a pain lasting for at least 90 days. The study was approved by the Research Ethics Committee of the institution. RESULTS: 416 subjects were included; 45.7% (n=190) had chronic pain, with females (72.3%; p=0.04) being the most affected. Self-medication with analgesics is practiced by 78.4% of patients with chronic pain. The most common current analgesic treatment consists of non-steroidal anti-inflammatory drugs (dipyrone and acetaminophen). Weak opioids are rarely used and only 2.6% of subjects with chronic pain were taking these analgesics. None of the subjects were taking potent opioids. CONCLUSIONS: The practice of self-medication with analgesics is frequent among patients with chronic pain, which may be due to the underprescription of more potent analgesics, such as opioids. It can also be said that, given the data presented, there is no crisis of recreational opioid use in the studied population.

Anestesia libre de opioides en cirugía bariátrica laparoscópica

Introducción: La anestesia libre de opioides surge de las alternativas farmacológicas que permiten otra opción anestésica en el arsenal del anestesiólogo. Objetivo: Evaluar la efectividad y seguridad de una técnica anestésica libre de opioides en el paciente intervenido con cirugía bariátrica laparoscópica. Métodos: Se realizó un estudio observacional analítico, prospectivo y longitudinal en 23 pacientes operados con anestesia general multimodal libre de opioides. Pacientes mayores de 18 años con un índice de masa corporal mayor o igual a 35 kg/m2, con estado físico ASA II y III. Se evaluó la analgesia posoperatoria e intraoperatoria como una necesidad de la analgesia de rescate en el tiempo de recuperación y los efectos adversos. Resultados: Se demostró que la edad promedio fue 38,19 ± 8,73 con un predominio en el sexo femenino, los pacientes fueron clasificados como ASA II y obesos grados III. Hubo una estabilidad hemodinámica intraoperatoria. El 82,6 % de los pacientes no presentaron dolor posoperatorio en las primeras 24 h. No se presentaron pacientes con dolor severo. Requirieron analgesia de rescate cinco pacientes (21,7 %) en posoperatorio, y las complicaciones fueron escasas sin repercusión clínica. El tiempo promedio para la extubación fue de 6,7 ± 0,8 min y la recuperación total de 29,6 ± 0,8 min. Conclusiones: La técnica multimodal libre de opioides resultó segura y efectiva, con un adecuado estado de analgesia perioperatoria y escasas complicaciones en los pacientes intervenido con cirugía bariátrica laparoscópica.

Introduction: Opioid-free anesthesia arises from pharmacological alternatives that allow another anesthetic option in the anesthesiologist's arsenal. Objective: To evaluate the effectiveness and safety of an opioid-free anesthetic technique in patients undergoing laparoscopic bariatric surgery. Methods: An analytical, prospective and longitudinal observational study was carried out in 23 patients operated on with opioid-free multimodal general anesthesia. The patients studied were over 18 years of age, with a body mass index greater than or equal to 35 kg/m2, ASA physical status II and III. Postoperative and intraoperative analgesia were evaluated as a need for rescue analgesia in recovery time and adverse effects. Results: It was shown that the average age was 38.19 ± 8.73 with a predominance in the female sex, the patients were classified as ASA II and grade III obese. There was intraoperative hemodynamic stability. 82.6% of patients did not experience postoperative pain in the first 24 hours. There were no patients with severe pain. Five patients (21.7%) required rescue analgesia postoperatively, and complications were rare without clinical repercussions. The average time for extubation was 6.7 ± 0.8 min and total recovery was 29.6 ± 0.8 min. Conclusions: The opioid-free multimodal technique was safe and effective, with adequate state of perioperative analgesia and few complications in patients undergoing laparoscopic bariatric surgery.

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.

Asociación entre impulso respiratorio y profundidad de sedación en sujetos bajo ventilación mecánica invasiva: estudio observacional / Association between respiratory drive and depth of sedation in subjects under invasive mechanical ventilation: an observational study

RESUMEN Objetivo: El objetivo de este estudio es determinar si existe asociación entre el impulso respiratorio, evaluado a través de la presión de oclusión (P0.1), y la profundidad de sedación, medida a través de la escala de agitación-sedación de Richmond (RASS, por sus siglas en inglés), en sujetos adultos sometidos a ventilación mecánica invasiva e internados en la unidad de cuidados intensivos del Hospital de Clínicas José de San Martín (HCJSM) en Buenos Aires. Como objetivo secundario, se planteó analizar el comportamiento de variables que pudieran tener impacto en el impulso respiratorio. Materiales y método: Se realizó un estudio observacional en un hospital universitario de la Ciudad Autónoma de Buenos Aires entre el 1 de abril de 2023 y el 28 de mayo de 2023. Las variables analizadas fueron P0.1, RASS, dolor, delirio, exposición a analgésicos y sedantes, estado ácido-base, presión arterial de oxígeno/fracción inspirada de oxígeno (PaO2/FiO2), evaluación de falla orgánica relacionada con la sepsis (SOFA, por sus siglas en inglés) e índice de masa corporal (IMC). Resultados: Se recolectaron 71 mediciones correspondientes a 33 sujetos. La mediana de P0.1 fue de 0,13 cmH20 (0-0,97). En el análisis univariado, se encontró una asociación inversamente proporcional entre la P0.1 y el puntaje RASS (β=-0,4068 y p=0,0435). Los resultados del análisis multivariado mostraron que ninguna de las variables contempladas se asoció con la P0.1 cuando fueron ajustadas entre sí. Conclusión: En este estudio, encontramos una asociación entre la P0.1 y el puntaje RASS, así como una asociación independiente entre la P0.1 y la exposición a la combinación de analgesia y sedación. Sin embargo, al ajustar estas variables en el análisis multivariado, no se encontró asociación.

ABSTRACT Objective: The objective of this study is to determine whether there is an association between respiratory drive, assessed through P0.1, and depth of sedation, measured through the Richmond agitation-sedation scale (RASS), in adult subjects undergoing invasive mechanical ventilation and admitted to the intensive care unit of Hospital de Clínicas José de San Martín (HCJSM) in Buenos Aires. As a secondary objective, we aim to analyze the behavior of variables that may have an impact on respiratory drive. Materials and method: An observational study was conducted at a university hospital in the Autonomous City of Buenos Aires between April 1, 2023, and May 28, 2023. The analyzed variables included P0.1, RASS, pain, delirium, exposure to analgesics and sedatives, acid-base status, pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2), sepsis-related organ failure assessment (SOFA), and body mass index (BMI). Results: A total of 71 measurements were collected from 33 subjects. The median P0.1 was 0.13 cmH20 (0-0.97). In the univariate analysis, an inversely proportional association was found between P0.1 and RASS score (β=-0.4068 and p=0.0435). The results of the multivariate analysis showed no association between P0.1 and any of the considered variables when adjusted for each other. Conclusion: In this study, we found an association between P0.1 and RASS score, along with an independent association between P0.1 and exposure to the combination of analgesia and sedation. However, when adjusting these variables in the multivariate analysis, no association was found.

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.

Política pública en cuidados paliativos y sus implicaciones sobre servicios, opioides y educación en Colombia / Public policy on palliative care and its implications for services, opioids, and education in Colombia

Introducción: El desarrollo de cuidados paliativos exige la intervención de múltiples dimensiones de salud pública, incluyendo la disponibilidad de servicios de salud, medicamentos esenciales y programas educativos. En Colombia se han realizado diversos cambios en las políticas públicas para promover la atención de personas con necesidades paliativas. Objetivo: Evaluar empíricamente las políticas públicas, existentes en cuidados paliativos y sus implicaciones sobre disponibilidad de servicios, opioides y programas educativos en los años 2010 ­ 2019 en Colombia. Materiales y métodos: Se diseñó un estudio mixto exploratorio secuencial en tres fases: identificación de indicadores empíricos de políticas nacionales, diagnostico situacional de cuidados paliativos y evaluación cualitativa de los resultados de la implementación de políticas en siete nodos territoriales de Colombia. Resultados: Se revisaron siete normas obteniendo 12 indicadores empíricos para la evaluación, seis de ellos no contaban con fuentes de información. El diagnostico nacional evidencia un aumento gradual de servicios y consumo de opioides en los años hito del desarrollo de políticas. 44 profesionales de cuidados paliativos perciben un efecto positivo de las políticas públicas en el consumo de opioides y bajos resultados para el dominio de servicios y educación Conclusiones: Existe una relación positiva entre políticas públicas y consumo de opioides, una relación cuantitativa positiva para servicios de cuidados paliativos y una relación cuanticualitativa negativa para programas educativos, lo que denota un bajo estatus operativo de las políticas construidas para mejorar el dolor y sufrimiento asociado a la enfermedad crónica avanzada.

Introduction: Palliative care development requires the intervention of multiple dimensions of public health, including the availability of health services, essential medicines, and educational programs. In Colombia, several changes have been made in public policy to promote the care of people with palliative needs. Objective: To empirically evaluate existing public policies on palliative care and their implications for the availability of services, opioids, and educational programs during the years 2010 to 2019 in Colombia. Materials and methods: A mixed sequential exploratory study was designed in three phases: identification of empirical indicators of national policies, palliative care situational diagnosis, and qualitative assessment of the results of policy implementation in seven regional nodes in Colombia. Results: Seven standards were reviewed, yielding 12 empirical indicators for assessment, six of which had no sources of information. The national diagnosis shows a gradual increase in services and opioid use during the landmark years of policy development. Forty-four palliative care professionals perceive a positive effect of public policy on opioid use and low outcomes for service and education domains. Conclusions: There is a positive relationship between public policy and opioid use, a positive quantitative relationship with palliative care services, and a negative quantitative-qualitative relationship with educational programs. This indicates a low operational status of policies designed to alleviate the pain and suffering associated with advanced chronic diseases.

Introdução: O desenvolvimento dos cuidados paliativos requer a intervenção de múltiplas dimensões da saúde pública, incluindo a disponibilidade de serviços de saúde, medicamentos essenciais e programas educativos. Na Colômbia, várias mudanças foram feitas nas políticas públicas para promover o cuidado de pessoas com necessidades paliativas. Objetivo: Avaliar empiricamente as políticas públicas existentes em cuidados paliativos e suas implicações na disponibilidade de serviços, opioides e programas educacionais nos anos 2010 - 2019 na Colômbia. Materiais e métodos: Desenhou-se um estudo misto exploratório sequencial em três fases: identificação de indicadores empíricos de políticas nacionais, diagnóstico situacional de cuidados paliativos e avaliação qualitativa dos resultados da implementação de políticas em sete nodos territoriais da Colômbia. Resultados: Sete normas foram revisadas, obtendo-se 12 indicadores empíricos para avaliação, seis delas não possuíam fontes de informação. O diagnóstico nacional mostra um aumento gradual nos serviços e consumo de opioides nos anos marcantes do desenvolvimento de políticas. 44 profissionais de cuidados paliativos percebem efeito positivo das políticas públicas sobre o consumo de opioides e resultados baixos para o domínio serviços e educação Conclusões: Existe relação positiva entre políticas públicas e consumo de opioides, relação quantitativa positiva para serviços de cuidados paliativos e negativa relação quantitativo-qualitativa para programas educativos, o que denota um baixo status operacional das políticas destinadas a melhorar a dor e o sofrimento associados à doença crônica avançada.

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.