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1.
Arq. ciências saúde UNIPAR ; 27(3): 1269-1283, 2023.
Artículo en Portugués | LILACS | ID: biblio-1425965

RESUMEN

Introdução: A terapia com medicamentos endovenosos é muito utilizada nas unidades hospitalares, porém, possui uma elevada chance de incidentes, principalmente quando os medicamentos são administrados simultaneamente em via Y. Essa prática pode resultar em incompatibilidades medicamentosas classificadas em reações físicas e químicas. Objetivo: Construir e validar uma ferramenta preventiva de incompatibilidade medicamentosa em via Y. Método: Estudo metodológico com abordagem quantitativa. Foi desenvolvido em três etapas: Levantamento bibliográfico, construção e diagramação do material e por fim, a validação da ferramenta preventiva. Para validação, a ferramenta preventiva foi submetida ao processo de validação de face e conteúdo por juízes com expertise na temática. Resultados: Construiu-se e validou-se uma ferramenta preventiva através da busca de dados na literatura com a participação de sete juízes especialistas na temática. Os itens avaliativos referentes a tabela de incompatibilidade medicamentosa quanto aos objetivos, estrutura, apresentação e relevância da ferramenta preventiva foi considerada válida, pois foram julgados como adequado pelos especialistas. Conclusão: A validação de conteúdo, foi considerada válida pelos juízes, portanto, espera-se que o material alcance o seu objetivo ao ser aplicado durante a prática clínica. Dessa forma, será disponibilizado à instituição para que seja utilizado, favorecendo a prevenção de danos e contribuindo para a segurança dos pacientes, bem como melhorando a qualidade da assistência e educação em saúde.


Introduction: Intravenous drug therapy is widely used in hospital units, however, it has a high chance of incidents, especially when drugs are administered simultaneously in a Y route. This practice can result in drug incompatibilities classified into physical and chemical reactions. Objective: To build and validate a preventive tool for drug incompatibility in the Y pathway. Method: Methodological study with a quantitative approach. It was developed in three stages: bibliographic survey, construction and layout of the material and finally, the validation of the preventive tool. For validation, the preventive tool was submitted to the face and content validation process by judges with expertise in the subject. Results: A preventive tool was built and validated through the search for data in the literature with the participation of seven expert judges on the subject. The evaluative items referring to the medication incompatibility table regarding the objectives, structure, presentation and relevance of the preventive tool were considered valid, as they were judged as adequate by the specialists. Conclusion: The content validation was considered valid by the judges, therefore, it is expected that the material reaches its objective when applied during clinical practice. In this way, it will be made available to the institution for use, favoring the prevention of damage and contributing to patient safety, as well as improving the quality of health care and education.


Introducción: La farmacoterapia intravenosa es ampliamente utilizada en las unidades hospitalarias, sin embargo, tiene una alta probabilidad de incidencias, especialmente cuando los fármacos se administran simultáneamente en una vía Y. Esta práctica puede dar lugar a incompatibilidades medicamentosas clasificadas en reacciones físicas y químicas. Objetivo: Construir y validar una herramienta preventiva de incompatibilidad de medicamentos en la vía Y. Método: Estudio metodológico con enfoque cuantitativo. Se desarrolló en tres etapas: relevamiento bibliográfico, construcción y diagramación del material y finalmente, la validación de la herramienta preventiva. Para la validación, la herramienta preventiva fue sometida al proceso de validación facial y de contenido por jueces expertos en el tema. Resultados: Se construyó y validó una herramienta preventiva a través de la búsqueda de datos en la literatura con la participación de siete jueces expertos en el tema. Los ítems evaluativos referentes a la tabla de incompatibilidad de medicamentos en relación a los objetivos, estructura, presentación y relevancia de la herramienta preventiva fueron considerados válidos, pues fueron juzgados como adecuados por los especialistas. Conclusiones: La validación del contenido fue considerada válida por los jueces, por lo tanto, se espera que el material alcance su objetivo al ser aplicado durante la práctica clínica. De esta forma, se pondrá a disposición de la institución para su uso, favoreciendo la prevención de daños y contribuyendo a la seguridad del paciente, además de mejorar la calidad de la atención y educación en salud.


Asunto(s)
Equipo de Laboratorio , Incompatibilidad de Medicamentos , Prevención de Enfermedades , Administración Intravenosa/instrumentación , Preparaciones Farmacéuticas , Educación en Salud , Personal de Salud/organización & administración , Estudios de Validación como Asunto , Seguridad del Paciente , Antiinfecciosos/farmacología
2.
Québec; INESSS; mai 2022.
No convencional en Francés | BRISA/RedTESA | ID: biblio-1516304

RESUMEN

INTRODUCTION: Des études observationnelles réalisées à la fin des années 1970 ont rapporté une augmentation de la survie globale et de la qualité de vie chez des patients atteints de différents types de cancer en phase terminale traités avec des injections de vitamine C à haute dose. D'autres publications ont rapporté que les niveaux plasmatiques de vitamine C chez les patients atteints d'un cancer étaient diminués en comparaison avec ceux de personnes non atteintes d'un cancer, et que ces niveaux étaient variables selon la sévérité et le stade de la maladie. Ces résultats ont mené à formuler l'hypothèse que l'administration intraveineuse de la vitamine C à haute dose pourrait rétablir ou surélever les niveaux plasmatiques de celle-ci chez les patients atteints d'un cancer, et avoir un effet bénéfique sur leur survie et leur qualité de vie. Depuis, de nombreuses études cliniques et précliniques en laboratoire (modèles cellulaires et animaux) ont évalué si la vitamine C à des concentrations très élevées pouvait, par l'action de différents mécanismes cellulaires, exercer une activité anticancéreuse ou encore accroitre l'efficacité des traitements antinéoplasiques. CONTEXTE: Soutenues par une plausibilité biologique apparente et des demandes de la part des patients, des proches aidants et des praticiens, deux pétition


INTRODUCTION: Observational studies in the late 1970s reported increased overall survival and quality of life in patients with various types of terminal cancer treated with high-dose vitamin C injections. Other publications reported that plasma levels of vitamin C in cancer patients were decreased compared to those of non-cancer patients, and that these levels would vary depending on the severity and stage of the disease. These results led to the hypothesis that high-dose intravenous administration of vitamin C could restore or elevate plasma levels of vitamin C in cancer patients and have a beneficial effect on their survival and quality of life. Since then, many clinical and preclinical laboratory studies (cellular and animal models) evaluated whether vitamin C at very high concentrations could, through the action of different cellular mechanisms, exert anticancer activity or increase the effectiveness of antineoplastic treatments. CONTEXT: Supported by apparent biological plausibility and requests from patients, caregivers, and practitioners, two petitions were submitted to the Québec National As


Asunto(s)
Humanos , Ácido Ascórbico/uso terapéutico , Administración Intravenosa/instrumentación , Neoplasias/tratamiento farmacológico , Evaluación en Salud/economía , Eficacia
3.
Anesth Analg ; 134(1): 59-68, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34517393

RESUMEN

BACKGROUND: Medication dosing errors can occur during microinfusions when there is vertical pump displacement or multidrug infusion through a single intravenous path. We compared flow rate variability between new-generation cylinder-type infusion pumps and conventional infusion pumps under simulated conditions. METHODS: We evaluated the flow rates during microinfusions using different infusion pumps (syringe pump with 10/30/50-mL syringes, peristaltic pump, and cylinder pump). Two visible dyes were used as model drugs. The study samples were quantified using spectrophotometry. For vertical displacement, the infusion pumps were moved up and down by 60 cm during microinfusions at 0.5 mL·h-1 and 2 mL·h-1. In the multi-infusion study, the second drug flow was added through 4 linearly connected stopcocks either upstream or downstream of the first drug. We compared the total error dose between the cylinder pump and the syringe pump with a Mann-Whitney U test and additionally estimated the effects of the infusion pumps on total error doses by linear regression analysis. RESULTS: There were repetitive patterns of temporary flow increases when the pump was displaced upward and flow decreases when the pump was displaced downward in all settings. However, the amount of flow irregularities was more pronounced at the lower infusion rate and in the syringe-type pump using larger volume syringes. The total error dose increased in the syringe pump loaded with a 50-mL syringe compared to that of the new cylinder pump (regression coefficient [ß] = 4.66 [95% confidence interval {CI}, 1.60-7.72]; P = .008). The initiation and cessation of a new drug during multidrug microinfusion in the same intravenous path affected the lower rate first drug leading to a transient flow rate increase and decrease, respectively. The change in flow rate was observed regardless of the port selected for addition of the second drug, and the total error dose of the first drug did not significantly vary when an upstream or a downstream port was selected. CONCLUSIONS: In the microinfusion settings, attention must be paid to the use of the syringe pump loaded with large-volume syringes. The novel cylinder pump could be considered as a practical alternative to syringe pumps with small syringes given its flow stability without the need for frequent drug replacement.


Asunto(s)
Administración Intravenosa/instrumentación , Administración Intravenosa/métodos , Bombas de Infusión , Errores de Medicación/prevención & control , Jeringas , Simulación por Computador , Diseño de Equipo , Humanos , Modelos Lineales , Análisis de Regresión , Reproducibilidad de los Resultados , Estadísticas no Paramétricas
4.
Braz. J. Pharm. Sci. (Online) ; 58: e191124, 2022. tab
Artículo en Inglés | LILACS | ID: biblio-1394054

RESUMEN

Abstract Snakebite is one of the major health issues posing considerable morbidity and mortality. According to an estimate of World Health Organization (WHO) (World health organization, 2021) approximately 5 million people are bitten by several species of snakes resulting in up to 2.5 million envenomation cases annually. The mainstay of treatment for envenomation is intravenous administration of anti-snake venom. Although antivenom neutralizes the systemic effects but it does not relieve the symptoms such as venom-induced hemorrhage, necrosis and nephrotoxicity. Moreover, the use of antivenoms is associated with hypersensitivity reactions including urticaria, anaphylaxis, or serum sickness due to their heterologous property. Furthermore, stringent storage conditions and narrow specificity of antivenoms limit their use in both developed as well as developing countries. In this context, researchers have been searching for natural products and plant extracts to explore their antivenom activity along with anti-myotoxic, anti-hemorrhagic and anti-inflammatory properties. Plant remedies may prove to be an effective alternate for antivenom sera with less adverse events and better tolerability. To the best of our knowledge, this is the first comprehensive review of medicinal plants possessing anti-snake venom activities against certain species of snakes. The current review highlights the investigated plants with their phytochemical analysis to integrate the available information for future research and development of antivenom sera.


Asunto(s)
Plantas Medicinales/efectos adversos , Venenos de Serpiente/análisis , Antivenenos/análisis , Venenos Elapídicos/aislamiento & purificación , Fitoquímicos/agonistas , Mordeduras de Serpientes/clasificación , Organización Mundial de la Salud , Extractos Vegetales , Administración Intravenosa/instrumentación
5.
Am J Nurs ; 121(8): 46-50, 2021 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-34819473

RESUMEN

ABSTRACT: Secondary infusion by large-volume IV smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an IV smart pump.


Asunto(s)
Administración Intravenosa/instrumentación , Administración Intravenosa/métodos , Bombas de Infusión , Seguridad de Equipos/métodos , Seguridad de Equipos/enfermería , Seguridad de Equipos/normas , Humanos
6.
Pediatrics ; 147(2)2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33446506

RESUMEN

OBJECTIVES: In children, intravenous therapy (IVT) is generally administered via peripheral intravenous catheters (PIVCs) (2-6 cm in length). There is evidence that PIVCs are unreliable after 2 days. Long peripheral catheters (LPCs) (6-15 cm in length) could improve the delivery of IVT. The aim of this trial was to determine if LPCs could decrease catheter failure and the number of catheters in children receiving multiday IVT. METHODS: This was an open-label randomized controlled trial conducted at Monash Children's Hospital in Melbourne, Australia. Participants were from the ages of 1 to 17 years, undergoing surgery and requiring >48 hours of postoperative IVT. Participants were randomly assigned to a 2.5-cm 22G PIVC or an 8-cm 22G LPC. RESULTS: Seventy-two children were randomly assigned, 36 received PIVCs, and 36 received LPCs. The median duration of IVT was 5.1 days and was similar between groups (P = .9). Catheter failure was higher for PIVCs than LPCs (66.7% vs 19.4%; relative risk [RR]: 3.4; P = .0001 or 187.9 vs 41.0 failures per 1000 catheter-days). Infiltration was the most common reason for PIVC failure (33.3% vs 2.8%; RR: 12.0; P = .001). LPCs exhibited superior life span (4.7 vs 3.5 days [median]; P = .01). Children with LPCs were twice as likely to complete therapy with a single catheter (80.6% vs 38.9%; RR: 2.1; P = .0006). CONCLUSIONS: LPCs reduce catheter failure and total catheters in children. They should be considered as the first-line device for peripheral access in any child receiving prolonged IVT.


Asunto(s)
Administración Intravenosa/instrumentación , Administración Intravenosa/normas , Cateterismo Periférico/instrumentación , Cateterismo Periférico/normas , Catéteres de Permanencia/normas , Administración Intravenosa/economía , Adolescente , Cateterismo Periférico/economía , Catéteres/economía , Catéteres/normas , Catéteres de Permanencia/economía , Niño , Preescolar , Remoción de Dispositivos/economía , Remoción de Dispositivos/normas , Esquema de Medicación , Femenino , Humanos , Lactante , Masculino
7.
Braz. J. Pharm. Sci. (Online) ; 57: e18910, 2021. tab, graf
Artículo en Inglés | LILACS | ID: biblio-1345454

RESUMEN

Chemotherapy induced nausea and vomiting (CINV) is an issue, which usually occurs in cancer patient. Despite high bioavailability of oral and intravenous administration, these have some drawbacks. The oral route causes hepatic first pass metabolism and intravenous route is invasive in nature. Hence, antiemetic drug by means of transdermal route is necessary to administer in such cases. The aim of the present investigation is to develop suitable Transdermal Therapeutic System (TTS) with an objective to enhance solubility and skin permeability properties of metoclopramide base. Preformulation study begins with an approach to enhance solubility of 40 metoclopramide base by solid dispersion technique. transdermal films were prepared with 41 the solid dispersion as well as with pure drug. Phase solubility study at various temperatures reveals binding constants (Ka, 95-350 M-1 for PVP K30; 56-81 M-1 for HPßCD). Spontaneity of solubilization was justified by AL type linear profiles. The films showed satisfactory diffusion (%), permeation rate and flux after 8 h study. The transdermal patches as prepared were analyzed under FTIR, DSC and SEM. Both solubility and permeability rate in this investigation have been enhanced. So, it can be affirmed that this route would effectively enhance bioavailability


Asunto(s)
Solubilidad , Metoclopramida/antagonistas & inhibidores , Pacientes/clasificación , Preparaciones Farmacéuticas/administración & dosificación , Disponibilidad Biológica , Espectroscopía Infrarroja por Transformada de Fourier , Difusión/efectos de los fármacos , Quimioterapia , Administración Intravenosa/instrumentación , Películas Cinematográficas , Neoplasias/patología
8.
J Infect Dis ; 222(Suppl 5): S494-S498, 2020 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-32877541

RESUMEN

BACKGROUND: Research is limited on combining outpatient parenteral antimicrobial therapy (OPAT) with addiction treatment for people who inject drugs (PWID) with serious infections. METHODS: This is a retrospective study of PWID (n = 68) requiring intravenous antibiotics evaluated for suitability for our OPAT program with concurrent addiction treatment. RESULTS: Most common infections were bacteremia and/or endocarditis (73.5%), bone and/or joint infections (32.4%), and epidural abscess (22.1%). Of the 20 patients (29.4%) who qualified, 100.0% completed the course of antibiotics, 30.0% experienced a 30-day readmission, and 15.0% relapsed. No overdoses, deaths, or peripherally inserted central catheter-line complications were reported. CONCLUSIONS: Outpatient parenteral antimicrobial therapy with addiction treatment may be feasible and safe for PWID with serious infections.


Asunto(s)
Atención Ambulatoria/métodos , Antibacterianos/administración & dosificación , Bacteriemia/tratamiento farmacológico , Enfermedades Óseas Infecciosas/tratamiento farmacológico , Endocarditis Bacteriana/tratamiento farmacológico , Abuso de Sustancias por Vía Intravenosa/terapia , Administración Intravenosa/efectos adversos , Administración Intravenosa/instrumentación , Adulto , Atención Ambulatoria/estadística & datos numéricos , Antibacterianos/efectos adversos , Bacteriemia/microbiología , Enfermedades Óseas Infecciosas/microbiología , Catéteres Venosos Centrales/efectos adversos , Endocarditis Bacteriana/microbiología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Readmisión del Paciente/estadística & datos numéricos , Estudios Retrospectivos , Abuso de Sustancias por Vía Intravenosa/complicaciones , Resultado del Tratamiento
9.
Mil Med ; 185(Suppl 1): 121-129, 2020 01 07.
Artículo en Inglés | MEDLINE | ID: mdl-32074308

RESUMEN

INTRODUCTION: Exsanguination remains the leading cause of preventable death in military conflicts, and pediatric casualties are common. Transfusion is crucial to preserve life, but vascular access is challenging in children, so intraosseous (IO) access is often required. However, the optimal transfusion method is unclear. There was therefore the need for feasibility testing of a model for contrasting the efficacy of blood infusion devices via intravenous (IV) and IO access in immature swine with bone densities similar to children. MATERIALS AND METHODS: Eighteen immature swine (21 ± 1 kg) were bled 31% of estimated blood volume and then received autologous blood delivered by pressure bag, push-pull (PP), or LifeFlow Rapid Infuser via IO (15-gauge IO needle placed in the humeral head) or IV (auricular 20-gauge), with monitoring for 60 minutes. RESULTS: Flow rates for LifeFlow (172 ± 28 mL/kg) were 4-fold higher than pressure bag (44 ± 13 mL/kg, P < 0.001) and 80% higher than PP (95 ± 28 mL/kg, P < 0.02). However, higher hemolysis was evident in the IV LifeFlow condition, with 6-fold more plasma-free hemoglobin than other conditions (P < 0.0001). CONCLUSIONS: IV LifeFlow conferred higher flows, but higher hemolysis in this pilot study demonstrates the feasibility of an immature swine model toward determining optimal methods for resuscitating children with hemorrhagic shock.


Asunto(s)
Transfusión Sanguínea/métodos , Choque Hemorrágico/prevención & control , Administración Intravenosa/instrumentación , Administración Intravenosa/métodos , Análisis de Varianza , Animales , Transfusión Sanguínea/instrumentación , Transfusión Sanguínea/estadística & datos numéricos , Modelos Animales de Enfermedad , Infusiones Intraóseas/instrumentación , Infusiones Intraóseas/métodos , Proyectos Piloto , Choque Hemorrágico/tratamiento farmacológico , Choque Hemorrágico/fisiopatología , Porcinos/sangre , Porcinos/lesiones
10.
Trials ; 21(1): 78, 2020 Jan 14.
Artículo en Inglés | MEDLINE | ID: mdl-31937342

RESUMEN

BACKGROUND: The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter). METHODS/DESIGN: A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day. DISCUSSION: The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses' adoption of good clinical practices in intravenous procedures, reducing catheter manipulations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04046770. Registered 13 August 2019.


Asunto(s)
Administración Intravenosa/instrumentación , Infecciones Relacionadas con Catéteres/prevención & control , Catéteres de Permanencia/efectos adversos , Jeringas/efectos adversos , Adulto , Diseño de Equipo , Femenino , Humanos , Inyecciones Intravenosas/métodos , Masculino , Flebitis/epidemiología , Proyectos de Investigación , Seguridad , Jeringas/tendencias , Resultado del Tratamiento
11.
Artículo en Inglés | MEDLINE | ID: mdl-33561056

RESUMEN

A new double-chamber syringe (DUO Syringe) was developed for intravenous drug administration and catheter flushing. This study presents a protocol for pre-clinical usability tests to validate the golden prototype of this new device, performed in a high-fidelity simulation lab by nurses. A two-steps parallel randomized controlled trial with two arms was designed (with standard syringes currently used in clinical practice and with the DUO Syringe). After randomization, eligible and consented participants will be requested to perform, individually, intravenous drug administration and flushing, following the arm that has been allocated. The procedure will be video-recorded for posterior analyses. After the completion of the tasks, nurses will be asked to answer a demographic survey, as well as an interview about their qualitative assessment of the device. A final focus group with all participants will also be conducted. Primary outcomes will concern the DUO Syringe's effectiveness, efficiency, and safety, while secondary outcomes will focus on nurses' satisfaction and intention of use. The pre-clinical protocol was defined according to the legal requirements and ISO norms and was reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing of the Nursing School of Coimbra.


Asunto(s)
Administración Intravenosa/instrumentación , Preparaciones Farmacéuticas/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Jeringas/efectos adversos , Diseño de Equipo , Humanos , Resultado del Tratamiento
12.
J Vasc Access ; 21(6): 805-809, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31804149

RESUMEN

Epicutaneo-caval catheters have been widely used in neonatal intensive care units since Shaw has described them in 1973. These central venous access devices are usually placed at bedside and they have the purpose of delivering parenteral nutrition and/or drugs that are not compatible with the peripheral route. Even though in the last decade there was a fast advancement in the world of vascular access devices, such changes have only marginally affected the field of neonatal venous access. The aim of this editorial is to give 10 recommendations that correspond to 10 novelties in the field of epicutaneo-caval catheter: some are already evidence-based and should be introduced in our daily practice now, while others are particularly interesting and deserve further clinical studies.


Asunto(s)
Cateterismo Venoso Central/instrumentación , Cateterismo Periférico/instrumentación , Catéteres de Permanencia , Catéteres Venosos Centrales , Cuidado Intensivo Neonatal , Administración Intravenosa/instrumentación , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Diseño de Equipo , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Nutrición Parenteral/instrumentación , Preparaciones Farmacéuticas/administración & dosificación , Factores de Riesgo , Resultado del Tratamiento
13.
Nucl Med Commun ; 41(1): 11-17, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31764593

RESUMEN

OBJECTIVE: Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [Tc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [Ga]Ga-DOTA-TOC (Somakit-TOC). METHODS: Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (<25 ml). Sorption tests were performed according to the literature. RESULTS: After 2 h storage in a syringe, drug sorption of Tektrotyd and Somakit-TOC was of less than 2.5% and similar to other Tc-radiopharmaceuticals (range: from 1.1 ± 0.5% to 4.2 ± 0.6%). For Tektrotyd, this sorption phenomenon was positively influenced by the drug concentration and a short contact with the medical device (4.8 ± 0.2% up to 5 s vs. 2.3 ± 0.2%, n = 4; P < 0.001). For Somakit-TOC, the duration of contact with syringe had no impact (1.6 ± 0.2% up to 5 s vs. 1.7 ± 0.6%; P = 1.000). No drug radiolysis or alteration of microbiological aspects were observed. No impurity from a 3-piece-syringe was observed according to drug aspect, pH, and subvisible and visible particles, which remained within specification of the current European Pharmacopoeia. CONCLUSION: This study found that drug sorption to packaging was compatible with clinical use and absence of drug alteration of Tektrotyd and Somakit-TOC after repackaging in a syringe in polypropylene and prolonged storage during 2 h.


Asunto(s)
Administración Intravenosa/instrumentación , Ácido Edético/análogos & derivados , Octreótido/análogos & derivados , Compuestos Organometálicos/administración & dosificación , Compuestos de Organotecnecio/administración & dosificación , Compuestos de Organotecnecio/química , Contaminación de Medicamentos , Ácido Edético/administración & dosificación , Ácido Edético/química , Ácidos Nicotínicos/química , Octreótido/administración & dosificación , Control de Calidad , Jeringas/microbiología
14.
Nurs Child Young People ; 31(3): 38-46, 2019 May 09.
Artículo en Inglés | MEDLINE | ID: mdl-31468865

RESUMEN

Research and advances in technology have enabled children and young people with life-limiting conditions to live longer. To maintain their well-being and quality of life many of these children usually require some form of intravenous access for treatment. Children's nurses should have the skills and training to ensure they are competent to practise using totally implanted central venous access devices such as portacaths (ports). This article addresses the care and management of these ports in children and the wide variation in practice that exists in the UK, and makes recommendations for practice.


Asunto(s)
Dispositivos de Acceso Vascular/tendencias , Administración Intravenosa/instrumentación , Adolescente , Niño , Niños con Discapacidad/rehabilitación , Niños con Discapacidad/estadística & datos numéricos , Diseño de Equipo/normas , Humanos , Calidad de Vida/psicología , Reino Unido , Dispositivos de Acceso Vascular/efectos adversos
15.
Ann Oncol ; 30(8): 1329-1334, 2019 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-31132094

RESUMEN

BACKGROUND: The prognosis of Hodgkin lymphoma (HL) is excellent rendering research into treatment complications highly important. An important complication of cancer and its treatment is thrombosis. Thrombotic events are regularly observed in HL patients but precise information on incidence and risk factors is lacking and the value of prophylactic anticoagulation unclear. PATIENTS AND METHODS: Thus, we comprehensively studied thrombotic events in 5773 patients from the German Hodgkin Study Group (GHSG) HD13-15 trials in early-favorable, intermediate and advanced HL. We estimated the incidence of and identified risk factors for thrombotic events. Additionally, we provide detailed data on the time course and characteristics of thrombotic events. RESULTS: A total of 193 thrombotic events occurred for an incidence of 3.3%. Out of these, 175 (90.7%) were venous thromboses, 3 (1.5%) newly emerging post-thrombotic syndromes and 15 (7.8%) arterial thromboses. There were 11 (0.7%) events in early-favorable, 27 (1.3%) in early-unfavorable and 155 (7.3%) in advanced patients, the latter incidence being significantly higher (P < 0.001). The most common locations were deep vein thrombosis of the arm (46.3%) and leg (24.6%). Most venous thrombotic events occurred during chemotherapy (78.9%). We observed 59 (30.6%) catheter-associated events and a descriptively increased risk of venous thrombotic events in patients with oral contraception use during treatment (6.8% versus 3.9%). In advanced HL, the incidence of venous thrombotic events was increased upon treatment with BEACOPP-14 (9.4%, P = 0.0079) compared with 5.1% with 6×BEACOPPesc and 5.7% with 8×BEACOPPesc. Among commonly applied risk factors, including the Khorana score, only age and smoking were prognostic. CONCLUSIONS: The incidence of thrombotic events in advanced stage HL is comparable to other high-risk cancer patients, especially if treated with dose-dense regimens. Additional risk factors are higher age and smoking. Selected HL patients could benefit from prophylactic anticoagulation, however, further interventional studies are needed before general recommendations can be made.


Asunto(s)
Anticoagulantes/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Enfermedad de Hodgkin/tratamiento farmacológico , Trombosis/epidemiología , Administración Intravenosa/efectos adversos , Administración Intravenosa/instrumentación , Administración Oral , Adolescente , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Catéteres/efectos adversos , Anticonceptivos Orales/efectos adversos , Femenino , Alemania/epidemiología , Enfermedad de Hodgkin/patología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Trombosis/inducido químicamente , Trombosis/prevención & control , Adulto Joven
16.
Ann Emerg Med ; 74(1): 19-27, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31126618

RESUMEN

STUDY OBJECTIVE: We determine whether ultrasonographically guided intravenous line placement improves the rate of first-attempt success by 20% for children with predicted difficult intravenous access. Secondary objectives included determining whether ultrasonographically guided intravenous line placement reduces the attempt number, improves time to access or parental satisfaction, or affects intravenous line survival and complications. METHODS: This was a prospective, randomized controlled trial conducted in an urban tertiary care pediatric emergency department that enrolled a convenience sample of children requiring an intravenous line and who were predicted to have difficult intravenous access according to a previously validated score. Participants were randomized to traditional or ultrasonographically guided intravenous line placement on first attempt and stratified by aged 0 to 3 versus older than 3 years. RESULTS: One hundred sixty-seven patients were enrolled and randomized to traditional intravenous line or to a care bundle with a multidisciplinary team trained to place ultrasonographically guided intravenous lines. First-attempt success was increased in the ultrasonographically guided intravenous line placement arm (n=83) compared with the traditional intravenous line arm (n=84) (85.4% versus 45.8%; relative risk 1.9; 95% confidence interval [CI] 1.5 to 2.4). There were fewer attempts in the ultrasonographically guided intravenous line placement arm than in the traditional intravenous line arm (median 1 versus 2; median difference 1; 95% CI 0.8 to 1.2) and a shorter time from randomization to intravenous line flush (median 14 minutes [interquartile range 11 to 20] versus 28 minutes [interquartile range 16 to 42]). A Kaplan-Meier survival analysis demonstrated that ultrasonographically guided intravenous lines survived longer than traditional ones (median 7.3 days [95% CI 3.7 to 9.5] versus 2.3 days [95% CI 1.8 to 3.3]). There was no difference in complications between the groups. Parents were more satisfied with ultrasonographically guided intravenous line placement. CONCLUSION: Ultrasonographically guided intravenous line placement in children with predicted difficult intravenous access improved first-attempt success and intravenous line longevity when conducted by a team of trained providers.


Asunto(s)
Administración Intravenosa/instrumentación , Cateterismo Periférico/métodos , Medicina de Urgencia Pediátrica/métodos , Ultrasonografía Intervencional/métodos , Administración Intravenosa/efectos adversos , Administración Intravenosa/métodos , Adolescente , Cateterismo Periférico/efectos adversos , Catéteres de Permanencia/efectos adversos , Niño , Preescolar , Servicio de Urgencia en Hospital , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Paquetes de Atención al Paciente/métodos , Satisfacción Personal , Estudios Prospectivos
17.
Pediatr Nephrol ; 34(8): 1413-1424, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31028470

RESUMEN

BACKGROUND: Phthalates are associated with increased blood pressure in children. Large exposures to di-(2-ethylhexyl) phthalate (DEHP) among premature infants have been a cause for concern. METHODS: We conducted a prospective observational cohort study to determine if DEHP exposures are related to systolic blood pressure (SBP) in premature infants, and if this exposure is associated with activation of the mineralocorticoid receptor (MR). Infants were monitored longitudinally for 8 months from birth. Those who developed idiopathic hypertension were compared with normotensive infants for DEHP exposures. Appearance of urinary metabolites after exposure was documented. Linear regression evaluated the relationship between DEHP exposures and SBP index and whether urinary cortisol/cortisone ratio (a surrogate marker for 11ß-HSD2 activity) mediated those relationships. Urinary exosomes were quantified for sodium transporter/channel expression and interrogated against SBP index. RESULTS: Eighteen patients met the study criteria, nine developed transient idiopathic hypertension at a postmenstrual age of 40.6 ± 3.4 weeks. The presence of urinary DEHP metabolites was associated with prior IV and respiratory tubing DEHP exposures (p < 0.05). Both IV and respiratory DEHP exposures were greater in hypertensive infants (p < 0.05). SBP index was related to DEHP exposure from IV fluid (p = 0.018), but not respiratory DEHP. Urinary cortisol/cortisone ratio was related to IV DEHP and SBP index (p < 0.05). Sodium transporter/channel expression was also related to SBP index (p < 0.05). CONCLUSIONS: Increased blood pressure and hypertension in premature infants are associated with postnatal DEHP exposure. The mechanism of action appears to be activation of the MR through inhibition of 11ß-HSD2.


Asunto(s)
Dietilhexil Ftalato/toxicidad , Hipertensión/epidemiología , Enfermedades del Prematuro/epidemiología , Plastificantes/toxicidad , 11-beta-Hidroxiesteroide Deshidrogenasas/metabolismo , Administración Intravenosa/efectos adversos , Administración Intravenosa/instrumentación , Manejo de la Vía Aérea/efectos adversos , Manejo de la Vía Aérea/instrumentación , Presión Sanguínea/efectos de los fármacos , Femenino , Humanos , Hipertensión/inducido químicamente , Hipertensión/diagnóstico , Hipertensión/metabolismo , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/inducido químicamente , Enfermedades del Prematuro/diagnóstico , Masculino , Estudios Prospectivos , Receptores de Mineralocorticoides/metabolismo , Transducción de Señal/efectos de los fármacos
18.
Am J Drug Alcohol Abuse ; 45(4): 377-384, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30990363

RESUMEN

Background: Extended-release (ER) morphine formulations are commonly manipulated for non-oral routes of administration, particularly via injection. Morphine ARER, an abuse-deterrent formulation of ER morphine, has both physical and chemical properties that deter abuse. Objectives: To assess the syringeability of morphine ARER using in vitro laboratory studies. Methods: Intact, cut, or crushed morphine ARER tablets were incubated in 1, 5, or 10 mL of room temperature or 90°C water for 1, 5, 10, or 30 min of agitation. Crushed ER morphine tablets were assessed in 10 mL room temperature water. The difficulty to draw the mixture into a syringe was assessed on a scale of 1 (very easy) to 10 (impossible). If the prepared mixture was syringeable, released morphine was measured analytically. Results: Crushed and cut morphine ARER tablets formed a viscous material when subjected to a liquid environment and were rated as "impossible to syringe" in ≤5 mL water and were slightly syringeable in 10 mL water. In contrast, all syringeability tests of crushed ER morphine were rated as "very easy to syringe". After 30 min in room temperature water, crushed ER morphine released 75% morphine whereas intact, cut, and crushed morphine ARER tablets released a maximum of 12%, 12%, and 5% of the total morphine content. Heating extractions resulted in increased morphine release. Conclusion: The difficulty to syringe morphine ARER when manipulated suggests that morphine ARER has abuse-deterrent properties that may deter intravenous abuse.


Asunto(s)
Formulaciones Disuasorias del Abuso , Preparaciones de Acción Retardada/química , Morfina/química , Jeringas , Viscosidad , Administración Intravenosa/instrumentación , Comprimidos
19.
J Emerg Med ; 57(1): 1-5, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31031072

RESUMEN

BACKGROUND: When intravenous access cannot be established using traditional methods of inspection/palpation, advanced methods are often required, leading to substantial delays in care. Knowing the likelihood of intravenous access failure can improve emergency department (ED) efficiency. OBJECTIVE: Our aim was to validate prior need for an advanced technique to establish intravenous access as a predictor of failure to achieve access via traditional methods and to estimate the risk difference associated with this finding. METHODS: We re-analyzed data collected for a clinical trial that randomized ED patients requiring intravenous access to one of two types of intravenous catheter; gauge size was selected by the inserter. The re-analysis pools data from both groups to examine predictors of failure to establish intravenous access by traditional methods, with failure defined as abandonment or use of an advanced technique (ultrasound guidance or external jugular vein catheterization). Confidence intervals for the difference between proportions were calculated using a normal binomial approximation. RESULTS: We obtained data from 600 patients, with a median age of 52 years (interquartile range 36-63 years). We noted failure of traditional methods in 28 (4.7%) patients, including 17 of 109 (16%) with prior need for advanced techniques. The risk difference for prior need for advanced techniques versus no prior difficulty was 14% (95% confidence interval 7-22). CONCLUSIONS: Patients with a prior need for advanced techniques were 14% more likely to have failure of intravenous access by traditional methods than those without prior difficulty.


Asunto(s)
Administración Intravenosa/instrumentación , Análisis de Falla de Equipo , Administración Intravenosa/efectos adversos , Adulto , Cateterismo Venoso Central/instrumentación , Cateterismo Venoso Central/métodos , Cateterismo Venoso Central/normas , Cateterismo Periférico/instrumentación , Cateterismo Periférico/métodos , Cateterismo Periférico/normas , Servicio de Urgencia en Hospital/organización & administración , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Estudios Prospectivos
20.
Med Sci Monit ; 25: 2016-2023, 2019 Mar 18.
Artículo en Inglés | MEDLINE | ID: mdl-30880792

RESUMEN

BACKGROUND The purpose of this study was to develop a remote-controlled injection device for T-tube cholangiography to avoid occupational exposure. MATERIAL AND METHODS The remote-controlled injection device has 3 major components: an injection pump, a pressure sensor, and a wireless remote-control panel. The feasibility and effectiveness of this device for T-tube cholangiography was evaluated in ex vivo porcine livers using a laparoscopic training platform and in in vivo canine experiments. RESULTS The contrast dye was successfully injected into the biliary tracts of the ex vivo porcine liver and canines by the designed device. The X-ray images clearly showed the anatomical structure of the bile ducts. No obvious adverse reaction was observed in the dogs during or after the procedure. All steps were controlled remotely, avoiding ionizing radiation exposure to the surgeons. CONCLUSIONS This novel remote-controlled injection device for T-tube cholangiography can assist operators in completing cholangiography remotely and protecting them from occupational exposure.


Asunto(s)
Administración Intravenosa/instrumentación , Colangiografía/métodos , Medios de Contraste/administración & dosificación , Administración Intravenosa/métodos , Animales , Conductos Biliares/diagnóstico por imagen , Colangiografía/instrumentación , Perros , Estudios de Factibilidad , Hígado/diagnóstico por imagen , Masculino , Complicaciones Posoperatorias , Porcinos
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