MASCC 2023 Patient-Centered Antiemetic Guidelines and Education Statements: an evidence-based and consensus resource for patients.

PURPOSE: The Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Patient Antiemetic Guideline Committee aimed to (1) adapt the updated evidence-based, clinical guidelines to patient-centered antiemetic guidelines and (2) develop patient education materials and statements. METHODS: The MASCC 2023 Patient Antiemetic Guidelines were created and reviewed by antiemetic experts and patient advocates by incorporating the 2023 MASCC/ESMO antiemetic guidelines into patient-friendly language. Patient Education Statements were developed based on current literature and by utilizing an expert modified Delphi consensus (≥ 75% agreement). Patient advocate/focus group input and patient survey results were further integrated into Patient-Centered Antiemetic Guidelines and Education Statements. RESULTS: Patient-Centered Antiemetic Guidelines were created using patient-friendly language and visual slides. Patient-friendly language was also utilized to communicate the Educational Statements. Key content categories identified for the Educational Statements included the following: nausea/vomiting definitions, causes, risk factors, categories, complications, accompanying symptoms, prophylactic antiemetic treatment, general management, when to call/what to ask the healthcare team, what caregivers can do, and available resources. All identified content met the ≥ 75% expert agreement threshold. Fifteen (15) items demonstrated 100% agreement, 11 items achieved ≥ 90% agreement, and three content items demonstrated 80 ~ 82% agreement. CONCLUSIONS: The inaugural MASCC 2023 Patient Antiemetic Guidelines can help patients and caregivers understand the prevention of nausea and vomiting related to their cancer treatment. Educational Statements provide further patient information. Educating patients on how to utilize guideline antiemetics and the education statements can contribute improvements in the control of anticancer treatment-related nausea and vomiting.

A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy.

OBJECTIVE: The aim of this study is to assess the clinical efficacy of a 5 mg dosage of olanzapine in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) among female patients diagnosed with gastrointestinal tract tumors. METHODS: Patients undergoing the oxaliplatin/irinotecan chemotherapy regimen were enrolled in this prospective controlled study. The olanzapine group received a 5 mg dosage of olanzapine along with palonosetron and dexamethasone, while the control group received a standard two-combination regimen consisting of dexamethasone and palonosetron. The primary endpoints included the total protection (TP) rates for the entire age group and the subgroup aged 60 years and above. Secondary endpoints encompassed the total protection rates during the acute and delayed phases within the two age brackets, as well as the total control (TC) rates and complete remission (CR) rates across all three phases (total, acute, and delayed). Additionally, the study involved the assessment of quality of life and the collection of adverse events associated with the interventions. RESULTS: 1) Regarding the primary endpoint, the total phase TP rates within both the entire age group and the age group exceeding 60 years demonstrated superiority in the olanzapine group when compared to the control group (66.7% vs 37.25%, P = 0.003; 68.8% vs 44.4%, P = 0.044). 2) In terms of secondary endpoints, the olanzapine group exhibited superior acute phase TP rates in both age brackets when compared to the control group (P < 0.05). The olanzapine group also demonstrated higher delayed-phase TP rates, TC rates across all three phases, and CR rates within the two age brackets, although the differences were not statistically significant (P > 0.05). Furthermore, the quality of life in the olanzapine group surpassed that of the control group for both age brackets (P < 0.05), characterized by enhanced appetite and a higher incidence of drowsiness in the patients treated with olanzapine when compared to those in the control group (P < 0.05). CONCLUSION: Olanzapine can enhance CINV induced by MEC regimen in female patients across all age groups, including the elderly, and therefore improve the quality of life for these patients. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/index.html , identifier: ChiCTR20000368269, 25/08/2020.

Efficacy and safety of netupitant/palonosetron in preventing nausea and vomiting in diffuse large B cell lymphoma patients undergoing R-CHOP chemotherapy.

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma, for which cyclophosphamide, doxorubicin, vincristine, and prednisone with rituximab(R-CHOP) is one of the standard regimens. Given that R-CHOP is highly emetogenic, chemotherapy-induced nausea and vomiting (CINV) prevention is clinically important. However, there is a paucity of studies focusing on these patients. This study aimed to ascertain the effectiveness of an oral fixed-dose combination of netupitant and palonosetron (NEPA) in preventing CINV in patients with DLBCL undergoing first-line R-CHOP chemotherapy. Seventy patients were enrolled in this single-center prospective non-comparative study conducted between November 2020 and May 2023 in South Korea. NEPA was administered 1 h prior to chemotherapy initiation on day 1. The primary endpoint of the study was the complete response rate (no emesis, and no rescue medication) during the acute, delayed, and overall phases, which were assessed over a period of 120 h post-chemotherapy. The complete response rates for NEPA were 90.0% [95% CI 80.5, 95.9] for the acute phase, 85.7% [95% CI 75.3, 92.9] for the delayed phase, and 84.3% [95% CI 73.6, 91.9] for the overall phase, with no-emesis rates (acute: 97.1% [95% CI 97.1, 99.7], delayed: 95.7% [95% CI 88.0, 99.1], overall: 92.9% [95% CI 84.1, 97.6]). NEPA was well tolerated with no severe treatment-emergent adverse events. NEPA exhibited substantial efficacy in mitigating CINV in DLBCL patients undergoing R-CHOP chemotherapy, demonstrating high CR and no-emesis rates, and favorable safety profiles.

The prophylactic antiemetic therapies in management of differentiated thyroid cancer patients with radioactive iodine therapy: a single-center, non-randomized clinical trial.

Objective: The present study was to investigate three different single-drug regimens to show which was more effective to reduce radioactive iodine therapy (RAI) associated nausea and vomiting, and to compare the occurrence of long-term gastrointestinal diseases after RAI therapy. Method: We performed a single-center, non-randomized clinical trial among patients who underwent RAI therapy from March 2016 to July 2022. Enrolled patients were divided into four cohorts based on the date of the treatment. cohort 1, with no preventive antiemetics; cohort 2, received 20 mg of pantoprazole per day for 3 days; cohort 3, received a 10 mg metoclopramide tablet two times daily for 3 days; cohort 4, oral ondansetron, 8 mg, twice daily for 3 days. The primary endpoints were proportion of patients who experience vomiting episodes and nausea during the 7-day hospital period. Secondary end points included Functional Living Index Emesis (FLIE) quality-of life questionnaires and the occurrence of gastrointestinal diseases. Results: A total of 1755 patients were analyzed, comprised of 1299 (74.0%) women and 456 (26.0%) men, with a median age of 44 years (range 18-78 years). The characteristics of patient were similar within the four groups. 465 (26.4%) patients developed RAI-associated nausea, and 186 (14.4%) patients developed RAI-associated vomiting. The rate of nausea was significantly decreased in the patients who were taking ondansetron when compared with the other cohorts (P<0.05), while the rate of vomiting (≥6 episodes) was slightly lower. As secondary endpoint, FLIE measures ondansetron scored highly compared to other cohorts, from baseline (mean score of 110.53 ± 17.54) to day 7 (mean score of 105.56 ± 12.48). In addition, 48 (2.7%) patients were found to be with gastrointestinal diseases at the end of one year follow up. Multiple RAI therapy and higher dose of I-131 per body weight revealed a significantly independent risk factors of developing gastrointestinal disorders. Conclusions: In conclusion, the present study demonstrated that short-term ondansetron could be an effective prophylactic agent in controlling RAI-associated nausea and vomiting. Furthermore, the risk of developing gastrointestinal disorders was significantly higher for patients with multiple RAI therapy and higher dose of I-131 per body weight.

Commonly used antiemetics for prophylaxis of postoperative nausea and vomiting after Caesarean delivery with neuraxial morphine: a network meta-analysis.

BACKGROUND: Dopamine antagonists, 5-HT3 antagonists, and dexamethasone are frequently used in obstetrics to prevent postoperative nausea and vomiting (PONV). However, the superiority of any drug class is yet to be established. This network meta-analysis aimed to compare the efficacy of these antiemetics for PONV prophylaxis in women receiving neuraxial morphine for Caesarean delivery. METHODS: We searched PubMed, Embase, CENTRAL, Web of Science, and Wanfang Data for eligible randomised controlled trials. Primary outcomes were the incidences of postoperative nausea (PON) and postoperative vomiting (POV) within 24 h after surgery. We used a Bayesian random-effects model and calculated odds ratios with 95% credible intervals for dichotomous data. We performed sensitivity and subgroup analyses for primary outcomes. RESULTS: A total of 33 studies with 4238 women were included. In the primary analyses of all women, 5-HT3 antagonists, dopamine antagonists, dexamethasone, and 5-HT3 antagonists plus dexamethasone significantly reduced PON and POV compared with placebo, and 5-HT3 antagonists plus dexamethasone were more effective than monotherapy. In the subgroup analyses, similar results were seen in women receiving epidural morphine or intrathecal morphine alone but not in women receiving intrathecal morphine with fentanyl or sufentanil. However, most included studies had some concerns or a high risk of bias, and the overall certainty of the evidence was low or very low. CONCLUSIONS: Combined 5-HT3 antagonists plus dexamethasone are more effective than monotherapy in preventing PONV associated with neuraxial morphine after Caesarean delivery. Future studies are needed to determine the role of prophylactic antiemetics in women receiving intrathecal morphine and lipophilic opioids. SYSTEMATIC REVIEW PROTOCOL: PROSPERO CRD42023454602.

Comparative efficacy of prophylactic protocols in reducing perioperative nausea and vomiting during video-assisted thoracoscopic radical resection of lung cancer.

Lung cancer, a global mortality leader, often necessitates Video-Assisted Thoracoscopic (VATS) surgery. However, post-operative nausea and vomiting (PONV) is common, highlighting a need for effective management and prevention strategies in this context. A retrospective case-control study at Fujian Medical University Union Hospital evaluated patients undergoing VATS radical resection of lung cancer between May and September 2022. Patients were categorized based on PONV prevention methods, and data encompassing demographics, surgical history, and postoperative adverse events s were analyzed to assess the association between prophylactic protocols and PONV incidence. The Netupitant and Palonosetron Hydrochloride (NEPA) group showed a significant reduction in PONV occurrences post-surgery compared to Ondansetron (ONDA) and Control groups, emphasizing NEPA's efficacy in alleviating PONV symptoms (P < 0.05). Furthermore, following VATS radical resection of lung cancer, NEPA markedly reduced the intensity of PONV symptoms in patients. Both univariate and multivariate logistic analyses corroborated that NEPA independently reduces PONV risk, with its protective effect also apparent in susceptible populations like females and non-smokers. NEPA utilization markedly reduced both the incidence and severity of PONV in patients undergoing VATS radical resection of lung cancer, serving as an independent protective factor in mitigating PONV risk post-surgery.

Comparison of prophylaxis strategy for postoperative nausea and vomiting and its incidence before and after the implementation of 5-hydroxytryptamine 3 in surgical setting: a single-center, retrospective study.

PURPOSE: To investigate the association between adherence to guideline-recommended risk-based postoperative nausea and vomiting (PONV) prophylaxis, the antiemetics used for PONV prophylaxis, and the incidence of PONV in patients who were underwent general anesthesia before and after 5-HT3 receptor antagonists became available. METHODS: Patients (≥ 20 years old) who were extubated after scheduled surgery and returned to general wards between January 2021 and February 2022 and between June 2022 and July 2023 were included. Risk factors included age < 50, female, motion sickness, nonsmoker, surgical factors, and postoperative opioid use. Two and three or more prophylaxis were recommended for patients with one or two and three or more risk factors, respectively. The primary outcome was the number of patients who received adequate prophylaxis, and the secondary outcomes were antiemetic agents used during anesthesia and the incidence of PONV on postoperative days 0 and 1. PONV was defined as documented PONV or rescue antiemetic administration. RESULTS: From January 2021 to February 2022 and from June 2022 to July 2023, 2342 and 2682 patients were included, respectively. Before ondansetron became available, more D2 receptor antagonists were used (p < 0.001), and after ondansetron became available, both ondansetron (p < 0.001) and propofol (p < 0.001) were given more frequently. Before and after ondansetron became available, the number of patients with adequate prophylaxis was 3.7% and 9.2%, respectively (p < 0.001), and the incidence of PONV on postoperative days 0 and 1 was 44.6% and 44.0%, respectively (p = 0.67). CONCLUSION: The availability of ondansetron increased the number of patients with adequate PONV prophylaxis, but did not decrease the incidence of PONV.

The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69).

An objective and validated index of nausea and vomiting such as the Pregnancy-Unique Quantification of Emesis (PUQE) and HyperEmesis Level Prediction (HELP) tools can be used to classify the severity of NVP and HG. [Grade C] Ketonuria is not an indicator of dehydration and should not be used to assess severity. [Grade A] There are safety and efficacy data for first line antiemetics such as anti (H1) histamines, phenothiazines and doxylamine/pyridoxine (Xonvea®) and they should be prescribed initially when required for NVP and HG (Appendix III). [Grade A] There is evidence that ondansetron is safe and effective. Its use as a second line antiemetic should not be discouraged if first line antiemetics are ineffective. Women can be reassured regarding a very small increase in the absolute risk of orofacial clefting with ondansetron use in the first trimester, which should be balanced with the risks of poorly managed HG. [Grade B] Metoclopramide is safe and effective and can be used alone or in combination with other antiemetics. [Grade B] Because of the risk of extrapyramidal effects metoclopramide should be used as second-line therapy. Intravenous doses should be administered by slow bolus injection over at least 3 minutes to help minimise these. [Grade C] Women should be asked about previous adverse reactions to antiemetic therapies. If adverse reactions occur, there should be prompt cessation of the medications. [GPP] Normal saline (0.9% NaCl) with additional potassium chloride in each bag, with administration guided by daily monitoring of electrolytes, is the most appropriate intravenous hydration. [Grade C] Combinations of different drugs should be used in women who do not respond to a single antiemetic. Suggested antiemetics for UK use are given in Appendix III. [GPP] Thiamine supplementation (either oral 100 mg tds or intravenous as part of vitamin B complex (Pabrinex®)) should be given to all women admitted with vomiting, or severely reduced dietary intake, especially before administration of dextrose or parenteral nutrition. [Grade D] All therapeutic measures should have been tried before considering termination of pregnancy. [Grade C].

Effect of preoperative ondansetron on postoperative nausea in healthy dogs undergoing laparoscopic gastropexy and castration.

OBJECTIVE: To investigate if preoperative ondansetron reduces postoperative nausea associated with laparoscopic gastropexy and castration in dogs. STUDY DESIGN: Prospective clinical study. ANIMALS: Twenty client-owned, healthy male dogs. METHODS: Dogs were premedicated with dexmedetomidine (2-5 mcg kg-1) and methadone (0.2-0.5 mg kg-1) intramuscularly. General anesthesia was induced with propofol and maintained with an inhalant anesthetic agent. Dogs were randomized into group S (saline 0.1 mL kg-1, intravenously) or group O (ondansetron 0.2 mg kg-1, intravenously). Plasma and serum were collected before premedication and 3 hours postextubation to measure arginine vasopressin (AVP) and cortisol concentrations. Nausea scoring occurred before and 10 minutes after premedication, immediately after extubation, and at 1, 2 and 3 hours postextubation. Data were analyzed by mixed and split-plot anova with Bonferroni adjustment for the number of group comparisons. Significance was set at p < 0.05. RESULTS: Nausea scores increased over time at 1 (p = 0.01) and 2 (p < 0.001) hours postextubation in both groups compared with before premedication. Median nausea score (0-100 mm) for groups S and O before premedication were 2.5 and 0.5 mm, respectively. At 1 and 2 hours postextubation, group S scored 7.5 and 4.0 mm and group O scored 6.0 and 5.0 mm, respectively. No significant differences in nausea scores within or between groups were observed before premedication and 3 hours postextubation. Cortisol concentrations increased significantly 3 hours postextubation in both groups (p < 0.001) compared with before premedication, with no differences between groups. AVP concentrations showed no significant differences within or between groups. CONCLUSIONS AND CLINICAL RELEVANCE: Preoperative intravenous administration of ondansetron (0.2 mg kg-1) did not impact postoperative nausea after laparoscopic gastropexy and castration. Investigation of higher doses of ondansetron on the incidence of postoperative nausea and vomiting in dogs after surgery is warranted.

Profilaxis antiemética en pacientes con neoplasias hematológicas que reciben protocolos de acondicionamiento para el trasplante de células madre hematopoyéticas: protocolo de estudio para una revisión sistemática / Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review

Objetivo las náuseas y los vómitos inducidos por la quimioterapia siguen siendo un reto importante para los pacientes que recibieron un trasplante de células madre hematopoyéticas. Este estudio tiene como objetivo sintetizar la evidencia disponible sobre los regímenes de profilaxis antiemética en los pacientes con neoplasias hematológicas que recibieron un trasplante de células madre hematopoyéticas, con el fin de identificar el mejor estándar de cuidado. Métodos se llevará a cabo una revisión sistemática utilizando las bases de datos MEDLINE a través de PubMed, EMBASE, Clinical-Trials.gov y Cochrane. Se considerarán los estudios escritos en inglés, francés, italiano o español. Después de seleccionar los estudios de acuerdo con los criterios de inclusión y exclusión, 2 revisores independientes extraerán los datos y evaluarán el riesgo de sesgo en los artículos seleccionados. Este protocolo se ha elaborado de acuerdo con las recomendaciones de las guías PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols). Este protocolo está registrado en PROSPERO (Prospective Register of Ongoing Systematic Reviews) CRD42023406380. Discusión las náuseas y los vómitos inducidos por la quimioterapia son un efecto secundario incapacitante que supone un reto importante para los pacientes con neoplasias hematológicas. A pesar de la publicación de diversas guías sobre profilaxis antiemética, ninguna de ellas incluye recomendaciones específicas para cada régimen de quimioterapia. Por lo tanto, analizar los regímenes de profilaxis antiemética primaria en los pacientes con neoplasias hematológicas que recibieron un trasplante de progenitores hematopoyéticos sería valioso para mejorar la calidad de vida de estos pacientes. (AU)

Objective Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. Methods A systematic review will be conducted using MEDLINE via PubMed, EMBASE, ClinicalTrials.gov., and Cochrane databases. Studies written in English, French, Italian or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, two independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. Discussion Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them includes specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life. (AU)

Guías antieméticas: ¿hemos incorporado los cambios referentes a carboplatino y antraciclinas? / Antiemetic guidelines: Have we incorporated the changes concerning carboplatin and anthracyclines?

Objetivo: en 2016 se publicaron las guías de la MASCC/ESMO que incorporaron los esquemas de antraciclinas como quimioterapia altamente emetógena (QAE) proponiendo la triple terapia antiemética, así como para los esquemas de carboplatino. Los objetivos fueron analizar el nivel de concordancia entre las guías y la profilaxis antiemética utilizada en el hospital de día de hematooncología, evaluar su efectividad y determinar el ahorro de la inclusión de netupitant/palonosetrón (NEPA) oral con dexametasona intravenosa (NEPAd) respecto a fosaprepitant con ondansetrón y dexametasona (FOD intravenosa). Método estudio observacional prospectivo registrando variables demográficas, esquema de quimioterapia recibido, localización tumoral, riesgo emetógeno del paciente, pauta antiemética prescrita, concordancia con guía MASCC/ESMO y su efectividad, utilización de medicación de rescate y registro de visitas a urgencias o ingresos por emesis.Se llevó a cabo un estudio farmacoeconómico de minimización de costes. Resultados se incluyeron 61 pacientes, 70% mujeres, mediana edad 60,5.Los esquemas de platino fueron más frecuentes en el periodo 1, siendo el 87,5% respecto al 67,6% en el periodo 2. Los esquemas con antraciclinas fueron del 21,6 y 10% respectivamente en cada periodo. Un 21,1% de las pautas antieméticas no coincidían con las recomendaciones MASCC/ESMO, siendo en su totalidad en el periodo 1. La puntuación de los cuestionarios de efectividad fue de protección total en el 90,9% en las náuseas agudas, del 100% en los vómitos agudos y en las náuseas retardadas, y del 72,7% en los vómitos retardados. La frecuencia de uso de medicación de rescate fue del 18,7% en el periodo 1 y no fue necesaria en el periodo 2.No se detectaron visitas a urgencias ni ingresos en ninguno de los periodos. El uso de NEPAd comportó una reducción del 28% de los costes con respecto al empleo de FOD. Conclusiones: ... (AU)

Objective: Latest MASCC/ESMO guidelines of the recommendations for the prophylaxis of acute and delayed emesis induced by moderately emetogenic chemotherapy was published in 2016 incorporating anthracycline schemes as highly emetogenic chemotherapy (HEC), proposing triple antiemetic therapy to control nausea and vomiting. Likewise, they recommend triple therapy for carboplatin. The objectives of this study were to analyze the degree of concordance between guidelines and antiemetic prophylaxis used in the Chemotherapy Outpatient Unit in patients undergoing treatment with HEC and carboplatin, to evaluate its effectiveness and to determine the savings due to the use of netupitant/palonosetron (NEPA) oral (or) with intravenous (iv) dexamethasone (NEPAd) compared to iv Fosaprepitant with ondansetron and dexamethasone (FOD iv).MethodsProspective observational study recording demographic variables, chemotherapy protocol, tumor location, patient emetogenic risk, antiemetic regimen prescribed, concordance with the MASCC/ESMO guideline, and effectiveness, evaluated by MASCC survey, use of rescue medication and visits to the Emergency Department or hospitalization due to emesis.A cost minimization pharmacoeconomic study was carried out. Results 61 patients were included; 70% women; median age 60.5. Platinum schemes were more frequent in period 1, being 87.5% compared to 67.6% in period 2. Anthracycline schemes were 21.6% and 10% respectively in each period.A 21.1% of the antiemetic regimens did not coincide with the MASCC/ESMO recommendations, being entirely in period 1. The score of the effectiveness questionnaires was total protection in 90.9% in acute nausea, from 100% in acute vomiting and delayed nausea, and 72.7% in delayed vomiting.The frequency of use of rescue medication was 18.7% in period 1 and was not necessary in period 2.No visits to the emergency room or admissions were detected in any of the periods. Conclusions: ...(AU)

Ondansetrón para el control de vómitos asociados a gastritis y gastroenteritis aguda en urgencias de Pediatría: uso, abuso y buen uso / Ondansetron for the control of vomiting associated with acute gastritis/gastroenteritis in Pediatric Emergencies: use, abuse and appropriate use

Introducción: el ondansetrón es un antiemético ampliamente utilizado en la práctica clínica para el control de vómitos asociados a gastritis y/o gastroenteritis aguda en niños. Sin embargo, la evidencia disponible es controvertida, sus indicaciones no están claramente definidas y no existe una unanimidad de uso en las guías de práctica clínica. Material y métodos: se realizó un estudio de cohortes retrospectivo en el que se incluyó un total de 825 niños entre 0 y 14 años con vómitos asociados a gastritis y/o gastroenteritis aguda que acudieron a Urgencias de Pediatría de un hospital terciario durante el año 2019. Se analizó la asociación entre el uso de ondansetrón y la necesidad de rehidratación intravenosa, las hospitalizaciones, el tiempo de permanencia en Urgencias y las nuevas consultas a Urgencias dentro de las 72 horas posteriores. Resultados: de la muestra estudiada, el 38,8% de los pacientes recibieron ondansetrón. La administración de ondansetrón redujo el riesgo de ingreso (OR 0,19; IC 95%: 0,04-0,84) y disminuyó el tiempo de permanencia en Urgencias (p = 0,000). No se encontraron diferencias significativas en la reducción de la necesidad de rehidratación intravenosa (OR 0,65; IC 95%: 0,40-1,05) ni en las nuevas visitas a Urgencias dentro de las 72 horas siguientes (OR 1,38; IC 95%: 0,82-2,31). Conclusiones: nuestros resultados sugieren que el uso de ondansetrón podría ser beneficioso en niños mayores de 6 meses con vómitos asociados a gastritis y/o gastroenteritis aguda y que presenten deshidratación de leve a moderada (AU)

Background: ondansetron is an antiemetic widely used in clinical practice for the control of vomiting associated with gastritis and/or acute gastroenteritis in children. However, the available evidence about its use is controversial, its directions for use are not clearly defined and there is no unanimity on its use in clinical practice guidelines.Methodology: we performed a retrospective cohort study which included a total of 825 children between 0 and 14 years, who presented symptoms of vomiting associated with gastritis and/or acute gastroenteritis and attended the Pediatric Emergency Department of a tertiary hospital in 2019. The association between the use of ondansetron and the need for intravenous rehydration, hospitalization, length of stay in the Pediatric Emergency Department and return visits to the emergency department within 72 hours was analysed.Results: of the sample studied, 38.7% of the patients received ondansetron. The administration of ondansetron reduced the risk of hospital admission (OR 0.19; 95% CI 0.04 to 0.84) and decreased the length of stay in the emergency department (p = 0.000). No significant differences were found in reducing the need for intravenous rehydration (OR 0.65; 95% CI 0.40 to 1.05) or in return visits to emergency department within 3 days (OR 1.38; 95% CI 0.82-2.31).Conclusions: our results suggest that the use of ondansetron could be beneficial in children older than 6 months with vomiting associated with gastritis and/or acute gastroenteritis and with mild-to-moderate dehydration. (AU)

Simultaneous quantification of sumatriptan succinate and prochlorperazine maleate in orodispersible films using two validated UV-spectroscopic methods.

The study aimed at simultaneous quantification of sumatriptan succinate (SUM) and prochlorperazine maleate (PCP) in an orodispersible film using two validated spectroscopic methods viz. simultaneous equation (Method I) and the Q-absorption ratio (Method II). The Method I involved measurement of absorbances at λmax of both drugs while in Method II, absorbances were measured at isosbestic wavelength and λmax of one of the two components. Method validation were accomplished as per the ICH guidelines. A 1:1 mixture of the drugs and an orodispersible film (ODF) containing these drugs were assayed by both methods. The absorbance data of SUM and PCP in both methods were linear at respective wavelengths with correlation coefficient values >0.995. Both methods were precise as % RSD in repeatability, interday and intraday precision was less than 2. The estimation of SUM and PCP from the film dosage form by method I was104.74% and 98.34% and by method II was 103.45% and 98.85%, respectively, with a standard deviation <2. The study concluded that both the methods were simple, reliable and robust and can be applied successfully for the simultaneous quantification of SUM and PCP in mixture and orodispersible film dosage form.

A phase I trial of lurbinectedin in combination with cisplatin in patients with advanced solid tumors.

Background In vitro/in vivo data showed synergism of cisplatin and lurbinectedin in ovarian cancer cells and grafts. This phase I trial investigated the recommended phase II dose (RD) of cisplatin and lurbinectedin combination, with (Group A) or without aprepitant (Group B), in patients with advanced solid tumors. Patients and Methods All patients received 60 mg/m2 cisplatin 90-min intravenous (i.v.) infusion followed by lurbinectedin 60-min i.v. infusion at escalating doses on Day 1 every 3 weeks (q3wk). Patients in Group A additionally received orally 125 mg aprepitant one hour before cisplatin on Day 1 and 80 mg on Days 2 and 3. Toxicity was graded according to the NCI-CTCAE v.4. Results RD for Group A was cisplatin 60 mg/m2 plus lurbinectedin 1.1 mg/m2. RD for Group B was cisplatin 60 mg/m2 plus lurbinectedin 1.4 mg/m2. The most frequent grade ≥ 3 adverse events were hematological [neutropenia (41%), lymphopenia (35%), leukopenia (24%), thrombocytopenia (18%)] and fatigue (35%) in Group A (n = 17), and neutropenia (50%), leukopenia (42%), lymphopenia (29%), and fatigue (13%) and nausea (8%) in Group B (n = 24). Four patients (2 in each group) had a partial response. Disease stabilization for ≥ 4 months was observed in 4 and 10 patients, respectively. Conclusion The combination of lurbinectedin with cisplatin was not possible in meaningful therapeutic dosage due to toxicity. The addition of aprepitant in combination with cisplatin did not allow increasing the dose due to hematological toxicity, whereas omitting aprepitant increased the incidence of nausea and vomiting. Modest clinical activity was observed in general.Clinical trial registration www.ClinicalTrials.gov code: NCT01980667. Date of registration: 11 November 2013.

Oral Ondansetron Administration in Children Seeking Emergency Department Care for Acute Gastroenteritis: A Patient-Level Propensity-Matched Analysis.

STUDY OBJECTIVE: This study aimed to explore oral ondansetron usage and impact on outcomes in clinical practice. METHODS: This observational study was a planned secondary analysis of 2 trials conducted in 10 US and 6 Canadian institutions between 2014 and 2017. Children 3 to 48 months old with gastroenteritis and ≥3 episodes of vomiting in the 24 hours preceding emergency department (ED) presentation were included. Oral ondansetron was administered at the discretion of the provider. The principal outcomes were intravenous fluid administration and hospitalization at the index visit and during the subsequent 72 hours and diarrhea and vomiting frequency during the 24 hours following the ED visit. RESULTS: In total, 794 children were included. The median age was 16.0 months (interquartile range 10.0 to 26.0), and 50.1% (398/794) received oral ondansetron. In propensity-adjusted analysis (n=528), children administered oral ondansetron were less likely to receive intravenous fluids at the index visit (adjusted odds ratio [aOR] 0.50; 95% confidence interval [CI] 0.29 to 0.88). There were no differences in the frequencies of intravenous fluid administration within the first 72 hours (aOR 0.65; 95% CI 0.39 to 1.10) or hospitalization at the index visit (aOR 0.31; 95% CI 0.09 to 1.10) or the subsequent 72 hours (aOR 0.52; 95% CI 0.21 to 1.28). Episodes of vomiting (aRR 0.86; 95% CI 0.63 to 1.19) and diarrhea (aRR 1.11; 95% CI 0.93 to 1.32) during the 24 hours following ED discharge also did not differ. CONCLUSION: Among preschool-aged children with gastroenteritis seeking ED care, oral ondansetron administration was associated with a reduction in index ED visit intravenous fluid administration; it was not associated with intravenous fluids administered within 72 hours, hospitalization, or vomiting and diarrhea in the 24 hours following discharge.

Dose optimization of intravenous dexamethasone for total knee arthroplasty: when two is not better than one.

BACKGROUND: The optimal dose regimen of dexamethasone in total knee arthroplasty (TKA) has not been determined. This study was performed to evaluate the impact of a single preoperative high-dose dexamethasone compared with two perioperative low-dose dexamethasone in TKA. MATERIALS AND METHODS: We prospectively studied three regimens on dexamethasone: no dexamethasone (A), a single preoperative dose of 20-mg dexamethasone (B), and two perioperative doses of 10-mg dexamethasone (C). The primary outcome was postoperative pain level. The incidence of postoperative nausea and vomiting (PONV), use of analgesic and antiemetic rescue, interleukin-6 (IL-6) and C-reactive protein (CRP) levels, range of motion (ROM), and complications were also compared. RESULTS: The dynamic pain scores and CRP and IL-6 levels were significantly lower for Group B compared to Groups A and C on postoperative days 1 and 2 (POD 1 and 2). Such differences were also detected between Groups C and A. Besides, the pain scores at rest were significantly lower in Groups B and C than in Group A on POD 1 and 2. Patients in Groups B and C had a lower incidence of PONV, reduced use of analgesic and antiemetic rescue, and improved ROM than in Group A. No complications occurred in any group. CONCLUSION: Dexamethasone in TKA provides short-term advantages in analgesic, antiemetic and anti-inflammatory effects. Besides, regarding the effects of pain and inflammatory control on POD 1 and 2, a single preoperative high dose of 20-mg dexamethasone was more effective than two perioperative low doses of 10-mg dexamethasone. LEVEL OF EVIDENCE: I.

Prospective real-time evaluation of the QTc interval variation after low-dose droperidol among emergency department patients.

OBJECTIVE: To assess the QTc interval variation after low-dose droperidol in a population of undifferentiated, stable, and non-agitated patients receiving droperidol in the emergency department. METHODS: Prospective cohort study of patients aged ≥12 years of age who received low-dose droperidol (≤ 2.5 mg) for indications other than acute behavioral disturbances. QTc intervals were monitored in real-time during pre-specified observation periods in the ED. Primary outcome was variation of QTc interval after droperidol administration, defined as the maximum delta (change) of QTc interval. Other outcomes included proportion of patients with a QTc ≥ 500 ms after droperidol, delta ≥ +60 ms, and incidence of clinical adverse events. Patients were monitored up to 30 min after IV bolus and up to 46 min after infusion. RESULTS: A total of 68 patients were included (mean age 42.1 years, 66.2% females). The median dose of droperidol was 1.875 mg (range 0.625 mg, 2.5 mg) and 94.1% received droperidol for headache management. Most patients received droperidol as a 2-min bolus (n = 41, 60.3%). The mean maximum delta of QTc interval after droperidol across all 68 patients was +29.9 ms (SD 15). A total of 12 patients (17.6%) experienced a QTc interval ≥ 500 ms during the observation period after droperidol, and 3 patients (4.4%) had a delta QTc ≥ +60 ms. There were no serious arrhythmias, such as TdP, or deaths among the 68 participants in this study (0/68). However, 13.2% (n = 9) had at least one non-serious adverse event including restlessness and/or anxiety. CONCLUSION: The QTc interval slightly increased after droperidol administration, but these prolongations were brief, mostly below 500 msec and did not lead to serious arrhythmias. The yield of continuous cardiac monitoring in patients receiving low doses of droperidol is likely low.