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1.
BMC Cancer ; 19(1): 1118, 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31730451

RESUMO

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) belong among the most burdensome side effects in hemato-oncology. Mostly, a combination of ondansetron and dexamethasone is used as antiemetic prophylaxis in pediatric patients undergoing emetogenic chemotherapy. However, dexamethasone is prohibited in different pediatric chemotherapy protocols. Currently, data on the use of ondansetron with the new antiemetic agent fosaprepitant without dexamethasone is not available for pediatric patients. METHODS: In this non-interventional observation study, 79 pediatric patients with a median age of 8.0 years (range 0.5-17.9 years) who received a CINV prophylaxis regimen with either fosaprepitant (4 mg/kg; maximum 150 mg) and ondansetron (as 24-h continuous infusion) (n = 40; fosaprepitant group/FG) or ondansetron only (n = 39; control group/CG) during moderately or highly emetogenic chemotherapy were analyzed. The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h-120 h) CINV phases. RESULTS: A total of 112 and 116 chemotherapy blocks were analyzed in the fosaprepitant and the control group, respectively. The emetogenic potential of the administered chemotherapy did not significantly differ (p = 0.8812) between the two cohorts. In the acute CINV phase, the percentage of patients experiencing vomiting (n = 26 patients) and the vomiting events were significantly higher (p = 0.0005 and p < 0.0001, respectively) in the CG (n = 26 patients (66.7%); 88 events) compared with the FG (n = 10 patients (25.0%); 37 events). In the delayed CINV phase, the percentage of patients experiencing vomiting and the vomiting events were also significantly higher (p = 0.0017 and p < 0.0001, respectively) in the CG (n = 31 patients (79.5%); 164 events) compared with the FG (n = 17 patients (42.5%); 103 events). Additionally, significantly more dimenhydrinate doses were administered in the CG compared with the FG patients (n = 322/n = 198; p < 0.0001). The occurrence of adverse events did not significantly differ between the two groups (p > 0.05). CONCLUSION: Fosaprepitant (4.0 mg/kg) in addition to ondansetron, without application of dexamethasone, was well tolerated, safe, effective and superior to ondansetron only as CINV prophylaxis in pediatric patients during moderately and highly emetogenic chemotherapy.


Assuntos
Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Morfolinas/uso terapêutico , Náusea/prevenção & controle , Neoplasias/tratamento farmacológico , Vômito/prevenção & controle , Adolescente , Antieméticos/efeitos adversos , Antineoplásicos/administração & dosagem , Estudos de Casos e Controles , Criança , Pré-Escolar , Estudos de Viabilidade , Feminino , Humanos , Lactente , Masculino , Morfolinas/efeitos adversos , Náusea/induzido quimicamente , Neoplasias/patologia , Ondansetron/efeitos adversos , Ondansetron/uso terapêutico , Segurança do Paciente , Resultado do Tratamento , Vômito/induzido quimicamente
2.
Trials ; 20(1): 517, 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31429811

RESUMO

BACKGROUND: Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality of life and loss of work productivity. Ondansetron, a 5HT3 receptor antagonist, has had an excellent safety record for over 20 years as an antiemetic, yet is not widely used in the treatment of IBS-D. It has, however, been shown to slow colonic transit and in a small randomised, placebo-controlled, cross-over pilot study, benefited patients with IBS-D. METHODS: This trial is a phase III, parallel group, randomised, double-blind, multi-centre, placebo-controlled trial, with embedded mechanistic studies. Participants (n = 400) meeting Rome IV criteria for IBS-D will be recruited from outpatient and primary care clinics and by social media to receive either ondansetron (dose titrated up to 24 mg daily) or placebo for 12 weeks. Throughout the trial, participants will record their worst abdominal pain, worst urgency, stool frequency, and stool consistency on a daily basis. The primary endpoint is the proportion of "responders" in each group, using Food and Drug Administration (FDA) recommendations. Secondary endpoints include pain intensity, stool consistency, frequency, and urgency. Mood and quality of life will also be assessed. Mechanistic assessments will include whole gut transit, faecal tryptase and faecal bile acid concentrations at baseline and between weeks 8 and 11. A subgroup of participants will also undergo assessment of sensitivity (n = 80) using the barostat, and/or high-resolution colonic manometry (n = 40) to assess motor patterns in the left colon and the impact of ondansetron. DISCUSSION: The TRITON trial aims to assess the effect of ondansetron across multiple centres. By defining ondansetron's mechanisms of action we hope to better identify patients with IBS-D who are likely to respond. TRIAL REGISTRATION: ISRCTN, ISRCTN17508514 , Registered on 2 October 2017.


Assuntos
Antidiarreicos/uso terapêutico , Diarreia/tratamento farmacológico , Síndrome do Intestino Irritável/tratamento farmacológico , Ondansetron/uso terapêutico , Antagonistas do Receptor 5-HT3 de Serotonina/uso terapêutico , Antidiarreicos/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Diarreia/diagnóstico , Diarreia/etiologia , Diarreia/fisiopatologia , Método Duplo-Cego , Humanos , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/diagnóstico , Síndrome do Intestino Irritável/fisiopatologia , Estudos Multicêntricos como Assunto , Ondansetron/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Antagonistas do Receptor 5-HT3 de Serotonina/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Reino Unido
4.
Reprod Toxicol ; 83: 14-20, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30385129

RESUMO

This study investigates risk of specific structural birth defects associated with ondansetron exposure during the first trimester in a large US commercially-insured population. Medical claims data were obtained from Truven Health Analytics for 864,083 mother-infant pairs from 2000 to 2014. Logistic regression was used to measure the association between first trimester exposure to ondansetron and risk of cardiac defects, orofacial clefts and other specific structural defects in offspring. First trimester exposure to ondansetron was associated with increased risk of cardiac (OR: 1.52 95% CI: 1.35-1.70) and orofacial cleft defects (OR: 1.32 95% CI: 0.76-2.28) in offspring compared to women with no antiemetic exposure during pregnancy. This analysis addresses limitations of prior studies including limited power, exposure misclassification, and generalizability to the US population. In a large, US population we found a statistically significant association between early pregnancy ondansetron exposure and specific structural birth defects in offspring.


Assuntos
Antieméticos/efeitos adversos , Anormalidades Congênitas/epidemiologia , Ondansetron/efeitos adversos , Adulto , Feminino , Humanos , Masculino , Troca Materno-Fetal , Razão de Chances , Gravidez , Primeiro Trimestre da Gravidez
5.
JAMA ; 320(23): 2429-2437, 2018 12 18.
Artigo em Inglês | MEDLINE | ID: mdl-30561479

RESUMO

Importance: Evidence for the fetal safety of ondansetron, a 5-HT3 receptor antagonist that is commonly prescribed for nausea and vomiting during pregnancy, is limited and conflicting. Objective: To evaluate the association between ondansetron exposure during pregnancy and risk of congenital malformations. Design, Setting, and Participants: A retrospective cohort study nested in the 2000-2013 nationwide Medicaid Analytic eXtract. The cohort consisted of 1 816 414 pregnancies contributed by 1 502 895 women enrolled in Medicaid from 3 months before the last menstrual period through 1 month or longer after delivery; infants were enrolled in Medicaid for at least 3 months after birth. The final date of follow-up was December 31, 2013. Analyses were conducted between November 1, 2017, and June 30, 2018. Propensity score stratification was used to control for treatment indication and other confounders. Exposures: Ondansetron dispensing during the first trimester, the period of organogenesis. Main Outcomes and Measures: Primary outcomes were cardiac malformations and oral clefts diagnosed during the first 90 days after delivery. Secondary outcomes included congenital malformations overall and subgroups of cardiac malformations and oral clefts. Results: Among 1 816 414 pregnancies (mean age of mothers, 24.3 [5.8] years), 88 467 (4.9%) were exposed to ondansetron during the first trimester. Overall, 14 577 of 1 727 947 unexposed and 835 of 88 467 exposed infants were diagnosed with a cardiac malformation, for an absolute risk of 84.4 (95% CI, 83.0 to 85.7) and 94.4 (95% CI, 88.0 to 100.8) per 10 000 births respectively. The absolute risk of oral clefts was 11.1 per 10 000 births (95% CI, 10.6 to 11.6; 1921 unexposed infants) and was 14.0 per 10 000 births (95% CI, 11.6 to 16.5; 124 exposed infants). The risk of any congenital malformation was 313.5 per 10 000 births (95% CI, 310.9 to 316.1; 54 174 unexposed infants) and was 370.4 (95% CI, 358.0 to 382.9; 3277 exposed infants). The adjusted relative risk (RR) for cardiac malformations was 0.99 (95% CI, 0.93 to 1.06) and the adjusted risk difference (RD) was -0.8 (95% CI, -7.3 to 5.7 per 10 000 births). For oral clefts, the adjusted RR was 1.24 (95% CI, 1.03 to 1.48) and the RD was 2.7 (95% CI, 0.2 to 5.2 per 10 000 births). The adjusted estimate for congenital malformations overall was an RR of 1.01 (95% CI, 0.98 to 1.05) and an RD of 5.4 (95% CI, -7.3 to 18.2 per 10 000 births). Conclusions and Relevance: Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders but was associated with a small increased risk of oral clefts.


Assuntos
Anormalidades Induzidas por Medicamentos/etiologia , Antieméticos/efeitos adversos , Fenda Labial/induzido quimicamente , Fissura Palatina/induzido quimicamente , Cardiopatias Congênitas/induzido quimicamente , Náusea/tratamento farmacológico , Ondansetron/efeitos adversos , Complicações na Gravidez/tratamento farmacológico , Adulto , Antieméticos/uso terapêutico , Feminino , Humanos , Recém-Nascido , Ondansetron/uso terapêutico , Gravidez , Primeiro Trimestre da Gravidez , Pontuação de Propensão , Estudos Retrospectivos , Risco , Vômito/tratamento farmacológico , Adulto Jovem
6.
Ginekol Pol ; 89(8): 453-58, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30215466

RESUMO

BACKGROUND: Hemodynamic change during spinal anaesthesia for cesarean section is prevalent. OBJECTIVE: Comparing the prophylactic effects of ephedrine, ondansetron and ringer on hemodynamic changes in patients undergoing cesarean section with spinal anaesthesia. MATERIAL AND METHODS: This randomized clinical trial was carried out on pregnant women undergoing elective cesarean sec-tion referred to teaching hospitals of Mashhad, Iran. Patients allocated to three groups of intravenous ondansetron (O) (4 mg, 5 min),intramuscular ephedrine (E) (25 mg, 25 min) and ringer (R) (500 ml, 20 min) prior to spinal anaesthesia. Anaesthesia inducted with 10-15 mg of bupivacaine. Vital signs were recorded every 3 minutes for 18 minutes including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse rate (PR), pulse oximetry (SpO2). RESULTS: Ninety patients with a mean age of 29.4 ± 5.4 years were studied in three groups of O (n = 30), E (n = 30), R (n = 30). Results showed a statistically significant difference in the incidence rate of hypotension 12 minutes after spinal anaesthesia in the three groups, but no statistically significant difference was found in the rest of minutes among the three groups. Dur-ing follow-up minutes, bradycardia was observed in only one patient (1.1%) of Group O and no cases of this sign were observed in other minutes and other groups. CONCLUSION: Intramuscular administration of ephedrine 25 minutes prior to the spinal anaesthesia leads to better prevention of systolic blood pressure changes compared with intravenous ondansetron and ringer, while administration of ondansetron and ringer had the same effects on reducing hemodynamic changes.


Assuntos
Agonistas Adrenérgicos/administração & dosagem , Anestesia Obstétrica/métodos , Raquianestesia/métodos , Cesárea/métodos , Epinefrina/administração & dosagem , Hemodinâmica/efeitos dos fármacos , Ondansetron/administração & dosagem , Solução de Ringer/administração & dosagem , Antagonistas do Receptor 5-HT3 de Serotonina/administração & dosagem , Agonistas Adrenérgicos/efeitos adversos , Adulto , Anestesia Obstétrica/efeitos adversos , Raquianestesia/efeitos adversos , Pressão Arterial/efeitos dos fármacos , Cesárea/efeitos adversos , Epinefrina/efeitos adversos , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Irã (Geográfico) , Ondansetron/efeitos adversos , Gravidez , Solução de Ringer/efeitos adversos , Antagonistas do Receptor 5-HT3 de Serotonina/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
7.
J Glob Oncol ; 4: 1-9, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30241275

RESUMO

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a distressing adverse effect. Neurokinin-1 receptor antagonist (NK1RA)-containing regimens are the standard regimens for CINV prophylaxis in patients with cancer receiving highly or moderately emetogenic chemotherapy (HEC or MEC). NK1RA agents are expensive and were not registered in Sudan. Recently, regimens containing olanzapine, the available and affordable medication in Sudan, were introduced as another option. This study aimed to compare the efficacy of an olanzapine-containing regimen with the antiemetic regimen that was currently used in our institute for CINV prophylaxis in HEC/MEC settings. PATIENTS AND METHODS: The study prospectively compared an olanzapine-containing regimen (acute phase: olanzapine, ondansetron, dexamethasone; delayed phase: olanzapine, ondansetron) with an ondansetron/dexamethasone regimen (acute phase: ondansetron, dexamethasone; delayed phase: ondansetron) in adult patients with cancer receiving HEC or MEC. The study outcomes were complete response (CR; no emesis and no rescue medications) and nausea control (no nausea), which were assessed in the acute (0 to 24 hours), delayed (24 to 120 hours), and overall (0 to 120 hours) phases. RESULTS: The study included 131 patients (olanzapine-containing: 50 patients; ondansetron/dexamethasone: 81 patients). CR and nausea control were higher in the olanzapine-containing than in the ondansetron/dexamethasone regimen (CR: acute phase, 86% v 71.6%; P = .086; delayed phase, 72% v 30.9%; P < .001; overall phase, 66% v 25.9%; P < .001; nausea control: acute phase, 86% v 74.1%; P = .127; delayed phase, 76% v 34.6%; P < .001; overall phase, 72% v 29.6%; P < .001). The major toxicity of olanzapine was grade 1 and 2 sedation or drowsiness (25 patients). CONCLUSION: An olanzapine-containing regimen has better efficacy for prevention of CINV in the HEC/MEC setting. Oncologists working in a limited-resource setting should be familiar with olanzapine-containing regimens, because NK1RA agents are not affordable and not easily available.


Assuntos
Náusea/epidemiologia , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Vômito/epidemiologia , Adulto , Idoso , Antieméticos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Dexametasona/efeitos adversos , Dexametasona/uso terapêutico , Tratamento Farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Humanos , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Náusea/patologia , Neoplasias/patologia , Olanzapina/efeitos adversos , Olanzapina/uso terapêutico , Ondansetron/efeitos adversos , Ondansetron/uso terapêutico , Receptores da Neurocinina-1 , Sudão/epidemiologia , Vômito/induzido quimicamente , Vômito/patologia , Adulto Jovem
8.
Biomed Res Int ; 2018: 1024324, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29977907

RESUMO

Objective: 5-HT3 receptor antagonist (ondansetron) has been reported to have nephrotoxic effect when combined with cisplatin in mice; however, little evidence exists in explaining its nephrotoxic effects on patients. The aim of this present study was to investigate whether 5-HT3 receptor antagonist could enhance or aggravate the incidence of cisplatin-induced nephrotoxicity in patients. Methods: We retrospectively reviewed 600 tumor patients which were treated with cisplatin (⩾60 mg/m2) as a first-time chemotherapy and combined with 5-HT3 receptor antagonist (i.e., ondansetron, tropisetron, or ramosetron, each kind of 5-HT3 receptor antagonist contains 200 cases) between January 2010 and December 2015. Cisplatin dosing, the baseline creatinine clearance, and other independent risk factors such as patient's age, sex, PS score, and weight associated with nephrotoxicity were evaluated in a multivariable model. Results: The incidence of Grade ⩾ 2 serum creatinine elevation in cisplatin + ondansetron group was significantly higher than cisplatin + tropisetron group (P = 0.04), but no significant difference was found between cisplatin + ondansetron group and cisplatin + ramosetron group (P = 0.3). It was also found that cisplatin dosage and tumor type were independent risk factors in the development of nephrotoxicity. Conclusion: Higher cisplatin dosage and regular use of ondansetron combined with cisplatin are more likely to increase the incidence of nephrotoxicity; tropisetron showed the relatively mild effect on kidney function, suggesting that tropisetron is a preferable alternative in the process of cisplatin chemotherapy.


Assuntos
Antieméticos/efeitos adversos , Antineoplásicos/efeitos adversos , Cisplatino/efeitos adversos , Rim/efeitos dos fármacos , Ondansetron/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Animais , Feminino , Humanos , Rim/fisiopatologia , Masculino , Camundongos , Pessoa de Meia-Idade , Receptores 5-HT3 de Serotonina , Estudos Retrospectivos , Antagonistas do Receptor 5-HT3 de Serotonina/efeitos adversos , Antagonistas da Serotonina , Vômito , Adulto Jovem
9.
Obstet Gynecol ; 132(2): 385-394, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29995744

RESUMO

OBJECTIVE: To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, either previously reported or undescribed, between first-trimester ondansetron use and major birth defects. METHODS: We used data from two case-control studies, the National Birth Defects Prevention Study (1997-2011) and the Slone Birth Defects Study (1997-2014). The prevalence of ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy among control patients was calculated in 2-year intervals. Using women with untreated first-trimester nausea and vomiting of pregnancy as the reference, we calculated adjusted odds ratios (ORs) and 95% CIs for associations between first-trimester ondansetron use for treatment of nausea and vomiting of pregnancy and specific birth defects. A secondary exposure group of other prescription antiemetics was used to address confounding by indication. RESULTS: In the National Birth Defects Prevention Study and Slone Birth Defects Study, respectively, 6,751 and 5,873 control mothers and 14,667 and 8,533 case mothers who reported first-trimester nausea and vomiting of pregnancy were included in the analysis. Among women in the control group, ondansetron exposure increased from less than 1% before 2000 to 13% in 2013-2014. Ondansetron use was not associated with an increased risk for most of the 51 defect groups analyzed. Modest increases in risk were observed for cleft palate (adjusted OR 1.6, 95% CI 1.1-2.3) in the National Birth Defects Prevention Study and renal agenesis-dysgenesis (adjusted OR 1.8, 95% CI 1.1-3.0) in the Birth Defects Study, although these findings may be the result of chance. CONCLUSION: Off-label use of ondansetron for the treatment of nausea and vomiting of pregnancy increased to 13% by the end of the study period. For the majority of specific birth defects investigated, there was no increased risk associated with first-trimester use of ondansetron for treatment of nausea and vomiting of pregnancy compared with no treatment, although modest associations with cleft palate and renal agenesis-dysgenesis warrant further study.


Assuntos
Anormalidades Induzidas por Medicamentos/etiologia , Antieméticos/efeitos adversos , Êmese Gravídica/tratamento farmacológico , Ondansetron/efeitos adversos , Complicações na Gravidez/tratamento farmacológico , Anormalidades Induzidas por Medicamentos/epidemiologia , Adulto , Antieméticos/uso terapêutico , Estudos de Casos e Controles , Esquema de Medicação , Feminino , Humanos , Recém-Nascido , Masculino , Razão de Chances , Ondansetron/uso terapêutico , Gravidez , Primeiro Trimestre da Gravidez , Fatores de Risco , Estados Unidos/epidemiologia
10.
J Obstet Gynaecol Can ; 40(7): 910-918, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29754832

RESUMO

OBJECTIVE: Ondansetron, not approved for use in pregnancy, is increasingly being prescribed for nausea and vomiting in pregnancy and hyperemesis gravidarum. A number of recent lawsuits have highlighted the possibility that ondansetron may cause congenital malformations. The aim of this study was to systematically review epidemiological evidence on the potential association of prenatal exposure to ondansetron and congenital malformations. METHODS: Systematic searches in Medline and Embase were performed in June 2017 using controlled vocabulary and key words, and references of search results were reviewed. Full papers (RCTs, cohort, and case-control studies) were eligible for inclusion if they reported fetal outcomes of prenatal ondansetron exposure in humans. Excluded were: case reports, studies involving pre-medication with ondansetron prior to CS, animal studies, and foreign languages studies. RESULTS: Ten epidemiologic studies were included: five large retrospective cohort studies, two prospective observational studies, two population-based case-controls. and a retrospective case series. Sample sizes ranged from 17 to 1 501 434 infants exposed to ondansetron. A case-control study identified an association between prenatal exposure to ondansetron and cleft palate, and one cohort study found an increased risk of cardiovascular defects. These findings were not reproduced in the other studies. CONCLUSION: While further investigation of the literature is needed, our results highlight the paucity of evidence linking prenatal exposure to ondansetron to an increased risk of congenital malformations. There is a need for additional epidemiologic studies to confirm whether ondansetron represents a safe and effective alternative treatment for nausea and vomiting in pregnancy and hyperemesis gravidarum.


Assuntos
Antieméticos/efeitos adversos , Anormalidades Congênitas/epidemiologia , Hiperêmese Gravídica/tratamento farmacológico , Ondansetron/efeitos adversos , Cuidado Pré-Natal , Anormalidades Congênitas/etiologia , Feminino , Humanos , Gravidez , Fatores de Risco
11.
Eur J Anaesthesiol ; 35(12): 966-971, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29746373

RESUMO

BACKGROUND: Akathisia, a distressing movement disorder induced by butyrophenones, has been described with low doses of droperidol used for postoperative nausea and vomiting (PONV) prophylaxis, but the incidence remains unclear. OBJECTIVES: To determine the incidence of akathisia after PONV prophylaxis with two doses of droperidol in comparison with ondansetron, in patients undergoing ambulatory surgery. We hypothesised that the incidence of akathisia is higher with droperidol than that with ondansetron. DESIGN: Randomised controlled double blind trial. SETTING: Two University Hospital Centres and two private Clinics from January to September 2014. PATIENTS: Patients (n=297) undergoing general anaesthesia for ambulatory surgery were randomly allocated to receive PONV prophylaxis with droperidol (0.625 or 1.25 mg) or ondansetron 4 mg; patients of the three groups also received 4 mg of dexamethasone. Exclusion criteria were contraindication to droperidol and ondansetron, use of psychotropic medications or benzodiazepines or history of psychotic illness. INTERVENTIONS: Participants received droperidol (0.625 or 1.25 mg) or ondansetron 4 mg during general anaesthesia. After discharge from the postanaesthesia care unit presence and severity of akathisia were assessed using the Barnes Akathisia Rating Scale at 4 h postoperatively. MAIN OUTCOME MEASURES: Score of the Global Clinical Assessment of Akathisia of Barnes Akathisia Rating Scale. RESULTS: The number of akathisia observed was 1/118 (0.8%) in the ondansetron group, 1/84 (1.2%) in droperidol 0.625 mg group, and 3/87 (3.4%) in droperidol 1.25 mg group. The akathisia rate difference among the three groups was not significant (P = 0.52). We could not demonstrate significant differences in the incidence of akathisia between the two doses of droperidol. The only case of marked akathisia treated with benzodiazepines was observed after droperidol 1.25 mg. CONCLUSION: The use of droperidol or ondansetron for PONV prophylaxis is associated to a low incidence of akathisia (0.8 to 3.4%) after general anaesthesia for ambulatory surgery. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01942343.


Assuntos
Acatisia Induzida por Medicamentos/epidemiologia , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Droperidol/efeitos adversos , Ondansetron/efeitos adversos , Profilaxia Pós-Exposição , Náusea e Vômito Pós-Operatórios/epidemiologia , Adulto , Acatisia Induzida por Medicamentos/diagnóstico , Procedimentos Cirúrgicos Ambulatórios/tendências , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Método Duplo-Cego , Droperidol/administração & dosagem , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Ondansetron/administração & dosagem , Profilaxia Pós-Exposição/tendências , Náusea e Vômito Pós-Operatórios/diagnóstico , Náusea e Vômito Pós-Operatórios/prevenção & controle
12.
Br J Clin Pharmacol ; 84(5): 1077-1080, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29520857

RESUMO

A 30-year-old pregnant female presented with a 2-week history of pityriasis rosea-like eruption. The rash started 2 days after the patient had started taking ondansetron 8 mg for alleviation of moderate-to-severe nausea and vomiting of pregnancy. Physical examination revealed erythematous papulosquamous lesions characterized by annular scaly margins and a dusky centre over the arms, chest, abdomen, lower back and legs. The rash did not involve the palms, sole or mucous membranes, and no lesions were observed on the lymph nodes. Ondansetron was discontinued. The rash ceased to spread and started to disappear within 2 weeks with full resolution noted after 1 month. Analysis of the case using the Naranjo adverse drug reaction probability scale indicated that ondansetron was the probable cause of the pityriasis rosea-like eruption. This is the first case report of pityriasis rosea related to ondansetron therapy.


Assuntos
Antieméticos/efeitos adversos , Ondansetron/efeitos adversos , Pitiríase Rósea/induzido quimicamente , Complicações na Gravidez/induzido quimicamente , Adulto , Feminino , Humanos , Gravidez
14.
J Cutan Pathol ; 45(5): 365-368, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29430677

RESUMO

Injection drug abuse (IDA) is known to cause a spectrum of systemic and cutaneous complications. Despite the increasing incidence of IDA around the world, there is a paucity of literature discussing cutaneous complications from a dermatopathologic perspective. We present a case of a 35-year-old male with a complex medical history of Von Willebrand disease, Beçhet disease and diverticular disease. Following a sigmoidectomy/colostomy for diverticular perforation, he presented with fever and an indurated right arm displaying livedoid purpura. The right distal fingertips showed purpura with focal ulceration. A punch biopsy of the right wrist did not show evidence of inflammatory vasculitis or pyogenic infection, but instead showed a focus of polarizing, refractile material occluding a dilated arterial lumen within the mid-dermis. The patient admitted to injecting a suspension of crushed ondansetron (Zofran) tablets into the antecubital area to control post-operative nausea. It is known that direct intravascular injection of foreign material can cause distal ischemia and necrosis, either by local vasoconstriction, thrombosis, or formation of microemboli, as in this patient. Our objective is to bring awareness to this rarely reported phenomenon, and to raise clinical suspicion for IDA when confronted with such a unique vasculopathic pattern.


Assuntos
Antieméticos/administração & dosagem , Corpos Estranhos/etiologia , Injeções Intra-Arteriais/efeitos adversos , Ondansetron/administração & dosagem , Uso Indevido de Medicamentos sob Prescrição/efeitos adversos , Adulto , Antieméticos/efeitos adversos , Doença Diverticular do Colo/complicações , Doença Diverticular do Colo/cirurgia , Embolia/etiologia , Corpos Estranhos/patologia , Humanos , Masculino , Ondansetron/efeitos adversos , Oxicodona/administração & dosagem , Oxicodona/efeitos adversos , Náusea e Vômito Pós-Operatórios/prevenção & controle , Comprimidos/efeitos adversos
15.
Am J Health Syst Pharm ; 75(5): 276-282, 2018 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-29317399

RESUMO

PURPOSE: Results of a study to determine whether i.v. administration of a single dose of 4 mg of ondansetron was associated with QT interval prolongation in emergency department (ED) patients are reported. METHODS: In a prospective observational study conducted at an urban academic medical center ED, a convenience sample of adult ED patients treated with ondansetron 4 mg i.v. were enrolled. A 12-lead electrocardiogram (ECG) was obtained immediately before and 5 minutes after ondansetron administration. Measurements of heart rate-corrected QT interval (QTc measurements) provided by ECG machines were evaluated. An electrophysiologist analyzed all ECGs for adverse electrical events and verified the accuracy of QTc values. The primary objective was to measure the QTc change from baseline after ondansetron administration. The secondary objective was to describe adverse electrical cardiac events. Interactions between ondansetron and patients' home medications or ED-provided medications were analyzed. RESULTS: Among patients included in the data analysis (n = 20), ondansetron administration was associated with a mean QTc increase of 16.2 msec (95% confidence interval, 4.2-28.2 msec; p = 0.01) and a median increase of 12 msec (interquartile range, 5.5-18.0 msec; p < 0.01). One patient had a significant cardiac event (pulseless electrical activity) that was likely unrelated to ondansetron use. The home medications of 9 patients (42.9%) were deemed to pose a risk of torsades de pointes, and 17 major QT-prolonging drug-drug interactions were identified. CONCLUSION: Significant QTc prolongation occurred in ED patients receiving a single 4-mg i.v. dose of ondansetron. None of the patients had an ondansetron-related cardiac adverse event.


Assuntos
Ansiolíticos/administração & dosagem , Eletrocardiografia/efeitos dos fármacos , Serviço Hospitalar de Emergência , Frequência Cardíaca/efeitos dos fármacos , Ondansetron/administração & dosagem , Administração Intravenosa , Adulto , Ansiolíticos/efeitos adversos , Eletrocardiografia/tendências , Serviço Hospitalar de Emergência/tendências , Frequência Cardíaca/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Ondansetron/efeitos adversos , Estudos Prospectivos
16.
Pediatr Emerg Care ; 34(1): 38-41, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27261956

RESUMO

OBJECTIVE: Ondansetron improves the success of oral rehydration in children with gastroenteritis. In postoperative adults, ondansetron has been shown to prolong the corrected QT (QTc). The aim of the study was to evaluate the effect of ondansetron on the QT at peak effect and at 1-hour postpeak effect in pediatric patients. METHODS: This was an observational study looking at patients aged 6 months to 18 years receiving intravenous ondansetron for nausea, vomiting, or the inability to take fluids in the emergency department. Patients had electrocardiogram performed at baseline, at ondansetron's peak effect, and 1 hour postpeak effect. A paired samples Student t test compared QTc change at peak effect to zero. Peak effect of intravenous ondansetron is 3 minutes. RESULTS: One hundred patients were included. Fifty-five percent of patients were female with a mean age of 8.3 years. The mean (range) baseline QTc was 435 (388 to 501) milliseconds. The mean (range) change in QTc at peak effect of ondansetron was 3 (-40 to 65) milliseconds (P = 0.072). The change in QTc 1-hour postpeak effect of ondansetron was 3 (-43 to 45) milliseconds (P = 0.082). No change at peak effect or 1-hour postpeak effect was clinically significant. CONCLUSIONS: Ondansetron does not affect the QTc of pediatric patients receiving the medication for nausea, vomiting, or inability to take fluids in the emergency department. No changes in the QTc are clinically significant. To date, there have been no studies evaluating the effect of ondansetron in this acutely ill population; therefore, a larger study should be completed to confirm these data.


Assuntos
Antieméticos/efeitos adversos , Eletrocardiografia/efeitos dos fármacos , Síndrome do QT Longo/induzido quimicamente , Ondansetron/efeitos adversos , Adolescente , Antieméticos/uso terapêutico , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Síndrome do QT Longo/epidemiologia , Masculino , Ondansetron/uso terapêutico , Projetos Piloto , Vômito/tratamento farmacológico
17.
Pediatr Blood Cancer ; 65(2)2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28941006

RESUMO

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) in children remains to be a major side effect despite antiemetic treatment. Palonosetron is a new generation 5-HT3 receptor antagonists effective against acute and delayed nausea and vomiting. This study aimed to compare the therapeutic values of palonosetron and ondansetron in preventing pediatric CINV. METHODS: A prospective, randomized, double-blind, parallel controlled study was conducted in 0-18 years old cancer patients administered highly emetogenic chemotherapy, with different dosage of palonosetron or ondansetron, both followed by dexamethasone. The patients were observed for vomiting and nausea from 0 to 120 hr after chemotherapy initiation. All adverse events (AEs) during the study period were recorded. This study was registered with the Chinese Clinical Trial Registry, number ChiCTR-TRC-14004891. RESULTS: Between August 2014 and July 2016, 565 patients were randomly assigned to receive 5 µg/kg palonosetron (n = 185), 10 µg/kg palonosetron (n = 186), and 3 × 150 µg/kg ondansetron (n = 194), of whom 181, 185, and 189, respectively, were included in the efficacy analysis. Complete response (CR) rates during the acute phase were 69.1, 69.7, and 64.6%, respectively, in the 5 µg/kg palonosetron, 10 µg/kg palonosetron, and ondansetron groups. In the delayed phase, 10 µg/kg palonosetron (CR, 53.5%) showed superiority to 5 µg/kg palonosetron (CR, 39.8%) and ondansetron (CR, 32.8%) groups (P < 0.05). The most frequently observed drug-related AEs were nervous system disorders, mainly headache, with an incidence of 2.8, 2.2, and 2.6% in each group, respectively. CONCLUSION: Combination of palonosetron plus dexamethasone is highly effective in controlling acute and delayed CINV, with palonosetron superior to ondansetron.


Assuntos
Antieméticos/administração & dosagem , Isoquinolinas/administração & dosagem , Náusea/tratamento farmacológico , Ondansetron/administração & dosagem , Quinuclidinas/administração & dosagem , Vômito/tratamento farmacológico , Adolescente , Antieméticos/efeitos adversos , Criança , Pré-Escolar , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Lactente , Recém-Nascido , Isoquinolinas/efeitos adversos , Masculino , Náusea/induzido quimicamente , Neoplasias/tratamento farmacológico , Ondansetron/efeitos adversos , Palonossetrom , Estudos Prospectivos , Quinuclidinas/efeitos adversos , Vômito/induzido quimicamente
18.
J Oncol Pharm Pract ; 24(7): 537-539, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28682150

RESUMO

Pipamperon is a potent neuroleptic drug with many side effects, including prolongation of the QT interval. We report a case of a child treated for leukemia in which prolongation of the QT interval was observed. Physicians and pharmacists should be cautious for drug-drug interactions when pipamperon is prescribed, especially in combination with other QT-prolongating agents. Alternative strategies should be used whenever possible.


Assuntos
Butirofenonas/efeitos adversos , Síndrome do QT Longo/induzido quimicamente , Ondansetron/efeitos adversos , Butirofenonas/administração & dosagem , Criança , Interações Medicamentosas , Eletrocardiografia/efeitos dos fármacos , Humanos , Leucemia/tratamento farmacológico , Masculino , Ondansetron/administração & dosagem
19.
Am J Emerg Med ; 36(5): 754-757, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29029798

RESUMO

BACKGROUND: The potential for ondansetron to cause QT prolongation and fatal dysrhythmia is well-reported, including a 2011 FDA report on the topic. Few clinical trials evaluating this phenomenon in the ED setting exist, and only one is pediatric. OBJECTIVE: We have sought to determine the effect of a standardized dose of intravenous ondansetron on the QTc duration of children under 14years of age treated for gastroenteritis-associated vomiting in a pediatric ED. This study is modeled closely after an FDA "thorough QT study". METHODS: EGCs were obtained before and 15, 30, 45, and 60min after a 0.15mg/kg IV dose of ondansetron given for gastroenteritis-associated vomiting. QT intervals were measured manually with digital calipers, and the QTc interval calculated both by Bazett's (QTcB) and Fridericia's (QTcF) correction. A paired t-test comparing QTc was conducted, and frequency of categorical outcomes of prolongation>30msec, >60 msec, and absolute prolongation >450 msec, >480 msec, and >500msec were evaluated. RESULTS: In a 4-month period, 134 patients were included in the study, 46% were male. The average QTc prior to ondansetron administration was: QTcB 415 msec (95% CI 343-565) and QTcF 373 (95% CI 304-499). The mean difference in QTc after ondansetron was 0.4msec for QTcB (95% CI -35-45msec) and 0.1msec for QTcF (95% CI -40-18msec). CONCLUSION: In these children, 0.15mg/kg of intravenous ondansetron did not cause prolongation of QTcB or QTcF measured 15min after administration, nor at later times.


Assuntos
Antieméticos/administração & dosagem , Gastroenterite/complicações , Frequência Cardíaca/efeitos dos fármacos , Síndrome do QT Longo/induzido quimicamente , Ondansetron/administração & dosagem , Vômito/etiologia , Administração Intravenosa , Adolescente , Antieméticos/efeitos adversos , Criança , Pré-Escolar , Eletrocardiografia , Serviços Médicos de Emergência , Feminino , Humanos , Masculino , Ondansetron/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Vômito/tratamento farmacológico
20.
Tex Heart Inst J ; 44(5): 366-369, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29259513

RESUMO

Drugs that prolong the electrocardiographic QT interval increase the risk of ventricular arrhythmias, particularly torsades de pointes. Ondansetron, a 5-hydroxytryptamine type 3 receptor antagonist antiemetic, is one such drug. We present the cases of 2 patients who were given intravenous ondansetron and subsequently developed torsades de pointes. Both had normal QT intervals at baseline but were discovered to have risk factors that predisposed them to drug-induced QT prolongation and ventricular arrhythmias. We briefly review the mechanisms for torsades de pointes caused by QT-prolonging medications, describe characteristics that increase patients' susceptibility to drug-induced QT prolongation, and call attention to the risk of ventricular arrhythmias in patients who are given ondansetron.


Assuntos
Eletrocardiografia/efeitos dos fármacos , Ondansetron/efeitos adversos , Torsades de Pointes/induzido quimicamente , Feminino , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Ondansetron/administração & dosagem , Antagonistas da Serotonina/administração & dosagem , Antagonistas da Serotonina/efeitos adversos , Torsades de Pointes/fisiopatologia
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