Randomized Clinical Trial of Metoclopramide as Prophylaxis of Gastroesophageal Reflux Disease in Preterm Infants.

BACKGROUND: Gastroesophageal reflux (GER) is more frequent in premature infants. Metoclopramide was introduced routinely in premature babies followed in ambulatory care by the Colombian Kangaroo Mother Care program (KMCP), based on a 2004 Cochrane review. AIM: Because of the recent controversy on the use of metoclopramide in children, this study was conducted to evaluate the effectiveness and safety of metoclopramide given as GER disease (GERD) prophylaxis. METHODS: A randomized clinical trial was conducted between April 2017 and January 2019 in 466 premature infants discharged home and followed at a KMCP. Double-blind allocation to metoclopramide versus placebo was performed, 0.2 mg/kg three times daily, administered 15 min before feeding, up to term. Exclusion criteria were oxygen dependency, any perinatal neurological problem or parent's participation refusal. The incidence of GERD symptoms and adverse events that could be associated with the use of metoclopramide were recorded by parents weekly (e.g., emesis, cyanosis or apnea, post-prandial crying episodes, extrapyramidal symptoms, tremor, and drowsiness). RESULTS: A total of 466 subjects were recruited, most of them late preterm. The groups' baseline characteristics were similar. Median duration of the intervention was approximately 3 weeks, at which time most patients were at term. In the longitudinal mixed effects analysis, we did not find clinically significant differences in GERD-related symptoms between groups, either in minor or severe side effects. CONCLUSION: Results show absence of effectiveness in the systematic use of metoclopramide as prophylaxis of GERD symptoms in premature infants. Additionally, no adverse effects attributable to the drug were found. ClinicalTrials.gov: NCT02907632; September 20, 2016. Retrospectively registered.

[Extrapyramidal adverse reactions to metoclopramide. A pharmacovigilance survey]. / Farmacovigilancia activa de metoclopramida 10 mg oral en pacientes del Programa de Alivio del Dolor y Cuidados Paliativos o diabetes mellitus tipo 2 en cinco hospitales del Servicio de Salud Viña del Mar-Quillota.

BACKGROUND: In 2013 the Chilean regulatory sanitary agency issued a warning concerning dose adjustment and use restriction to avoid severe adverse effects of metoclopramide such tardive dyskinesia. AIM: To study dyskinesia type adverse effects in a population using metoclopramide. MATERIAL AND METHODS: A cross sectional observational study was conducted among patients pertaining to palliative care and diabetes mellitus programs and consuming 10 mg/day or more of metoclopramide. Patients were interrogated looking for extrapiramidal signs and symptoms using a questionnaire validated by two neurologists. RESULTS: In 40% of diabetic patients with gastroparesia and 35% of palliative care patients, extrapyramidal adverse reactions to metoclopramide were suspected. Palliative Care patients suffered the largest number of adverse events. The period of use and individual doses of the drug were largely above Chilean regulatory agency recommendations in all cases. CONCLUSIONS: A significant number of patients using metoclopramide could experience extrapyramidal adverse reactions.

Farmacovigilancia activa de metoclopramida 10 mg oral en pacientes del Programa de Alivio del Dolor y Cuidados Paliativos o diabetes mellitus tipo 2 en cinco hospitales del Servicio de Salud Viña del Mar-Quillota / Extrapyramidal adverse reactions to metoclopramide: a pharmacovigilance survey

Background: In 2013 the Chilean regulatory sanitary agency issued a warning concerning dose adjustment and use restriction to avoid severe adverse effects of metoclopramide such tardive dyskinesia. Aim: To study dyskinesia type adverse effects in a population using metoclopramide. Material and Methods: A cross sectional observational study was conducted among patients pertaining to palliative care and diabetes mellitus programs and consuming 10 mg/day or more of metoclopramide. Patients were interrogated looking for extrapiramidal signs and symptoms using a questionnaire validated by two neurologists. Results: In 40% of diabetic patients with gastroparesia and 35% of palliative care patients, extrapyramidal adverse reactions to metoclopramide were suspected. Palliative Care patients suffered the largest number of adverse events. The period of use and individual doses of the drug were largely above Chilean regulatory agency recommendations in all cases. Conclusions: A significant number of patients using metoclopramide could experience extrapyramidal adverse reactions.

Efectos extrapiramidales por metoclopramida en embarazo y recién nacido / Extrapyramidal effects for metoclopramide in pregnancy and newborn

Las náuseas y la emesis son complicaciones posoperatorias que pueden derivar en bronco aspiración, una situación clínica potencialmente fatal. Para su prevención, se usan medicamentos como la metoclopramida. Se presenta un reporte de caso de extrapiramidalismo por metoclopramida en el recién nacido y la madre. Es una reacción secundaria a un medicamento, clasificada como un evento serio y definitivo, de tipo A. Se requiere considerar el balance entre riesgo y beneficio de este medicamento en este tipo de condiciones, como también considerar otras medidas que eviten estos casos. El reporte de reacciones adversas a medicamentos es una actividad que contribuye al uso seguro de los medicamentos.

Postoperative nauseas and vomiting are complications that can lead to bronchoaspiration, a potentially fatal clinical event. Medications such as metoclopramide are used to prevent them. A case report of extrapyramidal signs in a newborn and mother metoclopramide is presented. It has been classified as a serious drug reaction, type A. The risk-benefit balance of this drug in such conditions should be considered as well as other measures to prevent such events. The reporting of adverse drug reactions is an activity that contributes to the safe use of medicines.

Analysis of agreement between Visual Analogue Scales (VAS) and numerical questions to assess perception of teratogenic risks in treatment with drugs and radiotherapy in women / Análise de concordância entre as escalas visual analógica (VAS) e questões numéricas para avaliar a percepção de riscos teratogênicos em tratamento com medicamentos e radioterapia em mulheres

To evaluate the agreement between Visual Analogue Scales (VAS) and numerical questions as a way of assessing the perception of teratogenic risk of treatment with drugs and radiotherapy. Methods: the sample comprised 144 pregnant and 143 non-pregnant women consecutively recruited at public health centers in Porto Alegre, in the State of Rio Grande do Sul, from February to August 2011. The perception of risk for congenital malformations in the general population and the perceptions of teratogenic risk for exposure to acetaminophen, meto-clopramide, misoprostol and radiotherapy were measured using VAS and numerical questions. The agreement between the results of the two techniques was tested using a Bland-Altman plot. Results: the medians for the perceptions measured using VAS were higher than those obtained using numerical questions for all variables. The perception of risk for acetaminophen showed the lower bias of the two techniques (bias=13.17; p<0.001) and exposure to radiotherapy, the higher (bias=25.02; p<0.001). Conclusion: there was no agreement between the measurements obtained using the two techniques for any of the risk perceptions under study. Risk perceptions were higher using VAS, for all kinds of exposure. Studies should be conducted to assess whether there is overestimation in other situations and social contexts owing to the use of VAS...

Avaliar a concordância entre Escalas Visuais Analógicas (EVA) e perguntas numéricas para aferir a percepção de risco teratogênico de medicamentos e radioterapia. Métodos: a amostra foi constituída por 144 gestantes e 143 não gestantes recrutadas consecutivamente em centros públicos de saúde de Porto Alegre, RS, entre fevereiro e agosto de 2011. A percepção de risco de malformações congênitas na população geral e as percepções de risco teratogênico das exposições a paracetamol, metoclo-pramida, misoprostol e radioterapia na gestação foram aferidas por EVA e perguntas numéricas. A concordância entre as duas técnicas foi avaliada pela análise gráfica de Bland-Altman Resultados: as medianas das percepções de risco teratogênico medidas por EVA foram superiores às obtidas através da pergunta numérica, para todas as variáveis. A percepção de risco ao paracetamol apresentou o menor viés entre as duas técnicas de aferição (viés=13,17; p<0,001) e a exposição à radioterapia, o maior (viés=25,02;p<0,001). Conclusões: não houve concordância entre as duas técnicas, para nenhuma das percepções de risco estudadas. As percepções de risco foram maiores para EVA, para todas as exposições. Sugerimos a realização de estudos que avaliem se também ocorre superestimação em outras situações e contextos sociais, em função do uso de EVA...

QTc prolongation after brain surgery.

OBJECTIVE: Abnormalities observed in the electrocardiogram (ECG) after acute central nervous system (CNS) events have been reported. Our objective was to assess the incidence of heart rate-corrected QT interval (QTc) prolongation in patients admitted to the intensive care unit (ICU) after brain surgery. METHODS: Admission standard 12-lead ECGs were analyzed blinded to patient data. The QT interval was measured and Bazzett's formula was used to obtain QTc. Prolonged QTc was defined as ≧450 ms. RESULTS: We included 114 patients in the study. The mean age was 49±17 years. Brain neoplasm was the surgical indication in 90% of the patients. The mean QTc was 470±42 ms. Prolonged QTc was found in 71% patients. The heart rate-corrected QT interval was between 450 ms and 500 ms in 52% and >500 ms in 19% of the patients. The heart rate and concentration of serum glucose were higher in the prolonged QTc group. Only 7·5% of all patients had hypokalemia (≤3 mEq/l). In the prolonged QTc group 9·2% had hypokalemia compared to 3·2% in normal QTc patients (P = 0·406). There were no significant associations between categories of QTc and the serum levels of creatinine, magnesium, calcium, sodium, or pH. Phenytoin and metoclopramide were not frequently used in patients with prolonged QTc. DISCUSSION: This study supports our hypothesis that prolonged QTc is frequently observed after a brain surgery. Hypokalemia, hypocalcaemia, and drugs such as metoclopramide or phenytoin could not explain the high incidence of prolonged QTc. Brain injury during a surgical procedure may be one of the primary causes of QTc prolongation after neurosurgery.

Comparison of the pharmacokinetics of a new 30 mg modified-release tablet formulation of metoclopramide for once-a-day administration versus 10 mg immediate-release tablets: a single and multiple-dose, randomized, open-label, parallel study in healthy male subjects.

The study aimed to assess the pharmacokinetics of a new, modified-release metoclopramide tablet, and compare it to an immediate-release tablet. A single and multiple-dose, randomized, open-label, parallel, pharmacokinetic study was conducted. Investigational products were administered to 26 healthy Hispanic Mexican male volunteers for two consecutive days: either one 30 mg modified-release tablet every 24 h, or one 10 mg immediate-release tablet every 8 h. Blood samples were collected after the first and last doses of metoclopramide. Plasma metoclopramide concentrations were determined by high-performance liquid chromatography. Safety and tolerability were assessed through vital signs measurements, clinical evaluations, and spontaneous reports from study subjects. All 26 subjects were included in the analyses [mean (SD) age: 27 (8) years, range 18-50; BMI: 23.65 (2.22) kg/m², range 18.01-27.47)]. Peak plasmatic concentrations were not statistically different with both formulations, but occurred significantly later (p < 0.05) with the modified-release form [tmax: 3.15 (1.28) vs. 0.85 (0.32) h and tmax-ss: 2.92 (1.19) vs. 1.04 (0.43) h]. There was no difference noted in the average plasma concentrations [Cavgτ: 23.90 (7.90) vs. 20.64 (7.43) ng/mL after the first dose; and Cavg-ss: 31.14 (9.64) vs. 35.59 (12.29) ng/mL after the last dose, (p > 0.05)]. One adverse event was reported in the test group (diarrhea), and one in the reference group (headache). This study suggests that the 30 mg modified-release metoclopramide tablets show features compatible with slow-release formulations when compared to immediate-release tablets, and is suitable for once-a-day administration.

Does metoclopramide impair anastomotic healing of the left colon of rats?

PURPOSE: To evaluate the effects of metoclopramide on the formation of adhesion and the healing of left colonic anastomoses in rats. METHODS: Forty rats underwent sectioning of the left colon and end-to-end anastomosis and were divided into two groups of 20 animals for the administration of metoclopramide (experimental group - E) or saline solution (control group - C). Each group was divided into subgroups of 10 animals each to be killed on the third (E3 and C3) or seventh postoperative day (E7 and C7). Adhesion was assessed, and a colonic segment containing the anastomosis was removed for analysis of breaking strength and hydroxyproline concentration. RESULTS: There were no deaths or dehiscence on the 3(rd) postoperative day. There was one death and one blocked anastomotic dehiscence in the E7 group. No significant differences between groups were found in the analysis of clinical outcome, intra-cavity adhesion, adhesion to the anastomosis or breaking strength on the 3(rd) and 7(th) postoperative day. Hydroxyproline concentration was higher in the control group on the 3(rd) (p=0.006) but not on the 7(th) postoperative day (p=0.241). CONCLUSION: Metoclopramide did not have harmful effects on the healing of intestinal anastomoses in rats.

Does metoclopramide impair anastomotic healing of the left colon of rats? / A metoclopramida prejudica a cicatrização de anastomoses do cólon esquerdo de ratos?

PURPOSE: To evaluate the effects of metoclopramide on the formation of adhesion and the healing of left colonic anastomoses in rats. METHODS: Forty rats underwent sectioning of the left colon and end-to-end anastomosis and were divided into two groups of 20 animals for the administration of metoclopramide (experimental group - E) or saline solution (control group - C). Each group was divided into subgroups of 10 animals each to be killed on the third (E3 and C3) or seventh postoperative day (E7 and C7). Adhesion was assessed, and a colonic segment containing the anastomosis was removed for analysis of breaking strength and hydroxyproline concentration. RESULTS: There were no deaths or dehiscence on the 3rd postoperative day. There was one death and one blocked anastomotic dehiscence in the E7 group. No significant differences between groups were found in the analysis of clinical outcome, intra-cavity adhesion, adhesion to the anastomosis or breaking strength on the 3rd and 7th postoperative day. Hydroxyproline concentration was higher in the control group on the 3rd (p=0.006) but not on the 7th postoperative day (p=0.241). CONCLUSION: Metoclopramide did not have harmful effects on the healing of intestinal anastomoses in rats.

OBJETIVO: Avaliar os efeitos da metoclopramida sobre a formação de aderências e a cicatrização de anastomoses de cólon esquerdo de ratos. MÉTODOS: 40 ratos distribuídos em dois grupos contendo 20 animais, para administração de metoclopramida (grupo experimental - E) ou solução de NaCl 0,9 por cento (grupo controle - C). Cada grupo foi dividido em subgrupos contendo 10 animais, para eutanásia no terceiro (E3 e C3) ou sétimo dia (E7 e C7) de pós-operatório. Os ratos foram submetidos à secção do cólon esquerdo e anastomose término-terminal. No dia da re-laparotomia foi avaliada a quantidade total de aderências e removido um segmento colônico contendo a anastomose para análise da força de ruptura e concentração de hidroxiprolina. RESULTADOS: Não houve mortes ou deiscências no 3º dia de pós-operatório. No grupo E7 ocorreram uma morte e uma deiscência de anastomose bloqueada. Não houve diferença significativa entre os grupos em relação à evolução clínica, quantidade de aderências intra-cavitárias ou à anastomose e resistência tênsil no 3º ou 7º pós-operatório. A concentração de hidroxiprolina foi maior no grupo metoclopramida no 3º (p=0,006) mas não no 7º dia de pós-operatório (p=0,241) CONCLUSÃO: A metoclopramida não apresenta efeito deletério sobre a cicatrização de anastomoses intestinais em ratos.

La metoclopramida y sus reacciones adversas sobre el sistema nervioso central / The metoclopramide and its adverse reactions on the nervous central system

Introducción: la metoclopramida ha pasado a ser entre el año 2000 y 2006 el fármaco que con mayor frecuencia se asocia con las discinesias tardías atendidas. En un análisis realizado por Food and Drug Administration se advierte que el 20 por ciento de los pacientes a los que se les prescribe metoclopramida, la utilizan por de más de 3 meses. Objetivo: caracterizar las reacciones adversas a la metoclopramida reportadas y su relación con la notificación de discinesia tardía en nuestro país. Métodos: se realizó un estudio observacional, descriptivo, transversal de farmacovigilancia, que utilizó el método de notificación espontánea de reportes de reacciones adversas a medicamentos y la base de datos de la Unidad Coordinadora Nacional de Farmacovigilancia. Se analizaron todos los reportes de reacciones adversas medicamentosas desde el año 2003 a 2008 procedentes de todo el país. Resultados: se analizaron 1 119 notificaciones de reacciones adversas medicamentosas. Los sistemas de órganos más afectados fueron el sistema nervioso central (43,2 por ciento), seguido del aparato cardiovascular (14,2 por ciento). Predominaron las reacciones adversas medicamentosas probables (73,6 por ciento) y leves (51,7 por ciento), un 0,4 por ciento se correspondió con reacciones adversas graves, mientras que las más frecuentes fueron: extrapiramidalismo (29,0 por ciento), mareos (18,2 por ciento) y temblor (9,9 por ciento). La secuencia temporal entre la ocurrencia de la reacción adversa y la toma del medicamento que predominó fue en horas (53,8 por ciento). Conclusiones: se evidenció que la población pediátrica y geriátrica muestra mayor relación con el predominio de reacciones adversas a medicamentos del sistema nervioso central, no obstante la población adulta no debe quedar excluida, pues más de la mitad de las reacciones adversas a medicamentos del sistema nervioso central reportadas ocurrieron en este grupo de edad. Ese sistema fue el más afectado, aun sin estar relacionadas con dosis elevadas. Las discinesias reportadas pueden ser clasificadas como tempranas o agudas, y las reacciones adversas que predominaron fueron las leves y probables.(AU)

Introduction: metoclopramide from 2000 to 2006 years became the drug with higher frequency of association with late dyskinesia seen. In a analysis carried out by Food and Drug Administration (FDA) it is noticed that the 20 percent of patients with a prescription of metoclopramide use it drug for more than 3 months. Objective: to characterize the adverse reactions reported of metoclopramide and its relation to the notification of a late dyskinesia in our country. Methods: a cross-sectional, descriptive, observational study related to pharmacosurveillance using the method of spontaneous notification of reports on drug adverse reactions and the database of the National Coordination Unit of Pharmacosurveillance. Authors analyzed all reports of drug adverse react ions from 2003 to 2008 from all country. Results: a total of 1 119 notifications of drug adverse reactions. The organic system more involved were the central nervous system (43,2 percent) followed by the cardiovascular one (14,2 percent). There was predominance of probable drug adverse reactions (73,6 percent) and slights (51,7 percent), a 0,4 percent accounted for severe adverse reactions, whereas the more frequent were: extrapyramidal syndrome (29,0 percent), dizziness (18,2 percent) and shaking (9,9 percent). The predominant temporary sequence between the occurrence of adverse reaction and drug ingestion was in hours (53,8 percent). Conclusions: it was evidenced that children and elderly populations show a great relation with the predominance of drug adverse reactions of central nervous system, however, the adult population must not to be excluded, since more than a half of above mentioned reported reactions were in this age group. That system was the more involved even though there was not a link with high doses. The reported dyskinesias may be classified as early or acute and the adverse reactions predominant were the slight and probable ones.(AU)

La metoclopramida y sus reacciones adversas sobre el sistema nervioso central / The metoclopramide and its adverse reactions on the nervous central system

Introducción: la metoclopramida ha pasado a ser entre el año 2000 y 2006 el fármaco que con mayor frecuencia se asocia con las discinesias tardías atendidas. En un análisis realizado por Food and Drug Administration se advierte que el 20 por ciento de los pacientes a los que se les prescribe metoclopramida, la utilizan por de más de 3 meses. Objetivo: caracterizar las reacciones adversas a la metoclopramida reportadas y su relación con la notificación de discinesia tardía en nuestro país. Métodos: se realizó un estudio observacional, descriptivo, transversal de farmacovigilancia, que utilizó el método de notificación espontánea de reportes de reacciones adversas a medicamentos y la base de datos de la Unidad Coordinadora Nacional de Farmacovigilancia. Se analizaron todos los reportes de reacciones adversas medicamentosas desde el año 2003 a 2008 procedentes de todo el país. Resultados: se analizaron 1 119 notificaciones de reacciones adversas medicamentosas. Los sistemas de órganos más afectados fueron el sistema nervioso central (43,2 por ciento), seguido del aparato cardiovascular (14,2 por ciento). Predominaron las reacciones adversas medicamentosas probables (73,6 por ciento) y leves (51,7 por ciento), un 0,4 por ciento se correspondió con reacciones adversas graves, mientras que las más frecuentes fueron: extrapiramidalismo (29,0 por ciento), mareos (18,2 por ciento) y temblor (9,9 por ciento). La secuencia temporal entre la ocurrencia de la reacción adversa y la toma del medicamento que predominó fue en horas (53,8 por ciento). Conclusiones: se evidenció que la población pediátrica y geriátrica muestra mayor relación con el predominio de reacciones adversas a medicamentos del sistema nervioso central, no obstante la población adulta no debe quedar excluida, pues más de la mitad de las reacciones adversas a medicamentos del sistema nervioso central reportadas ocurrieron en este grupo de edad. Ese sistema fue el más afectado, aun sin estar relacionadas con dosis elevadas. Las discinesias reportadas pueden ser clasificadas como tempranas o agudas, y las reacciones adversas que predominaron fueron las leves y probables.

Introduction: metoclopramide from 2000 to 2006 years became the drug with higher frequency of association with late dyskinesia seen. In a analysis carried out by Food and Drug Administration (FDA) it is noticed that the 20 percent of patients with a prescription of metoclopramide use it drug for more than 3 months. Objective: to characterize the adverse reactions reported of metoclopramide and its relation to the notification of a late dyskinesia in our country. Methods: a cross-sectional, descriptive, observational study related to pharmacosurveillance using the method of spontaneous notification of reports on drug adverse reactions and the database of the National Coordination Unit of Pharmacosurveillance. Authors analyzed all reports of drug adverse react ions from 2003 to 2008 from all country. Results: a total of 1 119 notifications of drug adverse reactions. The organic system more involved were the central nervous system (43,2 percent) followed by the cardiovascular one (14,2 percent). There was predominance of probable drug adverse reactions (73,6 percent) and slights (51,7 percent), a 0,4 percent accounted for severe adverse reactions, whereas the more frequent were: extrapyramidal syndrome (29,0 percent), dizziness (18,2 percent) and shaking (9,9 percent). The predominant temporary sequence between the occurrence of adverse reaction and drug ingestion was in hours (53,8 percent). Conclusions: it was evidenced that children and elderly populations show a great relation with the predominance of drug adverse reactions of central nervous system, however, the adult population must not to be excluded, since more than a half of above mentioned reported reactions were in this age group. That system was the more involved even though there was not a link with high doses. The reported dyskinesias may be classified as early or acute and the adverse reactions predominant were the slight and probable ones.

Eficacia de la metoclopramida y la dexametasona en la prevención de naúseas y vómitos postoperatorios en pacientes sometidos a cirugía laparoscópica / Efficacy of metoclopramide and dexamethasone in preventing postoperative nausea and vomiting in patients undergoing laparoscopic surgery

Las náuseas y los vómitos postoperatorios (NVPO) son una complicación frecuente de la anestesia y cirugía y que se presentan en el 20 a 30% de los casos. Objetivo. Demostrar que la frecuencia de NVPO son menores con la asociación de metoclopramida y dexametasona (Met-Dex) en comparación con metoclopramida sola (Met), en pacientes sometidos a cirugía laparoscópica bajo anestesia general. Materiales y métodos. Se realizó un estudio prospectivo, comparativo, aleatorizado y doble ciego, en 82 pacientes sometidos a cirugía laparoscópica bajo anestesia general, divididos al azar en dos grupos: uno tratado con Met-Dex, y el otro con Met. Después del procedimiento anestésico-quirúrgico se evaluaron durante doce horas del postoperatorio (1, 6 y 12 horas), frecuencia de NVPO, así como presencia de efectos secundarios debidos a los fármacos estudiados. Resultados: El grupo Met, en la 1, 6 y 72 horas del postoperatorio no presentaron manifestaciones eméticas, el 95,1%, 53,7% y el 24,4% de los pacientes respectivamente. El grupo Met-Dex, en la 1,6 y 12 horas del postoperatorio no presentaron manifestaciones eméticas, el 100%, 97,6% y el 78,0% de los pacientes respectivamente. Existiendo diferencia significativa entre los resultados (p < 0,05). Como efectos secundarios, con Met-Dex se registraron rubor facial, ardor y prurito perineal. No se registraron efectos secundarios con Met (p < 0,05). Conclusiones: El uso de Met-Dex presenta mayor eficacia para la prevención de NVPO.

Postoperative nausea and vomiting (PONV) are one of the most frequent anesthetic and surgery complications with an incidence rate of 20-30%. Objective: Show that the frequency of PONV are lower with the association of metoclopramide and dexamethasone (Met-Dex) in comparison with metoclopramide alone (Met) in patients undergoing surgeries under general anesthesia laparoscopic. Methodology: Realized study was prospective, comparative, randomized and double blind study in 82 patients undergoing laparoscopic surgeries under general anesthesia were randomly divided into two groups: one treated with Met-Dex, and another with Met. After of processing anesthetic-surgical were evaluated for twelve hours after surgery (1,6 and 12 hours), frequency of nausea and vomiting, well as presence of side effects due to pharmaceutical studied. Results: The group with Met in the 1st, 6th and 12th hours postoperatively showed no manifestations emetic's, 95,1%, 53,7% and 24,4% of patients, respectively. The group Met-Dex, in the 1st, 6th and 72th hours postoperatively showed no manifestations emetic's, 100%, 97,6% and 78,0% of patients, respectively. There are Significant differences between the results (p < 0,05). As side effects, with Met-Dex were flushing, itching, burning and perineal. There weren't side effects with Met (P < 0,05). Conclusions: The use of Met-Dex is more effective for the preventing of PONV.

Comparação de dipirona intravenosa com metoclopramida intravenosa no tratamento de crise aguda de enxaqueca: ensaio clínico randomizado / Comparison of intravenous dipyrone to intravenous metoclopramide in the treatment of acute crisis of migraine: randomized clinical trial

INTRODUÇÃO: A enxaqueca é uma das doenças mais comuns da prática clínica. OBJETIVO: Comparar o efeito analgésico da dipirona com a metoclopramida no alívio da dor. MÉTODO: Conduzimos um estudo piloto randomizado comparando dipirona intravenosa com metoclopramida intravenosa em 27 pacientes apresentando crise de enxaqueca. O objetivo primário foi comparar a redução da intensidade da dor até 2 horas, assim como efeitos colaterais. RESULTADOS: Os grupos tinham faixas etárias semelhantes, mas diferença entre os sexos. Nos homens a metoclopramida reduziu a dor em 80,0 por cento contra 55,0 por cento da dipirona (p=0,052). Já nas mulheres houve uma redução de 65,0 por cento com a metoclopramida e 71,2 por cento com a dipirona (p=0,748). Esses resultados podem ter sido influenciados pelo reduzido número de pacientes no estudo. Não foram encontrados efeitos colaterais significativos. CONCLUSÃO: Não houve diferença quanto à redução da dor nem quanto ao surgimento de efeitos colaterais quando comparados dipirona com metoclopramida.

INTRODUCTION: Migraine is one of the commonest diseases of clinical practice. OBJETIVE: To compare the analgesic effect of dipyrone to metoclopramide in the relief of pain. METHOD: We conducted a pilot randomized study comparing intravenous dipyrone to intravenous metoclopramide in 27 patients presenting acute crisis of migraine. The primary end point was to compare reduction of intensity of pain up to 2 hours, as well as the development of collateral effects. RESULTS: The groups had similar ages, but there were difference between the sexes. In men, metoclopramide reduced pain in 80.0 percent compared with 55.0 percent from dipyrone (p=0.052). In women, there was a reduction of 65.0 percent with metoclopramide and 71.2 percent with dipyrone (p=0.748). The small number of patients in the study might have influenced these results. Significant collateral effects were not found. CONCLUSION: There was no difference about the intensity of pain reduction neither about the development of collateral effects comparing dipyrone to metoclopramide.

[Comparison of intravenous dipyrone to intravenous metoclopramide in the treatment of acute crisis of migraine: randomized clinical trial]. / Comparação de dipirona intravenosa com metoclopramida intravenosa no tratamento de crise aguda de enxaqueca: ensaio clínico randomizado.

INTRODUCTION: Migraine is one of the commonest diseases of clinical practice. OBJECTIVE: [corrected] To compare the analgesic effect of dipyrone to metoclopramide in the relief of pain. METHOD: We conducted a pilot randomized study comparing intravenous dipyrone to intravenous metoclopramide in 27 patients presenting acute crisis of migraine. The primary end point was to compare reduction of intensity of pain up to 2 hours, as well as the development of collateral effects. RESULTS: The groups had similar ages, but there were difference between the sexes. In men, metoclopramide reduced pain in 80.0% compared with 55.0% from dipyrone (p=0.052). In women, there was a reduction of 65.0% with metoclopramide and 71.2% with dipyrone (p=0.748). The small number of patients in the study might have influenced these results. Significant collateral effects were not found. CONCLUSION: There was no difference about the intensity of pain reduction neither about the development of collateral effects comparing dipyrone to metoclopramide.

Efeito da metoclopramida sobre a produção leiteira de porcas no puerpério e o ganho de peso dos leitões / Effect of metoclopramide on sow's milk production and the performance of piglets

A metoclopramida vem sendo utilizada em mulheres como terapia para incremento lactogênico não havendo na literatura informações sobre a utilização desta droga em suínos. O estudo objetivou, avaliar os efeitos da metoclopramida na produção de leite e desempenho da leitegada. Foram utilizadas 12 fêmeas suínas, as quais foram homogeneizadas de acordo com a ordem de parto. A padronização das leitegadas foi estabelecida em 10 leitões por fêmea, totalizando 120 leitões. O delineamento experimental foi inteiramente casualizado caracterizado por medidas repetidas no tempo, sendo definidos dois tratamentos com seis respectivos cada. No tratamento controle (T1) foi feita a aplicação intra-muscular de soro fisiológico nos três primeiros dias pós-parto e no tratamento 2 (T2) foi aplicado metoclopramida. A metoclopramida influenciou significativamente (p < 0,05) na produção de leite, nos três primeiros dias, havendo maior produção em relação ao controle. Não houve diferenças significativas quanto ao ganho de peso dos leitões nas faixas etárias avaliadas, havendo diferença significativa (p < 0,05) no peso dos leitões no 7° dia de vida. Destacou-se no estudo maior homogeneidade e menor dispersão da leitegada proveniente das fêmeas tratadas com metoclopramida, evidenciados pelos valores máximos e mínimos observados aos 21 dias de idade (p < 0,06). Concluiu-se que a metoclopramida provocou aumento do aporte lactacional em fêmeas suínas, nos três primeiros dias de lactação, cujo efeito traduziu-se na melhor homogeneidade da leitegada.(AU)

Metoclopramide has been used in humans as a therapy to increase milk production. There is no information available about this drug in swine for the same purpose. The objective of the study was to evaluate the effects of metoclopramide on lactation of swine females and litter development. For this reason 12 females were used in this study. They were assigned in two graups (T1 and T2) and were drug-induced farrowing. T1 females received saline solution during three days after farrowing and T2 group received metoclopramide. The experimental period lasted 42 days starting fram the administration of the drug. Metoclopramide significantly (p <0,05) affected milk praduction at the first three days compared to the control females. Inthe study we found greater homogeneity and smaller dispersion of litter weight fram females treated with metoclopramida, based upon piglet weight at 21 days of age. In conclusion metoclopramide induced higher milk praduction in swine on the first tree days oflactation and affected litter homogeneity.(AU)