Ensaio cl?nico randomizado, controlado, comparando os resultados da bromoprida, metoclopramida e ondansetron aplicados intramuscular em dose ?nica para o tratamento de v?mitos em um pronto socorro pedi?trico

Autor: Portela, Janete de Lourdes
Jazyk: portugalština
Rok vydání: 2015
Předmět:
Zdroj: Biblioteca Digital de Teses e Dissertações da PUC_RSPontifícia Universidade Católica do Rio Grande do SulPUC_RS.
Druh dokumentu: Doctoral Thesis
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Objective: To compare the effectiveness of single-dose intramuscular bromopride, metoclopramide, and ondansetron for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency for the treatment of vomiting in a pediatric emergency department setting. department setting. department setting. department setting. department setting. department setting.department setting. Methods: Randomized controlled trial of children who presented with vomiting due to gastroenteritis at the pediatric emergency department of Hospital Universit?rio de Santa Maria from August 2013 to June 2014. Children aged 1 to 12 years were randomized to receive a single intramuscular dose of bromopride or metoclopramide (up to 10 mg) or ondansetron (up to 8 mg) 0.15 mg/kg. After administration of the antiemetic drug, children remained under observation for at least 1 hour. Children who were discharged after the observation period were subsequently monitored by their parents or caregivers at home for 24 hours and contacted via telephone for assessment of the results of antiemetic therapy. The following parameters were compared across treatment groups: time to cessation of vomiting within 1, 6, and 24 hours; acceptance of oral rehydration therapy; intravenous fluid replacement; return to hospital; and adverse effects attributable to the antiemetic. All parents or caregivers were given information on the antiemetic treatment that would be provided and signed an informed consent form authorizing the child's participation in the study. Results: Of 180 children randomized, 175 completed the trial. Within 1 hour of antiemetic administration, cessation of vomiting had been achieved in 96.6% of children given bromopride, 94.8% of those given metoclopramide, and 100% of those given ondansetron (p=0.312). Six hours after administration, bromopride was found to cease vomiting in 216?114 minutes, metoclopramide in 150?168 minutes, and ondansetron in 72?54 minutes (p=0.011). Cessation of vomiting at 24 hours was achieved in 67.8% of children given bromopride, 67.2% of those given metoclopramide, and 96.6% of those given ondansetron (p=0.002). Children in the ondansetron group accepted more fluid replenishment orally (200 ml) than those given bromopride or metoclopramide (150 ml and 100 ml respectively) (p=0.034). Eleven children ultimately required intravenous fluids: five in the bromopride group and six in the metoclopramide group. Within 1 hour of antiemetic administration, only 24.1% of children in the ondansetron group reported adverse effects (somnolence, diarrhea, fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot) fatigue, restlessness, feeling hot)fatigue, restlessness, feeling hot), whereas 42.4% and 44.8% of children in the bromopride and metoclopramide groups respectively reported somnolence (p=0.034). At 24 hours, there were no significant differences in adverse effects across the three groups (p=0.357). Conclusion: In a pediatric emergency department setting, ondansetron is superior to bromopride and metoclopramide for treatment of vomiting. Ondansetron was associated with cessation or reduction of vomiting both within 1 hour of administration and at 6 and 24 hours. Bromopride and metoclopramide were both effective, but were associated with somnolence, an adverse effect that can prolong observation time in the emergency department and thus increase hospital costs.
Objetivo: Avaliar os resultados dos antiem?ticos aplicados via intramuscular, bromoprida, metoclopramida e ondansetron em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o em dose ?nica para o tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto tratamento de v?mitos em um pronto socorro socorro socorro pedi?trico. pedi?trico. pedi?trico. pedi?trico. M?todos: Ensaio cl?nico randomizado e controlado, envolvendo crian?as que consultaram por v?mitos, devido ? gastroenterite, no servi?o de Emerg?ncia Pedi?trica no Hospital Universit?rio de Santa Maria, no per?odo de agosto de 2013 a junho de 2014. Foram randomizadas crian?as com idades entre 1 a 12 anos, para receber dose ?nica de bromoprida via intramuscular ou metoclopramida via intramuscular (m?ximo 10mg); ou ondansetron (m?ximo 8mg) na dose de 0,15mg/kg via intramuscular. A crian?a ap?s receber o antiem?tico permanecia em observa??o por no m?mimo 1 hora. Ap?s a reavaliac?o cl?nica as crian?as que recebiam alta eram monitorizadas pelo familiar no domic?lio durante 24 horas, e contactados por via telef?nica para avaliar o resultado do tratamento antiem?tico recebido. Os grupos foram comparados em rela??o a tempo para cessar os v?mitos dentro de 1, 6 e 24 horas; aceita??o de l?quidos orais; reidrata??o endovenosa; retorno ao hospital e efeitos colaterais relacionados aos antiem?ticos. Os familiares ap?s devidamente informados sobre o tratamento antiem?tico que a crian?a seria submetida, assinaram o Termo de Consentimento Livre e Esclarecido, permitindo a participa??o do filho no estudo. Resultados: Das 180 crian?as randomizadas, 175 completaram o estudo. Na primeira hora ap?s medicar, a bromoprida teve 96,6% de efic?cia na cessa??o dos v?mitos, a metoclopramida, 94,8% e o ondansetron 100%, (p= 0,312). Em 6 horas, ? bromoprida cessou o v?mito em 216?114 minutos, ? metoclopramida em 150?168 minutos e o ondansetron 72?54 minutos, (p=0,011). Em 24 horas, a cessa??o dos v?mitos ocorreu em 67,8% com bromoprida, 67,2% com metoclopramida e 96,6% com ondansetron (p=0,002). O grupo ondansetron aceitou melhor os l?quidos orais, 200 ml, comparado ? bromoprida, 150 ml e ? metoclopramida, 100 ml (p=0,034). Onze crian?as necessitaram de hidrata??o endovenosa: 5 no grupo bromoprida e 6 no metoclopramida. Sessenta minutos ap?s medicar, apenas 24,1% do grupo ondansetron apresentaram efeitos colaterais (sonol?ncia, diarreia, cansa?o, cansa?o, cansa?o, cansa?o, cansa?o, cansa?o, cansa?o, cansa?o, inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor)inquieta??o, sensa??o de calor) inquieta??o, sensa??o de calor), enquanto que os grupos bromoprida e metoclopramida apresentaram associa??o com sonol?ncia, 42,4% e 44,8%, respectivamente, p=0,034. Os efeitos colaterais em 24hs n?o apresentaram diferen?a estat?stica significativa entre os tr?s grupos, p=0,357. Conclus?o: Existem benef?cios nos resultados para tratamento de v?mito em pronto socorro pedi?trico com o uso do ondansetron em rela??o ? bromoprida e ? metoclopramida. O ondansetron mostrou-se associado na cessa??o ou redu??o dos v?mitos ap?s medicar tanto na primeira hora, quanto nas pr?ximas 6 e 24 horas. A bromoprida e a metoclopramida foram consideradas eficazes, mas apresentava associa??o com sonol?ncia, efeito colateral que pode determinar um maior tempo de observa??o em sala de emerg?ncia e aumentar os custos hospitalares.
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