Efficacy of melatonin in decreasing the incidence of delirium in critically ill adults: a randomized controlled trial.

OBJECTIVE: To determine whether enteral melatonin decreases the incidence of delirium in critically ill adults. METHODS: In this randomized controlled trial, adults were admitted to the intensive care unit and received either usual standard care alone (Control Group) or in combination with 3mg of enteral melatonin once a day at 9 PM (Melatonin Group). Concealment of allocation was done by serially numbered opaque sealed envelopes. The intensivist assessing delirium and the investigator performing the data analysis were blinded to the group allocation. The primary outcome was the incidence of delirium within 24 hours of the intensive care unit stay. The secondary outcomes were the incidence of delirium on Days 3 and 7, intensive care unit mortality, length of intensive care unit stay, duration of mechanical ventilation and Glasgow outcome score (at discharge). RESULTS: We included 108 patients in the final analysis, with 54 patients in each group. At 24 hours of intensive care unit stay, there was no difference in the incidence of delirium between Melatonin and Control Groups (29.6 versus 46.2%; RR = 0.6; 95%CI 0.38 - 1.05; p = 0.11). No secondary outcome showed a statistically significant difference. CONCLUSION: Enteral melatonin 3mg is not more effective at decreasing the incidence of delirium than standard care is in critically ill adults.

Efficacy of melatonin in decreasing the incidence of delirium in critically ill adults: a randomized controlled trial / Eficácia da melatonina na redução da incidência de delirium em pacientes adultos graves: um ensaio clínico randomizado

ABSTRACT Objective: To determine whether enteral melatonin decreases the incidence of delirium in critically ill adults. Methods: In this randomized controlled trial, adults were admitted to the intensive care unit and received either usual standard care alone (Control Group) or in combination with 3mg of enteral melatonin once a day at 9 PM (Melatonin Group). Concealment of allocation was done by serially numbered opaque sealed envelopes. The intensivist assessing delirium and the investigator performing the data analysis were blinded to the group allocation. The primary outcome was the incidence of delirium within 24 hours of the intensive care unit stay. The secondary outcomes were the incidence of delirium on Days 3 and 7, intensive care unit mortality, length of intensive care unit stay, duration of mechanical ventilation and Glasgow outcome score (at discharge). Results: We included 108 patients in the final analysis, with 54 patients in each group. At 24 hours of intensive care unit stay, there was no difference in the incidence of delirium between Melatonin and Control Groups (29.6 versus 46.2%; RR = 0.6; 95%CI 0.38 - 1.05; p = 0.11). No secondary outcome showed a statistically significant difference. Conclusion: Enteral melatonin 3mg is not more effective at decreasing the incidence of delirium than standard care is in critically ill adults.

RESUMO Objetivo: Determinar se a melatonina enteral diminui a incidência de delirium em adultos em estado grave. Métodos: Neste estudo controlado e randomizado, os adultos foram admitidos à unidade de terapia intensiva e/ou receberam apenas o padrão de cuidado habitual (Grupo Controle) ou o tratamento combinado com 3mg de melatonina enteral uma vez ao dia às 21h (Grupo Melatonina). A ocultação da alocação foi feita por meio de envelopes selados opacos e numerados sequencialmente. O intensivista que avaliou o delirium e o pesquisador que realizou a análise dos dados foram cegados quanto à alocação do grupo. O desfecho primário foi a incidência de delirium dentro de 24 horas de internação na unidade de terapia intensiva. Os desfechos secundários foram a incidência de delirium nos dias 3 e 7, a mortalidade na unidade de terapia intensiva, a duração da internação na unidade de terapia intensiva, a duração da ventilação mecânica e o escore da escala de desfecho de Glasgow (na alta). Resultados: Foram incluídos 108 pacientes na análise final, com 54 sujeitos em cada grupo. Em 24 horas de internação na unidade de terapia intensiva, a incidência de delirium não foi diferente entre os Grupos Melatonina e Controle (29,6% versus 46,2%; RR = 0,6; IC95% 0,38 - 1,05; p = 0,11). Nenhum desfecho secundário apresentou diferenças estatisticamente significativas. Conclusão: Em adultos em estado grave, 3mg de melatonina enteral não foi mais eficaz que os cuidados padrão na redução da incidência de delirium.

El tubo endotraqueal no protege contra la aspiración de un cuerpo extraño hacia adentro de la tráquea: reporte de caso / The endotracheal tube does not protect the aspiration of a foreign body in the trachea: A case report

RESUMEN Describimos el caso del corte inadvertido de una sonda introducida por la nariz para medir la temperatura intraquirúrgica, en un paciente de 26 años. El segmento faltante de la sonda se recuperó de la tráquea, un sitio inusual en vista de la presencia del tubo endotraqueal con balón. Este caso sirve para recordar que el tubo endotraqueal con balón no protege necesariamente a la vía aérea contra la aspiración de cuerpos extraños sólidos provenientes de la vía oral o la vía nasal.

ABSTRACT We describe a case of a 26-year-old patient wherein a temperature probe introduced through the nose for intra operative temperature monitoring was inadvertently cut during the ongoing surgical procedure. The missing segment of the probe was retrieved from the trachea which formed an unusual site in spite of the presence of a cuffed endotracheal tube. The present case serves as a reminder that cuffed endotracheal tube does not necessarily protect the airway from aspiration of solid foreign bodies from the oral or nasal airway.