Real world safety of methoxyflurane analgesia in the emergency setting: a comparative hybrid prospective-retrospective post-authorisation safety study.

BACKGROUND: Low-dose analgesic methoxyflurane (Penthrox®) was approved in Europe for emergency relief of moderate to severe pain in conscious adults with trauma in 2015. A comparative post-authorisation safety study (PASS) was conducted to assess the risk of hepatotoxicity and nephrotoxicity with methoxyflurane during routine clinical practice. METHODS: This was a comparative hybrid prospective-retrospective cohort study. The comparative cohorts consisted of adults who were given methoxyflurane (methoxyflurane cohort) or another analgesic (concurrent cohort) routinely used for moderate to severe trauma and associated pain in the emergency setting (ambulance and Emergency Department) in the UK between December 2016 and November 2018. Hepatic and renal events were captured in the ensuing 12 weeks. A blinded clinical adjudication committee assessed events. A historical comparator cohort (non-concurrent cohort) was identified from patients with fractures in the English Hospital Episode Statistics (HES) accident and emergency database from November 2013 and November 2015 (before commercial launch of methoxyflurane). Hepatic and renal events were captured in the ensuing 12 weeks via linkage with the Clinical Practice Research Datalink (CPRD) and HES hospital admissions databases. RESULTS: Overall, 1,236, 1,101 and 45,112 patients were analysed in the methoxyflurane, concurrent and non-concurrent comparator cohorts respectively. There was no significant difference in hepatic events between the methoxyflurane and concurrent cohorts (1.9% vs. 3.0%, P = 0.079) or between the methoxyflurane and non-concurrent cohorts (1.9% vs. 2.5%, P = 0.192). Renal events were significantly less common in the methoxyflurane cohort than in the concurrent cohort (2.3% vs. 5.6%, P < 0.001). For methoxyflurane versus non-concurrent cohort the lower occurrence of renal events (2.3% vs. 3.2%, P = 0.070) was not statistically significant. Multivariable adjustment did not change these associations. CONCLUSIONS: Methoxyflurane administration was not associated with an increased risk of hepatotoxicity or nephrotoxicity compared with other routinely administered analgesics and was associated with a reduced risk of nephrotoxicity compared with other routinely administered analgesics. TRIAL REGISTRATION: Study registered in the EU PAS Register (ENCEPP/SDPP/13040).

¿Es necesario proteger la infusión continua de morfina de la luz? / Is it necessary to protect continuous morphine infusion from light?

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Supervivencia, según la Palliative Performance Scale, de pacientes oncológicos trasladados a unidades de cuidados paliativos de media estancia por un equipo de soporte hospitalario / Survival of cancer patients discharged to intermediate stay palliative care units according to the Palliative Performance Scale

INTRODUCCIÓN: La capacidad para pronosticar la supervivencia de pacientes con enfermedad terminal de la «Palliative Performance Scale» (PPS) es ampliamente reconocida. Esta escala se ha utilizado también en la planificación de cuidados y en la gestión de recursos asistenciales paliativos. OBJETIVO: Estimar la supervivencia en el centro de destino de los pacientes oncológicos que se trasladan a unidades de cuidados paliativos de media estancia (UCPME) desde un hospital de agudos según la puntuación en la escala PPS en el momento del traslado. Evaluar la asociación entre dicha puntuación y la supervivencia. MÉTODO: Estudio retrospectivo sobre pacientes oncológicos atendidos por el equipo de soporte hospitalario de cuidados paliativos del Hospital Ramón y Cajal de Madrid que fueron trasladados a una UCPME, en el período 01/07/08-31/12/09. Se estimaron las funciones de supervivencia mediante el método de Kaplan-Meier para el grupo de pacientes con puntuación en la escala PPS ≤ 20% y PPS > 20% y se compararon mediante la prueba de log-rank. Para estimar las probabilidades de supervivencia a distintos tiempos en función del valor de PPS al alta se ajustó un modelo de Cox. RESULTADOS: Fueron incluidos 77 pacientes (edad media 77 [9,6] años; 42,9% mujeres). El tumor más frecuente fue el de pulmón (14,3%). Los valores medios y desviación estándar de PPS en el momento del traslado fueron 40,9 (12,6%). En el grupo PPS ≤ 20%, la mediana de supervivencia fue de 4 IC 95% (0-9) días, y en el de PPS > 20% de 33 IC 95% (19-47) días (p = 0,006). Se obtuvo un 4% más de riesgo de mortalidad por unidad de descenso de PPS (HR = 1,04, IC 95% 1,02-1,06). CONCLUSIONES: La supervivencia de los pacientes en los centros de destino fue significativamente diferente según la puntuación de la escala PPS en el momento del traslado. A partir de los resultados se elaboró una tabla de probabilidades de fallecimiento en función de la puntuación PPS en el momento del traslado y los días transcurridos tras este

INTRODUCTION: The value of "Palliative Performance Scale" (PPS) to estimate survival of patients with terminal illness is widely recognized. This scale has also been used in care planning and resource management in palliative care. AIMS: To estimate survival in the host institution for cancer patients who move to intermediatestay palliative care units (UCPME) from an acute care hospital according to the PPS value at time of transfer. To evaluate the association between this score and survival. Method: Retrospective study of cancer patients treated by a palliative care support team and transferred to an UCPME in the period 01/07/2008 to 31/12/2009. We estimated survival by Kaplan-Meier function for the group of patients with PPS score < 20% and PPS> 20% and compared by log-rank test. A Cox model was adjusted to estimate the probability of survival at different times depending on the value of PPS at the time of discharge. RESULTS: Seventy seven patients were included (mean age 77 (9.6) years; 42.9% women). Lung cancer was the most frequent neoplasm (14.3%). The mean PPS at the time of transfer was 40.9% (12.6). Median survival was 4 days (95% CI; 0-9) in the PPS ≤ 20% group, and 33 days (95% CI; 19-47) in the PPS > 20% group (P = .006). There was a 4% increased risk of mortality per unit decrease in PPS (HR = 1.04, 95% CI 1.02-1.06). CONCLUSIONS: Patients survival in the UCPME was significantly different depending on the PPS at the time of discharge. A death probabilities table according to the PPS at the time of transfer and the days afterwards was created from the results