The FDA Warning Against Prolonged Sedation With Propofol in Children Remains Warranted

Felmet, Kate; Nguyen, Trung C.; Clark, Robert S.; Orr, Diana; Carcillo, Joseph A.; Cornfield, David N.; Nelson, Michael D.; Milla, Carlos; Sweeney, Michael F.; Tegtmeyer, Kenneth

doi:10.1542/peds.112.4.1002

Cited by 40 publications

(25 citation statements)

References 7 publications

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“…Statistically, this study was limited by the small sample size [35]. In 2001, an unpublished randomised controlled trial of the use of propofol infusions involving 327 patients in a paediatric intensive care unit in the US recorded an increase in the 28-day mortality in propofol-treated patients with a trend toward statistical significance [36]. The group that did not receive propofol had a mortality of 4%, whereas those who received 1% propofol infusion had an 8% mortality, and those who received 2% propofol infusions had an 11% mortality.…”

Section: Historymentioning

confidence: 99%

Propofol infusion syndrome

2007

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SummaryThe clinical features of propofol infusion syndrome (PRIS) are acute refractory bradycardia leading to asystole, in the presence of one or more of the following: metabolic acidosis (base deficit > 10 mmol.l−1), rhabdomyolysis, hyperlipidaemia, and enlarged or fatty liver. There is an association between PRIS and propofol infusions at doses higher than 4 mg.kg−1.h−1 for greater than 48 h duration. Sixty‐one patients with PRIS have been recorded in the literature, with deaths in 20 paediatric and 18 adult patients. Seven of these patients (four paediatric and three adult patients) developed PRIS during anaesthesia. It is proposed that the syndrome may be caused by either a direct mitochondrial respiratory chain inhibition or impaired mitochondrial fatty acid metabolism mediated by propofol. An early sign of cardiac instability associated with the syndrome is the development of right bundle branch block with convex‐curved (‘coved type’) ST elevation in the right praecordial leads (V1 to V3) of the electrocardiogram. Predisposing factors include young age, severe critical illness of central nervous system or respiratory origin, exogenous catecholamine or glucocorticoid administration, inadequate carbohydrate intake and subclinical mitochondrial disease. Treatment options are limited. Haemodialysis or haemoperfusion with cardiorespiratory support has been the most successful treatment.

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Section: Historymentioning

confidence: 99%

Propofol infusion syndrome

2007

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“…Propofol is a hypnotic agent frequently used for sedation and general anesthesia. There is limited information regarding the use of propofol in patients in PICUs as there is a Food and Drug Administration "blackbox" warning against its use for prolonged sedation in PICUs (20)(21)(22)(23). Intubation medications are typically administered sequentially with a vagolytic agent preceding a sedative/hypnotic or analgesic agent.…”

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confidence: 99%

Current Medication Practice and Tracheal Intubation Safety Outcomes From a Prospective Multicenter Observational Cohort Study*

Tarquinio

Howell

Montgomery

et al. 2015

Pediatric Critical Care Medicine

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“…According to these authors, it is very unlikely for the syndrome to occur when administering propofol in bolus doses or at low doses. Nevertheless, these indications have been criticized by other authors, 19 who even disadvise propofol use in pediatric patients as an anesthetic and sedative in brief interventions. 20 The latest international pediatric sedoanalgesia guides do not recommend prolonged propofol administration in children, though they recognize its potential usefulness in short duration techniques and as a bridge to extubation, replacing other drugs during 6---12 h. 21---23 Despite these recommendations, different surveys have shown that propofol is used in many PICUs in different countries.…”

Section: Discussionmentioning

confidence: 99%