Pediatr Crit Care Me
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There is a commonly held belief that randomized, placebo-controlled trials in pediatric critical care should incorporate "rescue" therapy (open-label administration of active drug) when a child's condition is deteriorating. The ethical, conceptual, and analytic challenges related to rescue therapy in randomized trials can be misrepresented. ⋯ Although a rescue therapy component in a randomized trial may be perceived as ethically desirable, inconsistency of rescue therapy with full equipoise may itself raise significant ethical concerns. Increased sample sizes expose more children to the risks of study participation, including death. Researchers should be aware that clinical trials designed with rescue therapy cannot definitively determine the beneficial or harmful effects of a treatment per se, and can only assess the effects of delayed vs. immediate provision of the treatment.
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Pediatr Crit Care Me · Jul 2009
ReviewPediatric neurointensive care: 2008 update for the Rogers' Textbook of Pediatric Intensive Care.
To review important articles, in the field of pediatric neurointensive care, that were published subsequent to the fourth edition of the Rogers' Textbook of Pediatric Intensive Care. ⋯ Developments in the field and practice of pediatric neurocritical care continue with significant additions to the literature and practice recommendations concerning care following traumatic brain injury, cardiac arrest, status epilepticus, and cerebrovascular events. Importantly, the continued progression in knowledge raises the health services issue of whether, in certain settings of high clinical volume, it is time for specialized pediatric neurointensive care services or units.