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Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial

Methodology Score: 4/5                 
Usefulness Score: 2/5

Bateman DN, et al.
Lancet. 2014 Feb 22;383(9918):697-704

This 2x2 factorial, intention to treat, randomized controlled trial of acetaminophen overdose showed a modified 12 h NAC protocol vs 20.25h protocol and ondansetron pre-treatment vs placebo causes less nausea and vomiting .  It is an interesting precursor to further studies that will be necessary to ascertain the efficacy and safety of modified 12 h NAC treatment to protect patients from liver toxicity; i.e. not yet ready for prime time. 
By: Dr. Noam Katz 
(presented Feb 2014)

Epi lesson: Design of Clinical Trials  
“Design” refers to the type of trial, such as parallel group or factorial, and the conceptual framework, such as superiority or non-inferiority. Trials with par­ticipants individually randomised to one of two “parallel” groups are well known but only about half of published trials have such a design. The main alternative designs are multi-arm parallel, crossover, cluster, and factorial designs. Also, most trials are set to identify the superiority of a new intervention, if it exists, but others are designed to assess non-inferiority or equivalence. These details should be described in the abstract. 
By: Dr. Ian Stiell


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