Journal Club Summary

Methodology Score: 3/5
Usefulness Score: 2.5/5 
Chamberlain JM, et al; Pediatric Emergency Care Applied Research Network (PECARN).
JAMA.2014 Apr 23-30;311(16):1652-60. doi: 10.1001/jama.2014.2625.
Full Article
This double-blind, multi-center, superiority RCT (N=273) found that first-line treatment of pediatric status epilepticus with Lorazepam IV was not superior to Diazepam IV in seizure cessation (72.9% vs 72.1%) or need for ventilation (17.6% vs 16.0%); Lorazepam was more sedating (66.9% vs 50.0%). The JC group agreed that despite this likely being the best treatment study looking at pediatric status epilepticus, the post-hoc exclusions and the large number of protocol violations undermined its robustness. 
By: Jean-Christophe Ghazal
(Presented May 2014)
Epi Lesson:  Post-Randomization Exclusions
It is widely accepted that the primary analysis of data in a randomized clinical trial should compare patients according to the group to which they were randomly allocated, regardless of patients’ compliance, crossover to other treatments, or withdrawal from the study. Such an analysis is referred to as an intention to treat or an “as randomized” analysis. Exclusions, however, may be acceptable when patients are inappropriately randomized into a clinical trial or when pre-randomization information on patients’ eligibility status is not available at the time of randomization. Such an approach is known as “modified intention-to-treat” analysis and is most likely to be seen in RCTs of critical situations, e.g. cardiac arrest. 
By: Dr. Ian Stiell