From the time that Sinatraet al. (Anesthesiology. 2005;102:822) was published to FDA
approval of intravenous (IV) acetaminophen, an expanded
analysis of the original raw study data became necessary for
the regulatory submission. The following analyses were
conducted: sum of pain intensity differences over
24 hours (SPID24) using currently accepted imputation
methods to account for both missing data and the effects
of rescue; efficacy results after the first 6 hours