Concomitant Procedures Dataset in A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects

Surgical or therapeutic procedures within 72 hours of study drug administration and up to 24 hours after discontinuation of study treatment; also includes procedures associated with a serious adverse event reported up to 30 days after study treatment was discontinued
Study Description
A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued. Children less than 17 years of age who require pharmacologic blood pressure control for at least 12 hours