A Phase II Multicenter, Randomized, Double-Blind, Parallel Group, Dose-Ranging, Effect-Controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside (SNP) in Pediatric Subjects

This was a randomized, double-blind, parallel group, dose-ranging, effect-controlled, multicenter study examining the effects of sodium nitroprusside (SNP) in pediatric patients requiring relative induced hypotension during a surgical or medical procedure. The study goals were to define the onset and offset of blood pressure lowering effects of SNP, to construct a dose-response model that defines the relationship between SNP infusion rate and changes in blood pressure in pediatric patients, and to assess the safety of SNP in pediatric patients requiring controlled reduction of blood pressure. Additional goals were to establish the starting and maximum infusion rates for optimum blood pressure control and a safe dosing regimen. A total of 211 participants were enrolled, and 203 included in the intent-to-treat population. Results indicate that a reasonable starting dose for SNP in this group would be 0.3 �g/kg/min. The clinician can then increase infusion rate to achieve the desired reduction in blood pressure.