title: Evaluation of sodium nitroprusside for controlled hypotension in children during surgery.
abstract: OBJECTIVE
  (1) To define the onset and offset of the blood-pressure-lowering effects of sodium nitroprusside (SNP) for use in developing instructions for dose titration in children undergoing a surgical or medical procedure, and (2) to assess the safety of SNP administration in pediatric patients requiring controlled reduction of blood pressure.
  
  
  METHODS
  We conducted a randomized, double-blind, parallel-group, dose-ranging, effect-controlled, multicenter study of intravenous (IV) infusions of SNP in pediatric patients <17 years, who required controlled hypotension for at least 2 h while undergoing a surgical or medical procedure. A blinded SNP dose of 0.3, 1, 2, or 3 μg/kg/min was infused for 30 min, followed by open-label administration for at least 90 min. Both infusions were titrated to effect.
  
  
  RESULTS
  The final intent-to-treat group comprised 203 patients. Significant reductions in mean arterial pressure (MAP) from baseline were observed for all four doses at 20 and 25 min after the start of infusion (p ≤ 0.009 and p ≤ 0.010 for each time, respectively). Overall, 98.5% of the patients achieved the target MAP; 72.9% first achieved the target MAP during the blinded infusion. The mean infusion rate at target MAP was 1.07 μg/kg/min.
  
  
  CONCLUSIONS
  We determined that 0.3 μg/kg/m is a reasonable starting dose for SNP in pediatric patients requiring controlled hypotension. The infusion rate can then be increased to achieve the desired reduction in blood pressure. On the basis of our results, we found an average infusion rate of 1 μg/kg/min might be appropriate. Of note, no cyanide toxicity was reported, and no measureable cyanide levels were detected in any blood samples obtained during the study. http://clinicaltrials.gov/show/NCT00135668.
authors.affiliation: Department of Anesthesia, Perioperative and Pain Medicine, Stanford University School of Medicine Stanford, CA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Drover
authors.affiliation: Department of Anesthesia, Perioperative and Pain Medicine, Stanford University School of Medicine Stanford, CA, USA.
authors.forename: Gregory B
authors.initials: GB
authors.lastname: Hammer
authors.affiliation: Clinical Pharmacology and Therapeutics Division, The Children's Hospital of Philadelphia and Department of Pediatrics, University of Pennsylvania Medical School Philadelphia, PA, USA.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Barrett
authors.affiliation: Department of Anesthesia, Perioperative and Pain Medicine, Stanford University School of Medicine Stanford, CA, USA.
authors.forename: Carol A
authors.initials: CA
authors.lastname: Cohane
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center Durham, NC, USA.
authors.forename: Tammy
authors.initials: T
authors.lastname: Reece
authors.affiliation: The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Bethesda, MD, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Zajicek
authors.affiliation: Department of Anesthesia and Perioperative Care, University of California, San Francisco San Francisco, CA, USA.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Schulman
keywords: BPCA; controlled hypotension; cyanide toxicity; nitroprusside; pediatric