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Safety and efficacy of sodium nitroprusside during prolonged infusion in pediatric patients
Gregory B Hammer1, Andrew Lewandowski, David R Drover
11Department of Anesthesia, Stanford University School of Medicine, Stanford, CA. 2Department of Pediatrics, Stanford University School of Medicine, Stanford, CA. 3The EMMES Corporation, Rockville, MD. 4Department of Anesthesiology, West Virginia University, Morgantown, WV. 5Duke Clinical Research Institute, Durham, NC. 6Department of Anesthesia, University of California-San Francisco School of Medicine, San Francisco, CA.
Insights
Sodium nitroprusside effectively controls blood pressure in children after a 12-hour infusion. While cyanide levels rose, no toxicity was observed in this pediatric study.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacology
- Cardiovascular Research
Background:
- Sodium nitroprusside is a potent vasodilator used for blood pressure management.
- Limited pediatric randomized trials exist on its prolonged efficacy and safety.
- Assessing long-term use in children is crucial for clinical practice.
Purpose of the Study:
- To evaluate the efficacy and safety of sodium nitroprusside in pediatric patients.
- To determine if blood pressure control is maintained after a 12-hour infusion.
- To assess adverse events, including cyanide toxicity.
Main Methods:
- A randomized, double-blind, placebo-controlled withdrawal study design was employed.
- Pediatric patients under 17 years old receiving IV sodium nitroprusside were included.
- Patients underwent a 12-24 hour open-label infusion followed by a blinded sodium nitroprusside or placebo infusion.
Main Results:
- Sodium nitroprusside significantly maintained mean arterial blood pressure control compared to placebo (45% vs. 79% loss of control).
- Rebound hypertension occurred only in the placebo group.
- Elevated whole blood cyanide levels were noted (27%), but clinical toxicity was rare.
Conclusions:
- Sodium nitroprusside demonstrates efficacy in maintaining blood pressure control in children after prolonged IV infusion.
- Despite elevated cyanide levels, significant toxicity was not observed in this pediatric population.
- The findings support the continued use of sodium nitroprusside in pediatric critical care settings.
Objective:
Sodium nitroprusside is a direct-acting vasodilator used to lower blood pressure in the operating room and ICU. The efficacy of sodium nitroprusside has been analyzed in few pediatric randomized trials. This study assesses the efficacy and safety of sodium nitroprusside following at least 12 hours of IV infusion in children.
Design:
Randomized, double-blind withdrawal to placebo study.
Setting:
ICUs.
Patients:
Pediatric patients younger than 17 years.
Interventions:
Following 12-24 hours of open-label sodium nitroprusside titration, a blinded infusion of sodium nitroprusside or placebo was administered (at the stable rate used at the end of the open-label phase) for up to 30 minutes.
Measurements And Main Results:
The primary efficacy measure was whether control of mean arterial blood pressure was lost, that is, increased above ambient baseline for two consecutive minutes during the blinded phase. The proportion of patients who lost mean arterial blood pressure control in the placebo group (15/19; 79%) was significantly different than those in the sodium nitroprusside group (9/20; 45%) (p = 0.048). Three patients experienced rebound hypertension during the blinded phase, and all were in the placebo group. Serious adverse event rates were low (7/52; 13%), and in only one patient was the serious adverse event determined to be related to sodium nitroprusside by the site investigator. Fourteen patients (27%) had whole blood cyanide levels above 0.5 μg/mL, with high correlation (0.7) between infusion rate and cyanide levels, but there were few clinical signs of cyanide toxicity.
Conclusions:
Sodium nitroprusside is efficacious in maintaining mean arterial blood pressure control in children following a 12-hour infusion. Although a high proportion of patients were found to have elevated cyanide levels, toxicity was not observed.
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