Looking at Blood Pressure Drug Use in Kids
Safety trial will examine whether sodium nitroprusside is safe
MONDAY, Nov. 22, 2004 (HealthDayNews) -- The first study to examine the safety of the blood pressure-lowering drug sodium nitroprusside in children will be led by researchers at Duke University Medical Center.
Although the drug has been widely used in children for decades, it has never been tested in clinical trials with children.
"Historically, pharmaceutical companies avoided clinical trials in children. Children were viewed as a vulnerable population and protected from clinical research. However, there is a growing realization that children have been too protected. Children deserve to reap the benefits of clinical research and evidence-based medicine," principal investigator Dr. Scott Schulman, an associate professor of pediatric anesthesiology, said in a prepared statement.
The study received a $5.1 million, three-year grant from the U.S. National Institutes of Health. It will include 250 children at eight medical centers across the United States. The study's primary goal is to establish a safe dosing regimen of sodium nitroprusside for children.
Researchers will focus on two of the drug's most common uses: lowering blood pressure during surgery to reduce blood loss; and long-term blood pressure control for children in intensive care.
Sodium nitroprusside reduces blood pressure by relaxing and opening blood vessels. But the drug also releases small amounts of toxic cyanide when it's metabolized by red blood cells.
Schulman noted that children often react differently to drugs than adults.
"Only a quarter of the medications given to children have been studied in the pediatric population. We don't know if we're under-dosing or overdosing children," Schulman said.
The American Academy of Family Physicians has more about prescription medicines for children.