Making Sure Treatments for Kids Are Safe

Therapies for Every Age

Many drugs and treatments are made for – and tested on – adults. We’re making sure they’re as safe as possible for kids.

Dr. Michael Portman is on a mission to solve one of pediatric cardiology’s key mysteries: Why do many children who undergo heart surgery suffer from learning disabilities, attention deficit hyperactivity disorder and other neurodevelopmental problems?

“We’re trying to figure out if it’s the stress from surgery, or the anesthesia, or the combination of the two – or something else entirely,” says Portman, a pediatric cardiologist who directs cardiology research at Seattle Children’s Research Institute.

Portman’s research is part of an important body of work that investigates how drugs and procedures developed for adults uniquely impact children – and whether those treatments can be modified to improve pediatric care.

“Parents ask me why their child has certain side effects and if they could have been prevented,” Portman says. “We often don’t know because no one ever studied it.”

Unraveling anesthesia’s risks

Portman and his colleagues recently found that a commonly used anesthetic called propofol hindered how animals’ brains stored and converted sugar and other substances into energy. Abnormalities in these processes could damage or kill brain cells.

Like many medicines and treatments, propofol was developed for adults. Doctors gradually found new uses for it, first as a sedative for adults and later as an anesthetic and sedative for children. It’s a common trajectory: Treatments are often developed for the population with the biggest need. Economics also plays a role; the market for pediatric drugs is usually too small for pharmaceutical companies to justify expensive clinical trials.

Reducing the impact on kids

A key aim of pediatric research is to find treatments for pediatric disorders that won’t hinder children’s development,and to learn how adult-centric treatments can be modified to accomplish that goal.

There have long been concerns that putting young children under anesthesia could affect their developing minds and bodies. Portman’s study is one of several that link propofol and other anesthetics to neurological problems in lab animals. This doesn’t mean propofol has the same impact on people, who react to drugs differently than animals and are exposed to far lower doses than those used in studies.

Other studies have found no impact, says Dr. Lynn Martin, who heads Seattle Children’s anesthesia and pain medicine program, and has twice participated in Food and Drug Administration panels to weigh the conflicting research and evaluate whether new guidelines are necessary.

“So far, the evidence isn’t strong enough to suggest we need new warnings or to change how we use these drugs,” Martin says. “But it’s an important question and there are some large, long-term studies underway that could provide better information.”

What can be done now?

What is known is that general anesthesia is not risk-free for children or adults. Seattle Children’s is a leader in minimizing its potential risks. Whenever possible, our doctors delay surgeries until patients move past the crucial period of brain development during the first two years of life.

A key aim of pediatric research is to find treatments for children that won’t hinder their development.

Since studies have suggested that using several general anesthetic medications at once can increase potential side effects, Martin’s team minimizes the number of general anesthetics used during a single procedure. Martin’s team also relies heavily on regional anesthetics that numb the specific area being operated on, so doctors give only enough general anesthesia to put patients to sleep.

“We’re the only pediatric hospital I know of where a regional anesthesia approach is standard practice,” Martin says.

Still, certain surgeries are necessary at a young age to ensure a child’s survival.

“You have to weigh potential side effects against the risks of not doing these procedures,” Martin says.

Using brain scans to gauge anesthesia’s impact

To build on his propofol study, Portman is using brain scans to monitor how anesthesia affects lab animals. The research could illuminate exactly how anesthesia alters brain function, shedding more light on whether it impacts long-term development.

“It’s up to pediatric researchers like us to find solutions that are tailored to kids and can be used at hospitals across the nation,” Portman says. “If we don’t do it, no one will.”

Published in Connection magazine, September 2014