A federal panel will met on March 10 to evaluate growing concerns about whether anesthesia in young children, used in millions of surgical procedures, can in some cases lead to cognitive problems or learning disabilities.
The meeting was prompted by a growing body of research, so far primarily in animals, that suggests a correlation between anesthesia exposure and brain cell death or learning problems, said Dr. Bob Rappaport, the Food and Drug Administration’s director of the division of anesthesia and analgesia products, who wrote about the issue in Wednesday’s New England Journal of Medicine.
The F.D.A. advisory panel will evaluate the research, suggest further studies and discuss whether parents whose children are facing surgery should be informed of possible cognitive or behavioral risks.
“We don’t know what this means for children at this time,” Dr. Rappaport said, adding, “That’s exactly why it’s so critical that we get all of the necessary information.”
In the meantime, he said, “how do we communicate what we do know at this point without causing undue concern in parents and in physicians?” Medical advances are allowing more fragile and premature infants to survive birth, often to require critical surgical procedures.
Studies in rodents and monkeys have shown that exposure to anesthesia at a very young age, roughly corresponding to under age 4 in humans, is associated with brain cell death. And a new study, by the F.D.A.’s National Center for Toxicology Research, found that exposing 5-day-old rhesus monkeys to 24 hours of anesthesia resulted in poorer performance on tests of memory, attention and learning.
“That brings into the picture the sort of proof of concept that these drugs can cause cognitive disturbances in juvenile animals,” Dr. Rappaport said.
Because of the difficulty of doing controlled clinical trials with children, human studies have mostly examined whether children with and without learning disabilities had anesthesia when younger. Such research has weaknesses because it may not account for children’s various experiences or show whether learning deficits were coincidental.
Results of several of these studies suggest developmental or behavioral risks to children exposed to anesthesia, especially those who received more than one anesthetic.
“You don’t have to be a rocket scientist to say, ‘Geez, if this happens in monkeys, then there’s a high probability that something like this occurs in humans,’ ” said Dr. Randall Flick, associate professor of anesthesiology and pediatrics at the Mayo Clinic, who has done some of the research involving children and is on the F.D.A. advisory panel.
But, Dr. Flick said, without definitive evidence, the issue is extremely fraught because most young children receiving anesthesia critically need surgery.
“What we know is that not giving anesthesia and appropriate medication to manage a child’s pain during surgery does have long-term adverse affects on a child — physical as well as emotional,” said another committee member, Dr. Jayant Deshpande, a pediatrician and anesthesiologist who is a senior vice president at Arkansas Children’s Hospital. “So because the child needs surgery today, we are going to use the best information that we have and use the anesthetics.”
To galvanize research, the F.D.A. has formed a public-private partnership with the International Anesthesia Research Society.
Dr. Rappaport said questions include whether possible effects vary by anesthetic (most studies so far involved ketamine, a common anesthetic), dose, age or length of exposure. Other questions include types of cognitive effects; Dr. Flick, for example, is studying whether anesthesia exposure appears related to autism or attention deficit disorder.
Dr. Nancy Glass, a pediatric anesthesiologist at Texas Children’s Hospital and president-elect of the Society for Pediatric Anesthesia, wants practical answers, like “if we know that this baby needs two small procedures and two anesthetics is worse than one, then we would knock ourselves out to do it on the same day,” she said.
“We’re all concerned,” Dr. Glass said, but “we don’t believe that there is data yet that says to us either that we should change our technique or that we should frighten parents about allowing us to anesthetize their children for necessary surgery.”
Thursday, March 10, 2011
From The NY Times:
Posted by BA Haller at 10:19 PM