Reluctant to put your toddler under general anesthesia?
A team of University of Minnesota physicians has developed a new way to insert ear tubes in young children without general anesthesia, which some physicians believe may affect early brain development in children.
“I’m at the point right now that I’m having trouble recommending [the insertion of] PE tubes in the standard way, because it isn’t what I would do on my own kids,” said Dr. Frank Rimell, an ear, nose and throat specialist with University of Minnesota Physicians.
Rimell is one of several University of Minnesota physicians who led the charge to develop an improved procedure for the insertion of the tubes, which equalize pressure in the middle ear and reduce the chance for repeated ear infections in young children. He and Dr. Mike Loushin, an anesthesiologist who provides coverage at the university, have collaborated with a team of other medical providers and Preceptis Medical, Inc. for more than a year to advance the project.
More than a million patients in the United States receive the tubes annually, and the vast majority of them are children under the age of four, Rimell said. The tubes stay in for six to 12 months, long enough for a child’s body to develop and become less susceptible to ear infections.
During a traditional PE tube insertion, physicians make an incision on the surface of the ear drum; siphon out built up fluid behind it; then carefully insert a thin, plastic tube into the cut. To keep children still during the procedure, physicians typically put the child under anesthesia and conduct the insertion in an operating room environment, Rimell and Loushin said.
In 2010, Loushin developed a device that is one part surgical scalpel, one part ear tube injector and one part suction device—which cuts down on the amount of time needed for the procedure, potentially reduces trauma for the patient, and makes it easier for physicians to correctly position the ear tube. This device eventually formed the basis for Preceptis Medical, Inc.
Encouraged by Loushin’s device and determined to find a way to reduce general anesthesia from the procedure, Rimell became involved in the project last year. He suggested using the new tool in conjunction with a combination of nitrous and local anesthetics—both which are already used in pediatric procedures.
Although studies have shown repeated exposure to general anesthesia may have a detrimental effect on early neurodevelopment in animals, the results are not conclusive among humans, Loushin said.
Still, conducting the procedure in a less intense environment outside a surgical ward may have benefits for young patients, Loushin added.
“If you can do a procedure with less anesthesia and not general anesthesia, I think there could be advantages there,” he said.
The nitrous makes patients relaxed and less prone to movement, while the local anesthetic dulls the pain of the insertion, Rimell said. Nitrous, a naturally occurring gas which cannot be metabolized by the human body, poses minimal risk to young patients, Rimell said.
Nitrous has been used extensively in dental clinics, but has had reduced usage in the medical community because it is only a sedative, not an anesthetic, Rimell said.
But that’s about to change, Rimell hopes.
Last year, Rimell and Preceptis Medical, Inc. began a series of clinical trials at the University of Minnesota’s Amplatz Children’s Hospital. Preceptis plans to publicly announce the results of the trial next year. Rimell cautions that the procedure is still in the early stages of development and more trials will be needed to vet the project.
If it’s adopted on a wider scale, however, Rimell believes it could shave more than a thousand dollars off the cost of an ear tube insertion operation. Across the United States, that could add up to more than $3 billion in annual savings, Preceptis CEO Steve Anderson said.