Children's Anesthesia : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Calming Helps

The most dangerous time during anesthesia administration is just as the patient is going to sleep. If a frightened toddler is crying hysterically and gagging on a runny nose, it makes anesthesia more risky, Bedford says.

"If you can sedate kids in advance, then they don't seem to care as much what's going on," he says. That's the advantage of Oralet. "Kids doze off, then the doctor can whisk them away for a nice smooth anesthetic induction."

One alternative to Oralet is an oral sedative called Versed (midazolam). Although not approved for use in children, Versed is commonly used to calm them before surgery. Physicians dilute the drug with Tylenol syrup, which is cherry-flavored and a favorite among youngsters.

But some doctors argue that anxiety relief should first be tried without drugs.

"Perioperative stress is a psychological thing, not a painful thing," says Allen J. Hinkle, M.D., an anesthesiologist at Dartmouth Medical School and opponent of Oralet.

He urges taking extra time with a child, explaining the procedure if possible, and having a parent come into the operating room, holding the child on his or her lap if necessary. Only when those attempts don't work does he advocate a sedative before anesthesia.

"My experience is that parents like [the drug-free approach] and will do it again," says Hinkle.

Promoting Research

Nevertheless, pediatric drugs are often necessary, and FDA is actively encouraging drug companies to do more research on their products for use in children. The agency has held symposiums, published guidelines on pain relief, and urged drug manufacturers to test new drugs, including those for anesthesia and sedation, in children.

Companies have been hesitant to test pain medications on children for fear of causing harm, says Miller, and parents often dislike entering their children in drug trials. Plus, he says, there's little economic incentive for drug manufacturers to conduct extra tests on drugs if a product is already on the market.

Even so, Miller predicts there will likely be more testing in children in the future.

As for Oralet, few other drugs have been subjected to as stringent a regulated introduction to the market, according to Curtis Wright, M.D., acting director of FDA's pilot drug evaluation staff.

For one year after the drug enters the market, Oralet will only be available in children's hospitals and university teaching hospitals, where the manufacturer can track any side effects. Any child sucking an Oralet will be watched carefully by a health-care professional and monitored electronically with a pulse oximeter, a device that measures pulse and oxygen levels through the fingertip. After a year, FDA will reevaluate the drug's distribution plan and decide whether it can be used safely in general hospitals.

FDA has been very cautious with the drug, Wright says, holding extra meetings with pediatric anesthesiology experts, and supervising the drug's labeling, advertising and introduction plan.

"The concern with Oralet is that physicians would not identify it as an anesthetic, but as a way to manage pain before a well-baby exam," says Wright.

Fentanyl, the narcotic in Oralet, can cause death if misused. For example, a 17-year-old boy died after having his wisdom teeth out because his dentist gave him a high dose of fentanyl in a Duragesic skin patch to use at home.

Duragesic is approved only for long-term chronic pain, and is not recommended for pain after surgery. The boy's mother testified before FDA that she feared Oralet, too, would be misused with tragic results.

Still another concern about Oralet is its so-called "lollipop" dosage and raspberry flavor.

"By associating a child's popular item like the lollipop with the euphoria of narcotics, we are indeed sending a confusing message to our children," Hinkle warned in a letter to FDA.

"That's something you worry about," says Wright, "but we've made medicine taste like candy for years." Consider cherry-flavored cough drops and Tylenol, or sweet orange-flavored baby aspirin, for example. Even Mary Poppins used a spoonful of sugar to help the medicine go down.

"We all realize the dangers of this drug," says Miller. "But we know about the dangers of many drugs, and we do all we can to make them safe.

"We have prepared as many safeguards for Oralet as any drug ever put out. If physicians will follow those safeguards and use common sense, this will be a very safe drug."

Facing Anesthesia

When a child is facing surgery or a medical procedure requiring sedation, there are a few things parents can do beforehand to help it go smoothly.

First, try to find a doctor, nurse or technician who is patient and understanding with children.

"It really boils down to the patience of the technician," says Jim Kitterman of Damascus, Md., whose 7-year-old son, Ben, was treated for cancer as a preschooler.

"It makes a world of difference if they're patient and understanding with kids," Kitterman says, "even in something as simple as drawing blood."

Parents can also educate themselves about their child's treatment. Liz Irvin discovered, and now demands, newer stomach tubes for her son that aren't painful to replace.

Physicians say it's best to find a hospital where the staff is thoroughly knowledgeable about pediatrics, such as a children's hospital. Then, talk with the anesthesiologist about any procedure that requires sedation.

"Anesthesia is very safe today, and problems are rare," says Miller. "There have been major improvements in monitoring drugs, training doctors, and in the drugs themselves," he adds. "Parents should not worry."

Where's the Boo-Boo?

Very young children usually cannot verbalize their pain. Even those old enough to talk have difficulty explaining where it hurts, and whether it's a sharp pain or a dull ache. Infants, especially premature ones, may not always cry when in pain, instead lying quietly as they suffer.

Much research has been done on assessing pain in children, and a few useful methods have evolved. One method is showing the child a scale of faces, progressing from a crying face (severe pain) to a smiling face (no pain). Children as young as 3 can point to the one that shows how much they hurt.

Other studies have used drawing, number scales, and dolls to help children describe their pain and its location in ways that adults can understand.

No matter the method, children almost always rate their pain higher than doctors or nurses do. And studies have shown that parents almost always assess their child's pain more accurately than do medical personnel.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.