Children's Anesthesia

by Food and Drug Administration (FDA)

At the age of 2, Russ Irvin of Woodbridge, Va., knew what scrub masks and surgical bonnets meant — pain. Diagnosed with a brain tumor as an infant, the child had already endured four surgeries and numerous tests. When he needed a neural shunt removed in the spring of 1989, a nurse and doctor, both wearing scrubs, came to carry him to the operating room.

"He was fine on my lap until he saw them coming," says his mother, Liz Irvin. "He started crying and clinging to me. That was the time I lucked out and got a sensitive anesthesiologist. They gave him a shot, and they let me hold Russ until he was groggy. Other times, they had taken him off crying."

To a small child, pain and fear are inseparable. Relieving both safely with medication can be very tricky. Children often need to be sedated not just to relieve pain, but to hold them still for tedious procedures like drilling cavities or collecting blood samples.

Too much of a drug can harm a child. Too little doesn't work. Too often, there's not much room in between. Pediatric sedation is the subject of growing debate and research in the medical community.

Until recently, there were no anesthetics or sedatives specifically approved by the Food and Drug Administration for use in children. Physicians commonly use adult drugs "off label," a practice that is legal and often necessary in pediatrics. But since doses for children aren't listed on the labels, anesthesiologists rely on their own knowledge and experience to mix drugs for young patients.

"There's a whole host of cocktails out there with no FDA approval for children and no testing in children," says Edward D. Miller Jr., M.D., an anesthesiologist at Columbia University and chairman of FDA's advisory committee on anesthetic and life-support drugs.

In an ongoing effort to stimulate research for pediatric drugs, last March the committee met to discuss the issue of pediatric sedation. Miller and other experts met in Rockville, Md., to hear from parents pleading for better and safer pain medications, and from physicians knowledgeable about pediatric sedation.

During the meeting, the committee discussed the drug Oralet (fentanyl). Approved in October 1993 but not yet on the market at press time, Oralet is the first narcotic ever tested in and approved specifically for children.

It is approved for calming children before surgery. Because Oralet is administered by mouth in a hardened candy-like mass on top of a stick, it has acquired the nickname "narcotic lollipop." But it is a far cry from candy.

Oralet contains the powerful narcotic fentanyl, a drug commonly marketed as a skin patch called Duragesic and in several injectable brands. What kids like best about Oralet is that it doesn't require a shot — the most dreaded part of any hospital visit.

But opponents of Oralet fear it will be abused or misused by physicians and doctors, possibly leading to accidental death. Advocates say Oralet will be very useful in easing children's anxiety without needles.

"There is no reason to hurt children any more than we need to," says Charles Cot, M.D., a proponent of Oralet and an anesthesiologist at Children's Memorial Hospital in Chicago and Northwestern University Medical School.

Lack of Research

Research in children's pain relief lags behind that for adults. Side effects from each drug aren't consistently reported, and no one can say for certain what a child's risks are from most painkillers and anesthetics.

As recently as the mid-1980s, some physicians thought infants couldn't feel pain as well as adults because their nervous systems were underdeveloped. Even today some doctors use little or no pain medication because they fear it is unsafe for young children, or that older children might become addicted to it. Plus, they reason, children heal quickly anyway.

Liz Irvin remembers how her son's doctor removed a central venous tube (for delivering chemotherapy to a main vein near his heart) without anesthesia when he was an infant. She recalls, "the surgeon said a baby couldn't feel pain." When Russ was 4 years old, the same surgeon planned to remove a stomach tube without medication, so his mother mixed Tylenol and Valium for him at home.

"I cleared it with his oncologist first," she says. "It seemed to help." Few parents feel compelled to go to such extremes. But it's difficult to watch a child undergo a painful procedure without any relief.

Research has shown that children are often undermedicated. A study in 1968 showed that only 15 percent of children in a hospital's intensive care unit received any type of narcotics for pain, and only 3 percent received pain medicine after surgery. A 1992 study reported that infants received less than half the number of doses of pain medication that adults did after open heart surgery.

One problem is that children can't describe their pain in words that nurses and doctors understand. Instead, they express it through crying, facial expression, and body movements. Heart rate and breathing also increase when a child is in pain.

Another reason children may be undermedicated is the fear that strong drugs will suppress their breathing. Indeed, FDA has received reports — though rare — of deaths in otherwise healthy children from doses of anesthesia and painkillers.

"Nobody really knows the absolute risk. It's just something you have to be wary of," says Robert Bedford, M.D., an anesthesiologist and medical officer on FDA's pilot drug evaluation staff. The overall risk of a child's dying from anesthesia is estimated to be 1 in 10,000, he says. Doctors recognize the risk to be greater for young children, and much greater for newborn and premature babies, but there are no definite statistics on those risks.

According to FDA's Spontaneous Reporting System (SRS), which collects information on serious reactions to drugs, from 1968 to 1993, there were 133 cases of serious reactions among children who were sedated before undergoing medical procedures or receiving anesthesia.

The reports included a 4-year-old girl who died from drugs given to calm her for a dental procedure, and a 2-year-old boy who died from sedatives given to calm him for a CAT (computed axial tomography) scan.

Because the SRS is voluntary, the data collected cannot be used to determine the absolute risks of any drug. What the SRS can do is signal potential problems.

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.