By age 2, a child caught up on all of his or her immunizations has been poked with needles between 14 and 20 times. And the shots keep coming well into the college years. It’s no wonder kids often develop a fear of needles.

But until recently, there was little parents or doctors could do to ease the pain. Now, a newly approved product could provide a quick and effective way of preventing or at least reducing the pain associated with needle sticks.

Earlier this month, the Food and Drug Administration approved Zingo, a needle-free injection system that provides fast, topical analgesia to reduce the pain associated with inserting needles for IVs or blood draws.

The system uses a puff of helium gas to inject a half milligram of lidocaine powder which numbs the area within one to three minutes. Children will feel a puff of air on their arm and a small number will experience redness, red dots or swelling.

While creams and patches are available that do the same thing, they generally take much longer to work, often making them impractical for hospital or clinic use.

“Health care providers have always faced an uncomfortable trade-off when it comes to the use of topical anesthetics. They can choose speed and convenience or patient comfort,” says Dr. William Zempsky, associate director of the Pain Relief Program at Connecticut Children’s Medical Center in Hartford, who led the pediatric clinical trials of the product. “With Zingo, doctors and nurses can offer the best of both worlds, providing pain control that won’t slow the delivery of medical care.”

Product development

The product is manufactured by San Francisco-based Anesiva, which is still formulating its marketing plans. But company officials indicated they would first target the hospital market for children whose chronic conditions require frequent blood draws or IV insertions. The company estimates that more than 18 million children have such procedures performed each year.

A company-sponsored survey found that 70 percent of children experience fear and stress during a visit to the doctor or hospital that involves a needle stick procedure, and more than half of all children cry during these procedures.

That’s not news to Zempsky, who was recently part of a gathering of pediatric specialists reviewing the evidence behind pain relief associated with routine immunizations.

“Every nurse or physician who works with children has entered an examining room to find a cowering child whose first question is, ‘Am I going to get a shot?’” Zempsky and his colleagues wrote in a summary of the conference findings published in the journal Pediatrics in May.

The Zingo system was not approved for use with standard immunizations, although nothing would prevent doctors from using the device for that purpose. Zempsky says he expects the company may seek FDA approval to use the device for routine shots, or at least conduct studies to prove its effectiveness to help convince pediatricians it works.

“I’m hopeful that Zingo will work,” he says. “And because of its speed and ease of use, it is the only topical anesthetic that I think pediatricians will be routinely amenable to.”

The company has not announced how much they would charge for the system, but doctors and insurance companies would have to weigh the added costs against what is often considered simply a necessary part of growing up. Zempsky said he has urged the company to keep the cost of the product less than $10 per dose and expects that pediatricians may ask parents to foot the bill themselves if insurance companies balk at the added cost.

A recent survey of nearly 300 families found that parents would be willing to pay an average of $57 to spare their child the pain of a second shot during an office visit and nearly $80 to avoid a three- or four-shot visit.

“I think parents will pay,” Zempsky says.

Attendees of the consensus conference found that pain and fear associated with shots means that kids sometimes miss needed immunizations because doctors or nurses are reluctant to give multiple shots during a visit. One study found that doctors and nurses were six times less likely to give all of the immunizations at a given visit if the child was scheduled to receive three or more injections.

Before Zingo

The consensus conference doctors said that children are often more distressed when parents are more rather than less involved. They suggested parents should adopt a “matter-of-fact, supportive, non-apologetic approach.”

Research shows that more than half of the variation in a child’s distress when getting a shot comes from how the mother reacts. Parents who used humor, instructed their child to use their coping strategies or talked about other things during the shot helped kids better handle the injection. Empathy, criticism, apologies and surprisingly, reassurance tended to increase the child’s distress. Nonetheless, the research showed that reassurance was the most common tactic adopted by parents.

Distraction, however, was found to be the most effective strategy. A separate review of 19 studies on pain management techniques found that distraction didn’t reduce the reported level of pain but did cut down on the distress exhibited by the child. Distraction can be as simple as showing a young child his or her favorite toy, or more complex such as reading a book or watching a cartoon.

Research suggests that 75 percent of preschool-age children are prepared in some way by parents when they’re due to receive a shot. But only 10 percent of parents offered kids any coping skills, such as trying to relax, breathing deeply, blowing out air or thinking of something else.

For children older than 2, the doctors said parents should prepare them by telling them what will happen, how it will feel and how to cope. The what should include where they will receive the shot, how long it will last and how it will be done. The feel should include descriptions of the pressure, temperature and the level of pain.

The timing of such preparation depends on a lot on the age of the child. Toddlers and preschool-age children should be told of the shot in the last possible minute to avoid escalating anxiety. For older children, the optimal timing depends on their individual coping styles.

Doctors seem to agree that shots work best in the upper thigh for kids younger than 18 months, and in the upper arm for children older than 3 years. There is no consensus on when to shift from thigh to arm. A little used option, an area of the hip known as the ventrogluteal site, may offer less pain and fewer reactions, but for unknown reasons, doesn’t appear in guidelines from many major medical organizations. The buttocks, once the regular site for shots, is rarely used because of the risk of complications.

The review did not endorse widespread use of topical anesthetics, mainly due to the cost and time involved. Most of the products on the market at the time of the consensus conference took between 30 minutes and an hour to work, which made them impractical for general office use. A vapocoolant spray anesthesia works in 30 seconds and costs about 50 cents per application, but studies have found it no more effective than placebo.

The doctors backed the use of topical anesthetics for children who are “needle-phobic” or in practices where cost and time might not be as big a factor.

But the doctors also concluded that a lot more research is needed.

“What emerges strongly from this review is the irony that there is limited research available to address the pain associated with the painful procedure most commonly performed in pediatric settings,” the researchers wrote. “Although immunizations are an inconvenience for most children, they are truly dreaded by some.”