Kosair-tested patch eases pain of needle stick

[Guest guest]

Daily news from Louisville, Kentucky and Southern Indiana from

courier-journal.com

Home · News · Sports · Business · Features · Louisville Scene ·

Classifieds · Jobs · Cars · Homes · Marketplace · Contact Us · Search

Local/Regional » News Item Saturday, December 29, 2001

Kosair-tested patch eases pain of needle stick

--------------------------------------------------------------------

By Darla

The Courier-Journal

After feeling the pain of having blood drawn, the last thing Zachary

Whalen wanted was to get stuck with a needle again.

So the 10-year-old from Buckner agreed to have an experimental,

medicated patch placed on his arm to numb the skin before having blood drawn a

second time.

The difference was dramatic, his mother said. ''It just didn't seem

to hurt him,'' SuzAnne Whalen said. ''He didn't flinch. He held real still. He

didn't grimace.''

The patch, tested earlier this year at Kosair Children's Hospital,

could be the key to ending the traumatic scenes that often occur when parents

take their children for blood tests and immunizations.

The drug-delivery system developed by Vyteris, a Fair Lawn, N.J.,

medical-research company, underwent a trial at Kosair from January to June. The

company plans to file an application with the federal Food and Drug

Administration within about a month and hopes to have the patch on the market

within a year.

If it is approved as an effective tool for numbing the skin,

procedures could be done ''without having to really stress the child,'' said Dr.

Janice Sullivan, a Louisville pediatrician who led the study of the patch at

Kosair.

''Many times those children squirm and move around and it takes a

couple of adults to hold them down,'' Sullivan said.

The adhesive patch, which contains the local anesthetic lidocaine,

works through a process called iontophoresis, in which a tiny electrical current

drives the medication into the skin, Sullivan said.

The patch is attached to a pre-programmed controller, so all the

healthcare worker does ''is hit a button and it does what it has to do,'' said

Garrison, vice president of business development for Vyteris.

Garrison declined to say how much money the company has invested in

the patch. But if it receives FDA approval, it will be significant for

pediatricians and patients, Sullivan said. The patch appears to work more

quickly -- in about 10 minutes -- and more deeply in the skin than anesthetic

cream, a current option.

Iomed, a competitor in Salt Lake City, has had a similar product on

the market called ''Numby Stuff'' since 1997. Iomed says it works just as fast

as Vyteris' product. However, Iomed stopped aggressively marketing the product

after finding that some hospitals weren't willing to pay for it, according to

Bob Lollini, Iomed's chief operating officer.

Sullivan said the Vyteris patch was tolerated better by patients

than Numby Stuff, which she said caused them more discomfort than the patch.

Numby Stuff costs about $6 per dose, Lollini said. Garrison said a

price for the patch has not been set.

Garrison said the FDA's approval of the patch will depend on whether

the trials prove that it is safe and effective.

There is increased emphasis on the importance of managing children's

pain, said Sullivan, medical director of the Kosair Charities' Pediatric

Clinical Research Unit and an associate professor in the Department of

Pediatrics at the University of Louisville.

Right now, it's common for intravenous lines to be placed or blood

to be drawn from children without anything being given for pain or discomfort,

but ''hopefully we will remedy that,'' she said.

Such decisions are up to a doctor's discretion, she said, but

''we're always looking for better ways to do things so that children do not have

discomfort or pain.''

The American Academy of Pediatrics and the American Pain Society

issued a joint statement in September stressing the need for health-care

professionals to eliminate or ease children's pain when possible.

In the past, the extent of children's pain wasn't always recognized

because children weren't thought to experience pain like adults, Sullivan said.

Also, it can be harder in children than adults to determine how much pain

they're in, she said.

About 500 people, including adults as well as children age 5 to 17,

took part in clinical trials of the patch from November of last year to June in

various parts of the country, Garrison said.

Families were recruited at Kosair when children were brought in ''to

have blood drawn or were going to have a procedure done where they had to have

an IV placed,'' Sullivan said.

The trial at Kosair involved 48 children and youths, half of whom

received a placebo, Sullivan said. Both parents and children were asked to rate

the level of pain. Medical personnel examined the children's skin for irritation

right after the patches were used and 24 hours later. Sullivan reported only a

mild redness of the skin in some cases and Garrison said similar reactions were

reported at other study sites.

Some children also reported feeling tingling when the patch was

first applied but said it quickly went away, Sullivan said.

Renea Lawrence, 12, of La Grange, felt warmth and tingling from the

patch when she took part in the study but still found the experience preferable

to having blood drawn without the patch.

''Without the patch, you could feel it when they stuck the needle in

your arm,'' she said. ''With the patch, you didn't,'' she said.

Her mother, Tammie Lawrence, said she thinks the patch would be

beneficial for children who fuss and try to get away from nurses when they have

to be stuck with a needle. She also could see it being useful for adults when

nurses have trouble finding a vein. ''I think, 'Lord, how much easier this would

be if somebody had numbed that site.' ''

During the study, Zachary Whalen said he was ''kind of scared''

because he knew that he only had a 50 percent chance of getting the real

product, but he wanted to try it just in case it worked.

Both he and Renea said they also liked the idea of being able to

help other children by participating in the research.

Zachary's mother, SuzAnne Whalen, is an oncology nurse at Kosair.

She said the patch would also ease immunizations: ''I think sometimes we forget

as adults what a traumatic experience even a little stick is for a child.''

^^ Back to top

Home · News · Sports · Business · Features · Louisville Scene

· Classifieds · Jobs · Cars · Homes · Marketplace · Contact Us · Search

Copyright 2001 The Courier-Journal.

Use of this site signifies your agreement to the Terms of Service (updated

8/7/2001).

Send questions and comments to The Webmaster.