New Research Ethics Blog

A hearty welcome to Nancy Walton who has just started blogging on research ethics -- Nancy is an RN and PhD, and Associate Director of the School of Nursing at Ryerson University in Toronto. Chris MacDonald, author of the Business Ethics Blog, (who has been busily blogging delightfully about monkey business in the last few days) is also co-piloting the research ethics blog. By way of welcome and introduction, we are cross-posting one of their blog entries today:

Children's Cold Remedies: the Ethics of Doing Research
From Reuters: Don't use cold drugs in kids under 4, industry says

Oral cough and cold medicines sold over the counter should not be used in children younger than 4 years old because of the risk of rare complications linked to inappropriate use, manufacturers said on Tuesday.

The move seems a good one. Maybe it's step 1 towards action on the real issue:

Currently, the medicines are available under decades-old FDA rules that allow over-the-counter products to be sold without clinical trials showing their risks and benefits.

"The bottom line remains the same: that these products have never been proven to work in children," said Diana Zuckerman, president of the National Research Center for Women & Families.

Two quick, relevant, rules of thumb for business ethics, rules that seem entirely relevant here:

1) Information asymmetry matters. If customers don't understand what they're getting, they're not making fully voluntary purchases, and even the most zealous fans of free markets say that markets don't work properly in the absence of reliable information. Parents almost certainly do not know that the safety & efficacy of these products have not necessarily been proven in clinical trials.

2) All the standards get cranked up a notch where kids are concerned.

Original post here.

How to keep our children pain-free

By: Jenny Walters

A recent article on Cnn.com entitled How to keep your kids pain-free by Elizabeth Cohen, dealt with 5 ways that a parent can use to help alleviate a child’s pain.

Dr. Jodi Greenwald, a pediatrician in Roswell, Georgia, uses a “secret weapon” for pediatric pain relief, a pinwheel. Dr. Greenwald stated: “Tell them to blow the pinwheel to make it turn, and you’re accomplishing two things…It distracts the child while they’re getting a shot and it makes them take deep breaths, which helps them relax.”[1]

Following giving birth to her son, Jennifer Crain discovered an anti-pain weapon too; a pacifier dipped in sucrose water. Nurses used this during her son’s circumcision. Researchers believe that sucking on sugar water changes the neurochemicals in the brain of the neonate.

Pediatric pain experts report that “sadly, too many children aren’t getting any pain relief, even something as simple as a pinwheel or sugar water.” A recent study in the Journal of American Medical Association, found that “four out of five babies in the neonatal intensive are unit received no pain relief when they had to undergo painful procedures.”

A study in France also found that U.S. doctors do not give pain relief to babies and children as often as they should. According to Dr. Brenda McClain, director of pediatric pain management at Yale-New Haven Children’s Hospital in Connecticut: “We may not see children’s pain as that severe. But pediatric pain needs to be taken seriously. However, most of the time I don’t think we see it that way.”

Below are five techniques that a parent can use to help alleviate a child’s pain:

1. For babies, ask about a pacifier dipped in sucrose water: Doctors say this works wonders in babies. If your pediatrician does not have sucrose water, you can make your own by dipping a pacifier into a mixture of one teaspoon table sugar and four teaspoons water. You can give your baby the pacifier about 30 minutes before a shot or procedure.

2. Ask for a topical pain cream: Creams can help take the sting out of a needle stuck. However, many doctors don’t use the topical creams, because they complain they take too long to work and they have to “sit there and wait until the cream takes effect.” You can ask your doctor for a prescription and apply the cream before you arrive at the doctor’s office. The cream needs to be applied 30 minutes to two hours before the procedure or shot.

3. Distract your child: Talking to your child about anything, but what is going on. Parents make the mistake of saying things like “We’ll get ice cream when it’s over” or “I know it hurts.” Instead it is better to talk to your child about good memories. For example, “Remember the time we went to Disney and you got to meet Mickey Mouse.”

4. Ask about alternative treatments: Acupuncture, music therapy, and hypnosis have all been used to treat children’s pain.

5. Don’t be afraid of opiates: According to pediatric pain experts, opiates can help a child in sever pain, and the risks are small. “It is very rare for children to get more pain medicine than they need or to get addicted to pain medicine” according to pain management program at the Seattle Cancer Care Alliance.

Overall, if your child is not getting enough pain relief, you, as the parent, may have to step in.

This article was not only important to me as a parent, but also as a neonatal intensive care nurse. In the neonatal intensive care unit (NICU), we used a specific pain scales designed specifically for the neonates, and we used sugar water and various pain medications to help alleviate the neonate’s pain.

I have to disagree somewhat with the research findings of “four out of five babies in the neonatal intensive are unit received no pain relief when they had to undergo painful procedures.” Pain was one the biggest concerns in the NICU. We were adamant about preventing and managing the neonate’s pain. Although there are and will always be a hand full of nurses and doctors who do not make pain management their priority, the majority of nurses and doctors are very much so concerned with pain management for neonates and children alike.

[1] Cohen E. How to keep your kids pain-free. July 2008. Available at: http://us.cnn.com/2008/HEALTH/07/10/ep.child.pain/index.html. Accessed on July 18, 2008.

That's One Fat Baby!

by Emily Stephens

According to a recent study, child care may lead to rather chunky infants. A University of Illinois study collected data on more than 8,100 nine-month old babies, who were weighed and measured repeatedly between 2001 and 2002.

Fifty-five percent of the infants received daily care from someone other than a parent. Infants in part-time care gained 0.4 more pounds over nine months that those cared for by parents, and even those cared for by relatives gained 0.35 more pounds. Researchers believe this is primarily due to lack of breast-feeding and early introduction to solid food. In fact, other studies suggest breast-feeding for the first year of life may actually instill a physical protection against obesity.

Dr. David Katz, director of Yale’s Prevention Research Center warns that the threat of obesity is a new challege in America's nurseries. "Studies show obesity emerging as a problem even in the first year of life. This, in turn, results in a higher risk of diabetes in youth, and lifelong obesity and its many consequences."

Just how many infants are placed prematurely into day care? Back in March 1970, 24% of working mothers had children under two-years old enrolled in some form of care. By March 1984 that figure jumped to 46.8%. More currently, it is estimated that only 25% of infants are cared for by a parent in their own homes. The other 75% are watched by a baby-sitter or local family day care group (most often run out of a neighbor’s home). More startling is that only 6% of infants and 12% of children under two-years-old are enrolled in licensed center-based day care (U.S. Dept. of Commerce, June 1982). Furthermore, the choice of care is most often based upon affordability and convenience rather than quality.

After reading all those statistics, you can imagine how child care obesity could become a very real problem. Low-income families don’t necessarily have their pick’o’the litter when it comes to affording day care. Quality infant rearing can understandably take a back seat to making ends meet. Some studies do show, however, that average day care can benefit low-income children by preventing the IQ drop that typically takes place between the ages of 12 and 30 months for those living at home. At least these children have some room to benefit from the situation. The bottom line, however, is that the choice of care is more often determined by cost and availability, than quality.

Food choices served at day care also play a critical role in intellectual development of children. The July issue of the Archives of Pediatrics & Adolescent Medicine reported a study where Guatemalan children were given a protein-rich enhanced nutritional supplement between 1969 and 1977, and other children received sugary beverages. Between 2002 and 2004, almost 1,500 participants were given intelligence tests. As it turns out, the adults who were given the supplement early in their youth scored better on intelligence tests regardless of how many years they spent in school.