STOP PAIN TRIALS ON BABIES: STUDY
Poked with needles, then given placebos
Scientists are routinely hurting newborn babies and not giving them treatment for the pain, a practice that must stop, says a new Canadian co- authored study that highlights an unusual research-ethics debate.
Most of the trials on pain t herapy for babies conducted in the past three years had comparison groups where the tiny patients received a placebo or nothing at all after being poked with needles or lanced, the study found.
Given evidence that such pain can actually contribute to long- term development problems, the research method is clearly unethical, a McGill University nursing professor and her Italian colleague argue in the journal Acta Paediatrica.
They urge research-ethics boards to deny approval of such trials and medical journals to refuse to publish their results.
“I’ve seen babies as small as 24 weeks gestational age show a very clear facial grimace ( in response to pain),” said co-author Celeste Johnston in an interview.
“I hope this article will bring it to the forefront that it is an issue, because I think some people just don’t think about it.”
Researchers have argued they need to compare the pain treatment they are studying to a placebo to get a view of whether it works.
But Johnston, a professor emeritus at McGill, said they should be measuring the experimental method against something proven effective, even if that means the trial results are less clear-cut.
The studies that she and colleague Carlo Bellieni of Siena’s University Hospital reviewed looked mostly at such non- pharmacological tactics as putting sucrose in the infants’ mouths, breastfeeding, having skin- to- skin contact with a parent, or using a pacifier.
Almost two- thirds of the 45 “neonate” pain studies published worldwide in the 30 months ending last June gave babies in the control group — the patients used as a comparison to the experimental treatment — either nothing or a placebo, they reported. In some cases, researchers were studying procedures — such as eye exams or suctioning of the airways — for which there is no proven, effective pain relief. But even in trials where evidence shows pain can be alleviated — mostly involving heel pricks or needles to draw blood — 66 per cent failed to treat control- group babies, the researchers found.
It was not so long ago that the scientific community believed newborn babies did not feel pain at all, a notion that crumbled with studies that emerged in the 1980s.
It’s an important issue because newborns, especially preemies who have to stay in an intensive-care unit, are subject to multiple, painful procedures, Johnston said.
Research by the likes of Ruth Grunau, a University of British Columbia neuroscientist, even suggests the very premature suffer developmental problems as a result of the pain they suffered in hospital.
The stress of a single painful event can cause blood-saturation levels to drop, requiring a baby to be on oxygen, said Johnston. Even heel sticks are significant for patients whose heels are the size of an adult fingertip, she said. “It’s like sticking a knife in your foot.”
An editorial that accompanied Johnston’s study called for an end to such trials, noting that “first do no harm” is a fundamental principle in medicine.
There are signs the practice has already changed in places. One trial conducted at Wayne State University compared babies’ responses to a heel lance when given sucrose, versus receiving a placebo. Though published in 2015, it was based on data collected eight years ago, the lead researcher said Wednesday. Since then, the university has barred using placebos in newborn pain studies, said Victoria Tutag Lehr, a pharmacy professor at Wayne State.
“We no longer would conduct this kind of trial,” she said. “I don’t want to be turned out as this unethical, beastly researcher.”