Babies and unnecessary pain in research

A Reuters news service article this week reported that many babies are subjected to excessive or unnecessary pain in the course of medical research.  The article provided a link to an online report from the journal Acta Paediatrica.

The authors of the article in question (freely available through the link above) summarized their review of 46 recent (previous 2 ½ years) clinical trials testing analgesic treatments for pain caused by medical procedures performed on neonates—babies in the first month of life.  As anyone who has visited the doctor knows, medical procedures can cause pain, sometimes more, sometimes less.

The article’s authors found that a majority of the studies used a concurrent control group that did not receive any analgesia, or placebo, to compare with an experimental analgesic drug or method.  The problem with that is that there are numerous standard pharmacologic and non-pharmacologic analgesic methods that may be used for neonates and older infants.  By denying those to some subjects, the investigators did a disservice to these neonates, the authors argue.  Their argument is entirely reasonable.  They further find fault with ethics committees that approve such research, journals that publish the results, and parents of the infants, who provided consent either out of ignorance or for some other unknown reason.  All of this should stop, they argue, in favor or research designs in which all subjects receive at least standard-of-care analgesia.

This looks like an easy one: a fundamental criterion for ethical research on human subjects is that risks be minimized to the extent possible and reasonable, and consistent with good scientific and medical practice.  Further, risks of research must be reasonable and proportionate to the likely benefits, direct (to the subjects) or indirect (to society at large, in the form of useful knowledge gained).  On one level, what we have here is unethical use of placebos.

As straightforward as this may be, I bet it is something that can easily get by IRBs/ethics committees.  I don’t follow pediatric research, for example, and had not known about some of the standard analgesic methods.  Several are quite simple—swaddling or stroking the baby, warming a heel before a pinprick, or giving the baby some sugar solution, for example.  I had no idea these had analgesic effect.  (I’m a father of two, but my sons are grown, and it’s been a while…)

To dig this information out may take rather more scholarship than most IRB members—scientific or non-scientific—are inclined or able to do.  But it’s essential.  Even more essential is proper scholarship by the researchers, who should know better, to design studies that are as ethical as possible.

A further point:  procedures that adults may not think so bad, like a vein stick or heel stick to draw blood, may hurt a baby like the devil.  The Reuters article cited separate research showing that needle pricks cause babies severe pain, and an expert in the study of pain was quoted as saying that a heel prick could hurt a baby all the way up to the knee.

Again, I had no idea.  Certainly medical practice should take this into account, and I imagine it does or it will.  But a simple blood draw on an adult is typically considered “minimal risk,” which is defined as causing no more pain or discomfort than is ordinarily encountered in normal daily activities of life or routine medical examinations or tests.  The implication is that even routine blood testing in infants should be considered more than minimal risk.  And ethical guidelines for research on children demand that more-than-minimal-risk studies in children clear a higher benefits hurdle than similar research in adults.

So, something else to watch out for.

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