New research indicates that babies are often put to a lot of unnecessary pain in clinical studies, potentially breaching international standards for ethical research. This in spite of the availability of proven pain relievers, the paper says.
They have discovered that in almost two-third of all instances where pain was inflicted, the babies got no treatment for their discomfort. This finding is certainly going to be shocking to a lot of people.
This is what the researchers wrote in Acta Paediatrica, a medical journal, “We are urging parents and ethics review boards to refuse studies that do not provide acceptable analgesia to all babies enrolled in studies, if such pain relief exists”. They have also asked medical journals not to publish studies that deny pain relief to control infants undergoing painful procedures.
Johnston is a past-president of the Canadian Pain Society, and an emeritus professor at the Ingram School of Nursing at McGill University in Montreal, Canada.
Minor procedures also cause measurable physiological changes in babies apart from the pain, she says. For instance, their heart rate and blood pressure could go up. Blood oxygen level can drop, and free radicals can get released into the bloodstream.
For their review, Johnston and Dr. Carlo Bellieni, a bioethicist and specialist in newborn care at Siena University Hospital in Italy, combed through clinical trials published between 2013 and June of this year.
Trial participants were divided into two groups, one receiving treatment under investigation, and the other received an inactive placebo or nothing. They specifically looked for studies in newborns examining various methods of pain relief for procedures like heel pokes or needle pricks, which are termed “minor”.
They discovered that in 32 of 46 trials, or 70%, babies in the control groups were exposed to painful procedures while receiving no treatment to ease their discomfort.