Should an IRB approve a placebo-controlled randomized trial of analgesia for procedural pain in neonates?

One of the most controversial issues in neonatology today is the appropriate treatment of procedural pain in the NICU. Infants in the NICU undergo numerous painful procedures. Policies and practices for the treatment of pain vary from NICU to NICU and from doctor to doctor. Numerous studies have been done to clarify the best methods of relieving pain, but the studies themselves are ethically problematic. What is the gold standard? How should we assess pain? When have we learned enough to consider certain practices as proven? Should proven practices be considered as the standard of care, even if we know that they are not widely used? In this ethics column, we asked experts in pain and palliative care to consider a proposed randomized trial for procedural pain in newborns and to discuss whether an institutional review board should approve the trial. Dr Bellieni is a neonatologist and bioethicist in Sienna, Italy. Dr Taddio is a pharmacologist at the Hospital for Sick Children in Toronto. Dr Linebarger is Medical Director of the Palliative Care Program at Children’s Mercy Hospital in Kansas City.