Should an IRB Approve a Placebo-Controlled Randomized Trial of Analgesia for Procedural Pain in Neonates?

Abstract

* Abbreviations: IRB — : institutional review board PIPP — : premature infant pain profile 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. The following proposal was submitted to an institutional review board (IRB) at a children’s hospital to study different interventions for procedural pain in newborns. ### Efficacy of Sucrose and Breast Milk as Analgesia for Procedural Pain in Newborns #### Background Numerous studies reveal that both oral sucrose and breast milk can reduce duration of crying in newborns after a heel stick.1 Repeated doses of sucrose during prolonged hospitals stays are associated with developmental problems. To better understand the efficacy of breast milk and sucrose, we want to test them against placebo. We will recruit 150 healthy full-term newborns. They will be randomly assigned into 3 groups of 50 infants: “Mother’s milk group”: each newborn will be given 2 mL mother’s milk 2 minutes before the procedure by using a syringe with the needle removed. … Address correspondence to John D. Lantos, MD, Children’s Mercy Hospital, 2401 Gillham Rd, Kansas City, MO 64105. E-mail: jlantos{at}cmh.edu