What happened to the principle of equipoise in the planning, designing and conducting of placebo-controlled trials for neonatal procedural pain?

We refer to the recent study published by Hsieh and colleagues1 comparing the effects of 10% glucose and expressed breast milk (EBM) on pain scores during heel lance in preterm infants. The enrolled infants underwent four heel lance procedures while receiving EBM, 10% glucose, water, or no intervention. Results demonstrated significantly lower pain scores for the EBM and 10% glucose groups than for the water and no intervention groups. However, all infants obviously experienced moderate pain (e.g., Premature Infant Pain Profile scores higher than 6) during the first 30  s after heel lance irrespective of the allocated group.
Source: Pediatrics and Neonatology - Category: Perinatology & Neonatology Authors: Tags: Letter to the Editor Source Type: research