Controlled Trial of Gastric Electrical Stimulation in Children

Children and adolescents with severe nausea and vomiting that do not respond to medical therapy represent a challenging clinical population. Gastric electrical stimulation (GES) has been used as a treatment option for patients with refractory symptoms, but controlled trials in children are limited. This single-blinded, sham-controlled clinical trial evaluated the short-term effects of temporary gastric electrical stimulation in pediatric patients with refractory nausea and vomiting. Participants underwent placement of a temporary pacing lead through a nasogastric tube connected to an external stimulator. After placement, the stimulator remained OFF for the first four days followed by ON for the next four days. Participants were blinded to the stimulation status. Baseline data included demographic characteristics, medical history, nutritional status, and symptom assessments using the Symptom Monitor Worksheet (SMW). Participants also completed a nutrient drink test to evaluate tolerance to oral intake. Symptom scores and nutrient drink test volumes were reassessed at the end of each study phase. The primary objective of the study was to evaluate changes in nausea and vomiting symptoms during sham and active stimulation phases. Secondary objectives included evaluating changes in symptom severity and frequency across gastrointestinal symptoms and assessing tolerance to nutrient intake during the study periods. This study aims to better understand whether gastric electrical stimulation may improve symptoms and oral intake in children with refractory nausea and vomiting and to inform future therapeutic approaches for this population.