Gastric electrical stimulation for children with refractory nausea and vomiting: A sham-controlled trial.

OBJECTIVES: Gastric electrical stimulation (GES) improves symptoms in children with refractory nausea and vomiting, but pediatric evidence is limited to observational studies. We conducted the first controlled trial of GES in children. METHODS: We performed a single-blind, sham-controlled trial of temporary GES in children using a nasogastric lead. After endoscopic lead placement on study day 1, the stimulator was OFF for 4 days and then ON for 4 days. Participants were blinded to stimulation status. Symptom Monitor Worksheet (SMW) scores and nutrient drink test volumes were collected at baseline (day 1), end of the OFF phase (study day 5), and end of the ON phase (study day 9). RESULTS: Thirty children (83% female, median age 16 years) were included. All carried a clinical diagnosis of gastroparesis, although only 53% had delayed gastric emptying on scintigraphy; 40% also had functional dyspepsia. Average SMW scores improved from baseline during the OFF phase (β = -0.59, p < 0.001) and improved further when the stimulator was ON (β = -0.42, p = 0.005). Both symptom frequency and severity improved over time. Exploratory analyses showed reductions in postprandial fullness, nausea, and vomiting scores during active stimulation. Maximum tolerated volume during the nutrient drink test increased significantly only when the stimulator was ON (β = 38.9 mL, p = 0.01). After the trial, 25 of 30 participants (83%) proceeded with permanent GES implantation. CONCLUSIONS: In this sham-controlled trial, children with refractory nausea and vomiting demonstrated significant symptom improvement. When the stimulator was ON, nausea showed a numerically greater reduction, vomiting continued to improve and nutrient intake increased significantly. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT07474415 (https://clinicaltrials.gov/study/NCT07474415).