Efficacy of phenobarbital for benign convulsions with mild gastroenteritis: A randomized, placebo-controlled trial.

OBJECTIVE: This study was performed to evaluate the efficacy and safety of intravenous phenobarbital (PB) for benign convulsions with mild gastroenteritis (CwG).

METHODS: A randomized, single-blind, placebo-controlled trial involving patients with CwG was conducted at the Japanese Red Cross Society Himeji Hospital. Patients with CwG who had experienced two or more seizures were eligible. Patients were excluded if any anticonvulsant was used before enrollment. Patients who were allocated to the PB group were administered 10 mg/kg of PB intravenously. Patients who were allocated to the placebo group were administered 20 ml of normal saline.

RESULTS: From April 2016 to October 2018, 13 of 24 patients with CwG were randomized (PB group, n = 7; placebo group, n = 6; age, 1-3 years). Five of six patients in the placebo group had seizures after administration of placebo. However, patients in the PB group had no seizures after administration of PB, with a significant difference in efficacy between the two groups (P = 0.005). Five patients who had seizures after administration of normal saline were administered 10 mg/kg of PB, and no patients had a seizure thereafter. No significant differences were found in heart rate, blood pressure, or saturation of percutaneous oxygen between the two groups.

CONCLUSION: This is the first randomized controlled trial to evaluate the efficacy of an anticonvulsant for CwG. Intravenous PB at 10 mg/kg is effective and well tolerated for CwG.