Efficacy and tolerability of potassium citrate sachet versus solution in pediatric nephrolithiasis: A randomized clinical trial

Purpose: The aim of this study is to compare the efficacy of a novel sachet formulation of potassium citrate with its solution form in children with first-episode nephrolithiasis. Materials and methods: Of the 52 children initially recruited for this randomized clinical trial, 49 completed the study. Patients received potassium citrate in either solution form (n = 25) or sachet form (n = 24) at an equivalent dose for 1 month. Changes in urine and serum electrolytes, stone burden reduction, complications, drug tolerability, and drug portability were assessed using spot urine tests, abdominal ultrasonography, parent-reported visual analog scale (VAS), and parent-reported 5-point Likert satisfaction scale scores. Statistical analysis was performed using 1-way ANCOVA. Results: The changes in random urinary citrate to creatinine, oxalate to creatinine, calcium to creatinine ratios, and urinary pH and stone burden were comparable between the 2 groups ( P = 0.598, 0.281, 0.404, 0.054, and 0.991, respectively). The only complications observed were mild abdominal discomfort and nausea in 5 (10.2%) patients: 2 (8.3%) patients in the sachet group and 3 (12.0%) patients in the solution group ( P = 1.000). The VAS score was significantly lower in the sachet group (median [interquartile range (IQR)] = 0.0 [0.0–1.0]) compared with the solution group (median [IQR] = 2.0 [0.0–2.0], P = 0.001). Parents in the sachet group (median [IQR] = 4.0 [3.5–5.0]) were significantly more satisfied with drug portability compared with the solution group (median [IQR] = 2.0 [2.0–3.0], P < 0.001). Conclusion: The comparable efficacy of potassium citrate sachet and solution forms in modifying urine electrolytes and reducing stone burden, along with the sachet’s similar safety profile and significantly better tolerability and portability, makes it a promising alternative to the solution form.