RESUMEN
Background: Functional constipation (FC) is a common pediatric problem worldwide. The management of FC comprises of a short initial disimpaction phase followed by long-term maintenance phase. Currently, polyethylene glycol (PEG) is considered as standard disimpaction therapy in pediatric FC patients. The aim of our study was to compare the efficacy of polyethylene glycol 3350 monotherapy with polyethylene glycol 3350 and sodium picosulfate combined therapy in treating fecal impaction in pediatric FC patients. Methods: All children (aged >1 year) diagnosed with FC as per ROME IV criteria and presenting to the out-patient department of pediatric gastroenterology, hepatology and nutrition unit of a tertiary health centre in north Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely group A (receiving PEG 3350 monotherapy) and group B (receiving combined PEG 3350 plus sodium picosulfate therapy), over a period of 13 months. The outcome was evaluated as successful disimpaction with onset of loose/watery stools (Type-7 of Bristol stool chart scale). The success rates and mean time to disimpaction for two groups were computed and compared. Results: Eighty-one patients were randomized into two groups. The mean time to disimpaction was found to be significantly lower (p<0.001) for group B (2.37±1.16 days) when compared to group A (4.00±1.43 days). There was successful resolution of impaction in both groups. No adverse events were reported in either group. Conclusions: Combined PEG 3350 and sodium picosulfate therapy significantly reduces the disimpaction time when compared with PEG 3350 monotherapy in pediatric population, however both the therapies appear similar in achieving successful disimpaction.