Dose response of PEG 3350 for the treatment of childhood fecal impaction.

OBJECTIVE: To investigate the efficacy and safety of polyethylene glycol (PEG) 3350 in the treatment of childhood fecal impaction.

METHODS: This was a prospective, double-blind, parallel, randomized study of 4 doses of PEG 3350; 0.25 g/kg per day, 0.5 g/kg per day, 1 g/kg per day, 1.5 g/kg per day, given for 3 days in children with constipation for >3 months and evidence of fecal impaction.

RESULTS: Forty patients completed the study (27 boys, median age 7.5, range 3.3-13.1 years). Disimpaction occurred in 75% of children, with a significant difference between the two higher doses and the lower doses (95% vs 55%, P <.005). All groups had an increased number of bowel movements during the 5-day study versus baseline, respectively: 6.5 versus 1.1 (P <.005), 8.0 versus 1.3 (P <.005), 10.9 versus 1.7 (P <.005), and 12.3 versus 1.4 (P <.005). Adverse effects included nausea (5%), vomiting (5%), bloating (18%), cramping (5%), and diarrhea (13%). Diarrhea and bloating were more prevalent (P <.02) in the higher-dose than in the lower-dose group. No clinically significant changes in electrolytes were noted.

CONCLUSIONS: The 3-day administration of PEG 3350 is safe and effective in the treatment of childhood fecal impaction at doses of 1 and 1.5 g/kg per day.