Safety and efficacy of polyethylene glycol 3350 plus electrolytes for the treatment of functional constipation in children

Introduction: Polyethylene glycol 3350 plus electrolytes (PEG + E) efficacy has been validated in some studies, but not many have evaluated its safety in children. The aim of our study was to evaluate the safety; renal, malabsorption or excessive production of gas and efficacy of PEG + E treatment in our paediatric population. Patients and methods: Fifteen patients who suffered functional constipation (Rome III criteria) were evaluated. Median age was 6.2 years (r 2-9). All patients had normal renal function. PEG + E were administered for 4 weeks (4WP). The mean dose was 0.44 g/kg/day, titrated according to age, weight and response. Urine screens (sodium and osmolality) were performed at the beginning and 4WP. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed at 4WP. To analyse the efficacy of the treatment, the number of stools per week and stool form type (Bristol stool scale) were recorded. Results: The number of stools per week was higher after 4 weeks (2.46 +/- 0.71 vs 5.29 +/- 1.68, P<.001), as well as the stool form score (2.47 +/- 1.24 vs 4.5 +/- 0.91, P<.001). No statistical differences were obtained between urine sodium and urine osmolality values at the beginning and 4WP. After 4WP the NIRA median values were normal in all patients [fat 4.45% (range (r) 3.6-7.09); nitrogen 0.78% (r 0.4-1); sugars 1.4% (r 0.47-2.35) and water 68% (r 59-74)]. Median breath hydrogen test was 7 ppm (r 2-18). Conclusions: No adverse effects on biochemistry values or gastrointestinal disturbances were observed. PEG + E can be recommended for the treatment of functional constipation in children. (C) 2010 Asociacion Espanola de Pediatria. Published by Elsevier Espana, S.L. All rights reserved.