Elsevier

The Journal of Pediatrics

Volume 141, Issue 3, September 2002, Pages 410-414
The Journal of Pediatrics

Dose response of PEG 3350 for the treatment of childhood fecal impaction,☆☆

https://doi.org/10.1067/mpd.2002.126603Get rights and content

Abstract

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. (J Pediatr 2002;141:410-4)

Section snippets

Design

The study was designed to test the efficacy and safety of 4 different doses of PEG 3350 in the treatment of fecal impaction in children. The design was a prospective, double-blind, parallel study. Patients enrolled were children examined in the pediatric gastroenterology clinic with complaints of chronic constipation and/or soiling and who had a fecal impaction. The primary outcome measure of the study was clearance of fecal impaction. Presence or absence of fecal impaction was assessed by

Results

Forty-one children fulfilled the inclusion criteria; 40 children (27 male, median age 7.5, range 3.3-13.1 years) completed the study. One child receiving a dose of 1.5 g/kg per day did not show up at the follow-up visit. Overflow fecal soiling occurred in 35 children, with 91% having it daily. Associated symptoms included straining (90%), hard consistency stools (85%), feeling of incomplete evacuation (55%), feeling of blockage (40%), and defecation only achieved using manual maneuvers such as

Discussion

In this prospective, double-blind, parallel study we found that children with fecal impaction can be treated effectively and safely with PEG 3350. Doses of 1.0 and 1.5 g/kg per day for 3 days were more effective than lower doses, regardless of age of patients, duration of symptoms, or severity of constipation. The effective doses can be administered in relatively small daily volumes.

The use of PEG-ELS–based solutions has become increasingly popular in the treatment of childhood constipation.3, 4

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Supported by Braintree Laboratories Incorporated, General Clinical Research Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, National Institutes of Health Grant No. M01RR00084.

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Reprint requests: Nader N. Youssef, MD, 3705 Fifth Ave at DeSoto St, Pittsburgh, PA 15213.

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