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.
Youssef
Nader N
NN
Division of Pediatric Gastroenterology, University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh, Pennsylvania, USA.
Peters
John M
JM
Henderson
Wendy
W
Shultz-Peters
Sandra
S
Lockhart
Danielle K
DK
Di Lorenzo
Carlo
C
D000293:Adolescent; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005244:Fecal Impaction / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D011446:Prospective Studies
D002400:Cathartics; D011092:Polyethylene Glycols