Abstract | OBJECTIVE: 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.
|
Authors | Nader N Youssef, John M Peters, Wendy Henderson, Sandra Shultz-Peters, Danielle K Lockhart, Carlo Di Lorenzo |
Journal | The Journal of pediatrics
(J Pediatr)
Vol. 141
Issue 3
Pg. 410-4
(Sep 2002)
ISSN: 0022-3476 [Print] United States |
PMID | 12219064
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
|
Chemical References |
- Cathartics
- Polyethylene Glycols
|
Topics |
- Adolescent
- Cathartics
(administration & dosage, adverse effects, pharmacology)
- Child
- Child, Preschool
- Dose-Response Relationship, Drug
- Double-Blind Method
- Fecal Impaction
(drug therapy)
- Female
- Humans
- Male
- Polyethylene Glycols
(administration & dosage, adverse effects, pharmacology)
- Prospective Studies
|