A dose determination study of polyethylene glycol 4000 in constipated children: factors influencing the maintenance dose.
OBJECTIVE
To determine the doses of polyethylene glycol (PEG) 4000 without additional salts allowing normal bowel habits in childhood functional constipation.


METHODS
This multicenter noncomparative study allocated children to 4 groups: 6-12 months, 13 months-3 years, 4-7 years, and 8-15 years. Constipation was defined as <1 stool/d for more than 1 month in children aged 6-12 months and <3 stools/w for more than 3 months in older children. Children randomly received either a nominal or a double starting dose. Treatment scheduled for 3 months could be adapted. Data were collected daily by the parents and rated at each visit by the investigator.


RESULTS
In the 96 children included, the median (interquartile) effective daily doses were by groups; 3.75 (2.50-5.00) g, 6.00 (4.00-7.43) g, 11.71 (7.00-16.00) g, and 16.00 (16.00-24.00) g, respectively, i.e., around 0.50 g/day/kg with a potential increment of the maintenance dose with higher initial dosages. More children had a final dosage identical to the initial one when started on the nominal dose (73%) than with the double one (42%, P < 0.003). More than 90% of children recovered normal bowel habits. Fecal soiling ceased in >60% of children with this symptom at enrolment. Fecal mass in the rectum and abdominal pain were markedly reduced and appetite improved.


CONCLUSIONS
A daily dose of PEG 4000 around 0.50 g/day/kg in children aged 6 months to 15 years is effective in more than 90% of constipated children and 60% of those with fecal soiling.
Dupont
Christophe
C
Service de Neonatologie, Hôpital Cochin-Saint-Vincent-de-Paul, bât. Marcel Lelong, 74-82 Avenue Denfert Rochereau, 75674 Paris Cedex 14, France. christophe.dupont@svp.ap-hop-paris.fr
Leluyer
Bernard
B
Amar
Fatme
F
Kalach
Nicolas
N
Benhamou
Pierre-Henri
PH
Mouterde
Olivier
O
Vannerom
Pierre-Yves
PY
D000293:Adolescent; D002400:Cathartics / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects* / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D005242:Fecal Incontinence / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D002400:Cathartics; D011092:Polyethylene Glycols