title: A dose determination study of polyethylene glycol 4000 in constipated children: factors influencing the maintenance dose.
abstract: 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.
authors.affiliation: 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
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
authors.forename: Bernard
authors.initials: B
authors.lastname: Leluyer
authors.forename: Fatme
authors.initials: F
authors.lastname: Amar
authors.forename: Nicolas
authors.initials: N
authors.lastname: Kalach
authors.forename: Pierre-Henri
authors.initials: PH
authors.lastname: Benhamou
authors.forename: Olivier
authors.initials: O
authors.lastname: Mouterde
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Vannerom
mesh_terms: 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
chemical_list: D002400:Cathartics; D011092:Polyethylene Glycols