A Dose Determination Study of Polyethylene Glycol 4000 in Constipated Children: Factors Influencing the Maintenance Dose

Abstract

Objectives: 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. JPGN 42:178-185, 2006.

A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in Management of Chronic Functional Constipation in Children

“…Indeed, 27% of subjects needed longterm medication for normal bowel pattern but the recovery rate in almost two third of cases is completely convincing to suggest PEG considering the safety and few side effects observed in this trial. Moreover, the medication was tolerated well in subjects with the age of less than two years and this is in agreement with the results reported in few previous trials [10,11]. The biochemical blood tests were in the normal ranges even though few studies have stated some imbalances in these measurements and another didn't accept these values' changes [16,17].…”

“…Furthermore, the presence of incontinence was another poor prognostic factor in this study as it has been mentioned by some authors [1,11].…”

“…Although PEG has been suggested with a dose of 0.2 -1.5 gr/Kg/day, the starting dose of 1 gr/Kg/day with adjustment every 3 days was recommended by Rahhal et al [1,5,[11][12][13][14][15]. The success rate was reported 55 to more than 90% [10][11][12][13][14]. Long-term therapy with a mean duration of 8.4 (3 -30) months was reported to be effective in chronic childhood constipation [15].…”

“…Different doses, durations, and success rates were used depending on study protocols [9][10][11][12][13][14][15]. Although PEG has been suggested with a dose of 0.2 -1.5 gr/Kg/day, the starting dose of 1 gr/Kg/day with adjustment every 3 days was recommended by Rahhal et al [1,5,[11][12][13][14][15]. The success rate was reported 55 to more than 90% [10][11][12][13][14].…”

“…Recently, Polyethylene glycols have received a great deal of attention due to effectiveness, palatability and safety and they were also recommended for subjects who have failed or are intolerant to other medications [7,9]. Different doses, durations, and success rates were used depending on study protocols [9][10][11][12][13][14][15]. Although PEG has been suggested with a dose of 0.2 -1.5 gr/Kg/day, the starting dose of 1 gr/Kg/day with adjustment every 3 days was recommended by Rahhal et al [1,5,[11][12][13][14][15].…”