Journal of Pediatric Gastroenterology and Nutrition
39:197–199 © August 2004 Lippincott Williams & Wilkins, Philadelphia
Polyethylene Glycol for Constipation in Children Younger Than
Eighteen Months Old
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Sonia Michail, Elizabeth Gendy, Daniel Preud’Homme, and Adam Mezoff
Wright State University School of Medicine and The Children’s Medical Center, Dayton, Ohio, U.S.A.
ABSTRACT
Background: Polyethylene glycol (PEG) is a safe and effective
treatment for constipation in children older than 18 months.
Data on its safety and efficacy in infants are lacking. The goal
of this study was to determine safety, efficacy, and optimal
dose of polyethylene glycol powder for treatment of constipa-
tion in patients younger than 18 months.
Methods: The authors reviewed the charts of patients younger
than 18 months treated with PEG 3350 for constipation. The
initial dose, effective maintenance dose, response to therapy,
duration of therapy, and side effects were recorded.
Results: Twenty-eight patients younger than 18 months of age
treated with PEG were identified (3, age 0–5 months; 9, age
6–11 months; 16, age 12–17 months). Mean duration of therapy
Polyethylene glycol (PEG) is one of several agents
used for the treatment of chronic constipation of child-
hood. It is an osmotic agent that is almost completely
recovered in the stool after oral ingestion by healthy
subjects. Polyethylene glycol appears to have no effect
on active absorption or secretion of glucose or electro-
lytes, and there is no evidence of tachyphylaxis (1). The
safety and efficacy of small daily doses of electrolyte-
free PEG 3350 to treat constipation have been confirmed
in adults and in children 18 months of age and older (2).
However, the safety and efficacy of PEG 3350 in infants
and children younger than 18 months has not been re-
ported. The goal of this study was to describe the safety,
efficacy, and optimal dose of polyethylene glycol pow-
der for the treatment of constipation in children younger
than 18 months of age.
METHODS
We reviewed the charts of all infants and children younger
than 18 months who were treated for constipation with PEG
Received October 7, 2003; revised January 29, 2004; accepted April
20, 2004.
Address correspondence and reprint requests to Sonia Michail, The
Children’s Medical Center, One Children’s Plaza, Dayton, OH 45404,
U.S.A. (e-mail: sonia.michial@wright.edu).
197
was 6.2 ± 5 months (range, 3 weeks–21 months). Mean initial
dose was 0.88 g/kg/day (range, 0.26–2.14 g/kg/day). Mean ef-
fective maintenance dose was 0.78 g/kg/day (range, 0.26–1.26
g/kg/day). PEG relieved constipation in 97.6% of patients. One
infant experienced increased gas per rectum and four others
experienced transient diarrhea that resolved after adjusting the
dose.
Conclusion: Oral powdered polyethylene glycol at a mainte-
nance dose of 0.78 g/kg/day is safe and effective for patients
younger than 18 months. Dose and safety profiles are simi-
lar for those reported in older children. JPGN 39:197–199,
2004. Key Words: Polyethylene glycol—constipation. © 2004
Lippincott Williams & Wilkins
powder at our institution between January 2000 and October
2003. The diagnostic criteria for functional constipation in in-
fants and preschool children were adapted from Rasquin-
Weber et al. (3) and include 2 weeks of hard stools (the ma-
jority of stools), or firm stools two or fewer times a week in the
absence of structural, endocrine, or metabolic disease. All pa-
tients were evaluated at an initial visit and subsequent visits
every 8 to 12 weeks. Data were recorded on standard office
forms. The detailed history included frequency of defecation
and pain with bowel movements. As described elsewhere, stool
consistency was assessed by history on a scale of 1 to 5 as
follows: 1 ⳱ hard; 2 ⳱ firm; 3 ⳱ soft; 4 ⳱ mushy/loose; and
5 ⳱ watery (2).
Patients were examined and studies performed to investigate
an organic etiology if deemed appropriate by the managing
gastroenterologist. Patients were excluded if they had an or-
ganic etiology for constipation, such as Hirschsprung disease,
anorectal malformation, bowel obstruction, or systemic illness,
such as hypothyroidism, cystic fibrosis, or lead poisoning as-
sociated with constipation. They were excluded if they were
taking medication that could potentially change the frequency
or consistency of bowel movements. Diet therapy was tried
before initiating PEG 3350 therapy. Families were educated on
the pathophysiology of constipation and the rationale of
therapy. Initial dose, effective maintenance dose, duration of
therapy, response to therapy, and reported side effects were
recorded. No patient was placed on a clean-out protocol using
any other drug. PEG 3350 was administered orally, mixed in a
ratio of 17 g to 240 mL of fluid, as recommended by the
 198
manufacturer. Caregivers for small infants mixed PEG 3350 in
formula if it was the sole diet. After the initial dose, families
were asked to titrate the dose to obtain at least one nonformed
bowel movement daily. The change in dose was permitted
within 24 hours, if necessary. The duration of therapy and side
effects were retrieved from the chart. Information not available
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in the chart was obtained by telephone interview. Only one
family needed to be contacted by telephone.
Data Analysis
Data were gathered regarding the age of the infants, the
initial dose of PEG 3350, effective maintenance dose, duration
and response to therapy, and the development of any side ef-
fects. Paired Student t test and Wilcoxon signed rank test were
used to analyze the data. Data presented reflect mean ± stan-
dard deviation. P values less than 0.05 were considered statis-
tically significant.
RESULTS
Twenty-eight patients younger than 18 months of age
were treated with PEG 3350 between January 2000 and
October 2003 (3 patients, age 0–5 months, 9 patients, age
6–11 months, and 16 patients, age 12–17 months; range,
7 weeks–17 months). The stated ages reflect the age at
initiation of therapy. The duration of therapy averaged
6.2 ± 5 months (range, 3 weeks–21 months, see Table 1
for distribution). The mean initial dose prescribed by the
gastroenterologist was 0.88 g/kg/day (range, 0.26–2.14
g/kg/day). The initial dose was effective in 86% of pa-
tients and was increased in 14% of patients. The mean
effective maintenance dose was 0.78 g/kg/day (range,
0.26–1.30 g/kg/day), which was effective in relieving
constipation in 96.4% of patients. The correlation be-
tween initial and maintenance doses was statistically sig-
nificant (r ⳱ 0.609, P < 0.001, Fig. 1). On average, it
took approximately a week to reach the optimal mainte-
nance dose.
The mean frequency of bowel movements before
therapy was 2.2 ± 1 per week (range, 1–5; 71.4% had
fewer than two bowel movements a week). Mean stool
frequency improved after PEG 3350 therapy (8.4 ± 2.5;
range, 5.0–14.0; P < 0.001; Fig. 1). The mean stool con-
TABLE 1. Distribution of the length of treatment with
PEG 3350
Duration of therapy Number
(months) of patients
0–3 8 evaluated safety and efficacy of PEG 3350 in children
3–6 14
6–9 0
9–12 2 for drug therapy in children younger than 18 months are
12–15 2 uncertain. An uncontrolled trial of infants with functional
15–18 1 constipation showed that stool frequency normalized
18–21 1 with lactulose treatment (12). In this study, the mean
>21 0
J Pediatr Gastroenterol Nutr, Vol. 39, No. 2, August 2004
MICHAIL ET AL.
FIG. 1. Distribution and relationship between initial and mainte-
nance doses of PEG 3350. The correlation (r = 0.609) was sta-
tistically significant (P = 0.0004).
sistency score was 1.7 ± 0.5 before PEG 3350 therapy
(range, 1–3; 32% had a score of 1; 64% had a score of 2;
4% had a score of 3). The mean score improved signifi-
cantly (P < 0.001) to 3.8 ± 0.8 after therapy. Caregivers
of 71.9% of infants reported the infants experienced dis-
comfort with defecation. Decreased discomfort was re-
ported by caregivers of 45% of patients after therapy, and
an additional 50% reported complete relief of discom-
fort. Side effects were reported in 17.9% of patients. One
(3.6%) infant experienced increased passage of gas per
rectum, and four (14.3%) others experienced transient
diarrhea that resolved after dose adjustment.
DISCUSSION
Constipation continues to be a common disorder in
children, accounting for as many as 5% of primary care
visits and 25% of referrals to a pediatric gastroenterology
office (1). Polyethylene glycol 3350, a tasteless, odor-
less, water-soluble powder, has a high osmotic effect (4),
which has made it effective in treating constipation. Al-
though a dose of 17 g of PEG for 14 days relieves con-
stipation in adults (5), recent pediatric studies have
shown that a dose range of 0.6 to 0.8 g/kg daily is more
appropriate for therapy of constipation and encopresis in
older children (6–9). Studies comparing PEG 3350 with
lactulose in constipated children 2 years of age and older
have shown that PEG 3350 is more effective when used
at a dose of 10 mg/m2/day (2). Another study has shown
that fecal impaction can be successfully treated in chil-
dren older than 3 years of age at doses of 1 and 1.5
g/kg/day for 3 days (10), but that side effects such as
nausea, vomiting, bloating, flatulence, and abdominal
cramping were encountered.
Although the safety of PEG 3350 in adults has been
confirmed (11), published pediatric studies have all
older than 18 months. Thus, evidence-based guidelines
number of bowel movements per week before therapy
 POLYETHYLENE GLYCOL FOR CONSTIPATION
was 2.2. Most caregivers reported that subjects experi-
enced discomfort in association with bowel movements.
In the patients we reviewed, powdered polyethylene gly-
col at a maintenance dose of 0.78 g/kg/day was effective
in increasing the frequency of bowel movements and
improving stool consistency. Discomfort associated with
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defecation improved or resolved in most patients re-
viewed. PEG 3350 was well tolerated by the infants and
children in this study. Mild transient diarrhea occurred in
a small number of infants but spontaneously resolved
after dose adjustment.
Compliance was not monitored in this study. How-
ever, based on the success rate of therapy and the moti-
vation to relieve discomfort, we suspect that compliance
was good. The effective dose and safety profiles of PEG
3350 in infants with constipation are similar to those
reported in older children. Larger studies are needed to
validate the safety data in infants, especially those
younger than 6 months.
Acknowledgment: The authors thank Adrienne Stolfi for
assistance with the statistical analysis.
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J Pediatr Gastroenterol Nutr, Vol. 39, No. 2, August 2004