International Journal of Clinical Medicine, 2012, 3, 383-386
http://dx.doi.org/10.4236/ijcm.2012.35072 Published Online September 2012 (http://www.SciRP.org/journal/ijcm)
1
A Comparative Trial: The Safety and Clinical Efficacy of
PEG 3350 and Liquid Paraffin in Management of Chronic
Functional Constipation in Children
Abbaslou Parvin1*, Abbaslou Farzaneh2, Hosseini Nasab Ali3
1Department of Pediatric Gastroenterology, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran; 2Depatment
of Pediatrics, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran; 3Department of Pediatric Infectious Dis-
ease, Afzalipour Clinical Research Unit, Kerman University of Medical Sciences, Kerman, Iran.
Received May 26th, 2012; revised June 28th, 2012; accepted July 14th, 2012
ABSTRACT
Background: Constipation is one of the most common problems in the pediatric age group. In the vast majority,
chronic constipation is idiopathic or functional. In addition to education and behavioral changes, disimpaction and
maintenance treatment with medications are the main pillars of successful outcome. The medications are variably effec-
tive and have potential side effects. Objectives: The current clinical trial was designed to evaluate clinical efficacy of
polyethylene glycol (PEG) 3350 and liquid paraffin in chronic functional constipation. Besides, subjects were followed
carefully for the side effects. Material and Methods: This study was involved 110 children suffering from chronic
functional constipation. They were placed into two different groups, randomly. Each group was treated with PEG 3350
or liquid paraffin. The clinical efficacy and side effects were monitored. Results: After disimpaction with bisacodyl
suppositories or combined with Mineral oil enemas in hard fecal impaction, maintenance therapy with PEG 3350 or
liquid paraffin was started. The treatment duration and efficacies were not different between the two groups. Further-
more, serious adverse drug reaction was not observed. The family history of constipation and presence of incontinence
were two worse prognostic factors. Conclusion: No difference was observed between PEG 3350 and liquid paraffin in
chronic functional constipation in children in terms of their efficacies. They are safe and effective medications in this
age group.
Keywords: Children; Constipation; Liquid Paraffin; Polyethylene Glycol
1. Introduction
Constipation is a common disorder among children; as
many as 25% of visits to pediatric gastroenterologists are
for the treatment of this condition. Chronic constipation
in children often doesn’t have any organic cause and
called functional. From 2006, ROME III Diagnostic Cri-
teria have been defined to unify the functional constipa-
tion definitions [1-3].
Functional constipation may present with difficult and
infrequent defecation or incontinence. Urinary problems,
psychological disorders such as low self-esteem and de-
pression, chronic abdominal pain and decreased appetite
are other common presentations [1,2].
NASPGHAN recommended four important steps for
treatment of functional constipation: education, disim-
paction, prevention of rectal reimpaction and regular
follow up. Various disimpaction protocols using oral or
rectal routs have been published [4-6]. After disimpac-
tion, variety of laxatives for restoring a regular defeca-
tion pattern and preventing relapses has been used [1,2].
Polyethylene glycols (PEG) are osmotic and nonab-
sorbable compounds which are not metabolized by colonic
bacteria. PEG 3350 without electrolytes is available as a
powder and widely used to treat childhood constipation
because of its effectiveness, safety and palatability [1].
Liquid paraffin is the most used lubricant laxative and
composed of saturated hydrocarbons obtained from petro-
leum. Lipoid pneumonia is the most serious complication
and a reason to avoid administration to patients with
tendency for pulmonary aspiration [1,2].
This study was aimed to compare the clinical efficacy
and side effects of these two commonly used laxatives in
childhood functional constipation.
2. Material and Mothods
The current trial was performed from April 2010 until
*Corresponding author.

A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in
Management of Chronic Functional Constipation in Children
384
March 2011 in Afzalipour Hospital on 156 constipated
children who obtained ROME III Criteria. After educa-
tion, a booklet including all necessary information as
well as a symptom and medication diary for every month
of treatment were provided to each parent. Disimpaction
was managed with pediatric suppositories of bisacodyl (5
mg) two times a day or the rectal bisacodyl in combina-
tion with liquid paraffin enemas at a dose of 10 mL/Kg
body weight/dose (maximum 150 mL) two times a day in
hard fecal impaction.
Following successful disimpaction, patients received
PEG 3350 or liquid paraffin randomly as a maintenance
treatment. The questionnaire regarding demographic data,
growth measures, symptoms, past medical and family
histories and physical examination findings were recorded.
The children were followed through periodic appoint-
ments while the dose adjustment was advised to yield
one or two soft stools daily and the side effects were
monitored. When behavioral and dietary changes were
established and normal bowel pattern (≤2 smears in a
month, ≥3 bowel movements in a week without abdomi-
nal pain during maintenance therapy) were achieved for a
few months, the investigator decided to discontinue the
medication gradually. In addition, one month after the
complete discontinuation, patients were visited for re-
lapses. In fact, they would be considered as a complete
recovery case if they didn’t experience any relapse with-
out medication. If so, they called successfully treated
subjects and needed to continue the medication longer.
Moreover, during the follow up, retractable cases were
worked up for organic causes and the case would be ex-
cluded from the study if an organic etiology was found.
The collected data were analyzed by SPSS V16 soft-
ware. Furthermore, all criteria were carried out with α =
0.05 level of significance.
3. Findings
In this trial, 156 children aged 9 months to 11 years were
enrolled. 24 cases were excluded due to absence of
timely manner follow up and early cessation of medica-
tions. 17 retractable cases proceeded with further studies
for organic causes and didn’t complete the trial because
of finding organic etiologies. These secondary etiologies
included: hypocalcemia in 1, hypokalemia in 1, hypo-
thyroidism in 2, cow’s milk protein allergy in 2, ultra
short Hirshprung disease in 2, and anterior ectopic anus
in 8 subjects.
The rest of patients, 110 cases with mean age 36.76 ±
26.94 months, completed the study. They were 59 girls
and 51 boys. Constipation began in mean age 19.62 (2 -
78) months. Recorded symptoms included: withholding
behavior in 93.6%, decreased appetite in 62.5%, chronic
abdominal pain in 34.5% and incontinence in 25% of
cases. Moreover, urinary problems were reported in
21.8%; the most common was urinary tract infection.
The family history of constipation was positive in 22.7%
of subjects. Children nutritional status was assessed ac-
cording to Gomez and Waterlow Criteria: 45.5% of all
patients were mildly underweighted and 6.4% of them
were mildly stunted. Anogenital index was 0.44 ± 0.09
(0.35 - 0.65) in girls and 0.51 ± 0.11 (0.40 - 0.60) in boys.
What’s more, anal fissure in 62.7% and rectal fecal im-
paction in 35.5% of children were detected in the first
examination.
All cases with fecal impaction were free of impaction
in maximum of 5 days while 7.27 ± 2.25 doses of paraf-
fin enemas and rectal bisacodyl were administered. Next,
cases were randomly divided into two groups for main-
tenance treatment; the baseline characteristics of either
group were balanced. Fifty one cases received PEG 3350
with initial mean dosage 0.6 ± 0.16 g/Kg body weight/day
which was altered to optimal mean dosage 0.64 ± 0.24
g/Kg/day. In the next group, 59 children used liquid par-
affin. The starting paraffin dosage was 0.52 ± 0.15
mL/Kg/day and further adjustment resulted in 0.86 ±
1.53 mL/Kg/day.
In PEG group, 37 cases (73%) obtained complete re-
covery, and 14 patients (27%) were treated successfully.
In liquid paraffin group, 38 cases (64%) recovered com-
pletely, 19 cases (32%) were treated successfully and 2
children (4%) didn’t respond (Table 1). There was no
difference between the two groups in terms of full recov-
ery or successfully treatment rates (P Value = 0.333).
The length of the drug therapy to obtain successful
treatment in PEG group was 6.44 ± 3.05 months and in
liquid paraffin group was 6.96 ± 2.76 months without
any statistical difference (P Value = 0.355). The treat-
ment duration to complete recovery was 5.89 ± 2.60
months in PEG group and 6.27 ± 2.53 months in paraffin
group. The difference wasn’t statistically meaningful (P
Value = 0.119).
Recovery rate in continent patients was higher than
incontinent subjects (P Value < 0.0001). Furthermore,
recovery rate was lower in children with positive family
history of chronic constipation in first-degree relatives (P
Value < 0.0001). In addition, the recovery rate didn’t
Table 1. The comparison of PEG and liquid paraffin effi-
cacy in childhood functional constipation.
Drug
Drug effect Paraffin PEG P Value
Treatment Failure 2 (4%) 0 0.333
Successful Treatment 19 (32%) 14 (27%) 0.333
Complete Recovery 38 (64%) 37 (73%) 0.333
Total 59 (100%) 51 (100%)

A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in
Management of Chronic Functional Constipation in Children
385
have any differences in children less or more than 2 years
old and between each different sexes (P Value > 0.05).
Considering the side effects, diarrhea in 9.8%, abdomi-
nal pain in 9.8%, vomiting in 2% and dark color stool in
2% of patients in PEG group were recorded. Oil seepage
in 25.4%, diarrhea in 10.7% and abdominal pain in 5.4%
of liquid paraffin-treated cases occurred.
In PEG group, only 30 cases signed the written consent
forms for doing some biochemical blood tests including
blood sugar, Na, K, Ca, P, BUN, Cr, SGOT and SGPT at
the end of the medical treatment. All of the blood works
were reported normal except mildly elevation of SGPT in
2 cases.
4. Discussion
Laxatives are the most important part in constipation
management. Although some authors mentioned that there
is no sufficient data for supporting better laxatives effi-
cacy than placebo, the growing body of literature rec-
ommends these medications [1,2,7].
Liquid paraffin with high compliance rate has a few
limitations especially in a patient with pulmonary aspira-
tion risk [1,2,8]. 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 [9-15].
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 ad-
justment every 3 days was recommended by Rahhal et al.
[1,5,11-15]. The success rate was reported 55 to more
than 90% [10-14]. Long-term therapy with a mean dura-
tion of 8.4 (3 - 30) months was reported to be effective in
chronic childhood constipation [15]. In this study, 73%
of PEG group was completely recovered and 27% were
successfully treated with a dose of 0.64 gr/Kg/day for
about 6 months. Indeed, 27% of subjects needed long-
term medication for normal bowel pattern but the recov-
ery rate in almost two third of cases is completely con-
vincing to suggest PEG considering the safety and few
side effects observed in this trial. Moreover, the medica-
tion 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 measure-
ments and another didn’t accept these values’ changes
[16,17]. In paraffin group, the success rates and treatment
length were similar to the PEG group. In addition, opti-
mal paraffin dosage was 0.86 mL/Kg/day without any
serious side effects and the most common side effect was
oil seepage that could be annoying in some patients.
Current data bases were searched for comparative tri-
als focusing on laxatives in children chronic constipation.
In two studies, liquid paraffin efficacy was higher than
Sena and lactulose [8,18]. Other studies were reported
better PEG efficacy than lactulose and similar efficacy
with Magnesium hydroxide [10,19]. Karami et al. per-
formed a comparative trial on PEG and liquid paraffin in
chronic childhood functional constipation and stated their
efficacies were remarkable that it was compatible with
this study, but they administered higher dosages of
medications and didn’t evaluate the short-term outcome
after drug discontinuation [14].
Positive family history of chronic constipation was a
worse prognostic factor in this study; it may be due to
common genetic background and environmental factors
in a family. Furthermore, the presence of incontinence
was another poor prognostic factor in this study as it has
been mentioned by some authors [1,11].
5. Conclusion
Polyethylene glycol 3350 and liquid paraffin are safe and
highly effective medications in pediatric functional con-
stipation even during infancy. The positive family history
of chronic constipation and incontinence were poor
prognostic factors for complete recovery. One third of
chronic constipated patients need to continue the medi-
cations for probably years. Future studies should focus
on long-term outcome.
REFERENCES
[1] R. T. Rahhal and A. Uc, “Motility Disorders, Functional
Constipation, in Walker’s Pediatric Gastrointestinal Disor-
ders,” In: S. I. Kleinman, O. Goulet, et al., Eds., BC
Decker Inc., Hamilton, 2008, pp. 675-682.
[2] V. Loening-Baucke, “Constipation and Encopresis, in
Pediatric Gastrointestinal and Liver Disease,” In: H. J.
Wyllie, Ed., Saunders Elsevier, Philadelphia, 2006, pp.
177-191. doi:10.1016/B978-0-7216-3924-6.50015-9
[3] S. M. Mugie, M. A. Benninga and C. D. I. Lorenzo,
“Epidemiology of Constipation in Children and Adults: A
Ssystematic Review,” Best Practice & Research Clinical
Gastroenterology, Vol. 25, No. 1, 2011, pp. 3-18.
doi:10.1016/j.bpg.2010.12.010
[4] N. Youseff, J. M. Peters, W. Henderson, S. Shultz-Peters,
D. K. Lockhart and C. Di Lorenzo, “Dose Response of
PEG 3350 for the Treatment of Childhood Fecal Impac-
tion,” Journal of Pediatrics, Vol. 141, No. 3, 2002, pp.
410-414. doi:10.1067/mpd.2002.126603
[5] V. Tolia, “Use of a Balanced Lavage Solution in the
Treatment of Fecal Impaction,” Journal of Pediatric Gas-
troenterology and Nutrition, Vol. 7, No. 2, 1988, pp. 299-
301. doi:10.1097/00005176-198803000-00025
[6] V. Tolia, C. H. Lin and Y. Elitsur, “A Prospective Ran-

A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in
Management of Chronic Functional Constipation in Children
386
domized Study with Mineral Oin and Oral Lavage Solu-
tion for Treatment of Faecal Impaction in Children,” Ali-
mentary Pharmacology & Therapeutics, Vol. 7, No. 5,
1993, pp. 523-529.
doi:10.1111/j.1365-2036.1993.tb00128.x
[7] M. A. Pijers, M. M. Tabbers, M. A. Benninga and M. Y.
Berger, “Currently Recommended Treatments of Child-
hood Constipation Are Not Evidence-Based, a Systematic
Literature Review on the Effect of Laxative Treatment
and Dietary Measures,” Archives of Disease in Childhood,
Vol. 94, No. 2, 2009, pp. 117-131.
doi:10.1136/adc.2007.127233
[8] N. Urganci, B. Akyildiz and T. B. Polat, “A Comparative
Study: The Efficacy of Liquid Paraffin and Lactulose in
Management of Chronic Functional Constipation,” Pedia-
trics International, Vol. 47, No. 1, 2005, pp. 15-19.
doi:10.1111/j.1442-200x.2004.02001.x
[9] E. A. Bell and G. C. Wall, “Pediatric Constipation Therapy
Using Guidelines and Polyethylene Glycol 3350,” Annals
of Pharmacotherapy, Vol. 38, No. 4, 2004, pp. 686-693.
doi:10.1345/aph.1D297
[10] I. Voskuij, F. De lorijn, W. Verwijs, P. Hogeman, J. Heij-
mans, W. Mäkel, J. Taminiau and M. Benninga, “PEG
3350(Transipeg) versus Lactulose in the Treatment of
Childhood Functional Constipation: A Double-Blind,
Randomized, Controlled, Multicenter Trial,” Gut, Vol. 53,
No. 11, 2004, pp. 1590-1594.
doi:10.1136/gut.2004.043620
[11] C. Dupont, B. Leluyer, F. Amar, N. Kalach, P. H. Ben-
hamou, O. Mouterde and P. Y. Vannerom, “A Dose De-
termination Study of Polyethylene Glycol 4000 in Con-
stipated Children: Factors Influencing the Maintenance
Dose,” Journal of Pediatric Gastroenterology and Nutri-
tion, Vol. 42, No. 2, 2006, pp. 178-185.
doi:10.1097/01.mpg.0000189349.17549.a9
[12] S. Nurko, N. N. Youssef, M. Sabri, A. Langseder, J.
McGowan, M. Cleveland and C. Di Lorenzo, “PEG 3350
in the Treatment of Childhood Constipation: A Multicen-
ter, Double-Blinded, Placebo-Controlled Trial,” Journal
of Pediatrics, Vol. 153, No. 2, 2008, pp. 254-261.
doi:10.1016/j.jpeds.2008.01.039
[13] J. A. Dipalma, M. B. Cleveland, M. C. Gowan and J. L.
Herrera, “A Comparison Polyethylene Glycol Laxative
and Placebo for Relief of Constipation from Constipating
Medications,” Southern Medical Journal, Vol. 100, No.
11, 2007, pp. 1085-1090.
doi:10.1097/SMJ.0b013e318157ec8f
[14] H. Karami, M. Khademlo and P. Niari, “Polyethylene
Glycol Versus Paraffin for the Treatment of Childhood
Functional Constipation,” Iranian Journal of Pediatrics,
Vol. 19, No. 3, 2009, pp. 255-261.
[15] D. S. Pashankar and W. P. Bishop, “Efficacy and Optimal
Dose of Daily Polyethylene Glycol 3350 for Treatment of
Constipation and Encopresis in Children,” Journal of Pe-
diatrics, Vol. 139, No. 3, 2001, pp. 428-432.
doi:10.1067/mpd.2001.117002
[16] D. I. Pina, M. M. Barba, O. S. Canton, M. A. Beltran, S.
R. Ferreiro, R. V. Casas and J. L. Rey, “Safety and Effi-
cacy of Polyethylene Glycol 3350 Plus Electrolyes for the
Treatment of Functional Constipation in Children,” Ana-
les de Pediatría, Vol. 75, No. 2, 2011, pp. 89-95.
[17] S. H. Bae, “Long-Term Safety PEG 4000 in Children
with Chronic Functional Constipation: A Biochemical
Perspective,” Korean Journal of Pediatrics, Vol. 53, No.
7, 2010, pp. 741-744. doi:10.3345/kjp.2010.53.7.741
[18] J. M. Sondheimer and E. P. Gervaise, “Lubricant versus
Laxative in the Treatment of Chronic Functional Consti-
pation of Children: A Comparative Study,” Journal of
Pediatric Gastroenterology and Nutrition, Vol. 1, No. 2,
1982, pp. 223-226.
doi:10.1097/00005176-198201020-00012
[19] P. B. Gomes, M. A. Duarte and C. M. Mdo, “Comparison
of the Effectiveness of Polyethylene Glycol 4000 without
Electrolytes and Magnesium Hydroxide in the Treatment
of Chronic Functional Constipation in Children,” Journal
of Pediatrics, Vol. 87, No. 1, 2011, pp. 24-28.