Constipation is one of the most common intestinal problems in children, accounting for 3% to 5% of all visits to pediatricians. It is a symptom, not a disease. Fortunately, most constipation in infants and children is not caused by any serious medical illness. The cause of most constipation is functional or idiopathic (i.e. without objective evidence of a pathological condition), meaning there is no sign of injury or infection, blood, or anatomic abnormality to explain the very real symptoms. According to the researchers, constipation carries a host of physical and psychological consequences, and defecation anxiety is often implicated as a primary contributor to constipation. Children need help from their parents, and sometimes from a health care professional, to prevent or manage constipation.

EPIDEMIOLOGY OF CONSTIPATION AND SOILING:

Constipation in childhood is common, but it is much more frequent when dietary fibre intake is restricted. Fecal soiling occurs in 1%–3% of children aged 4–7 years. At school age, more boys than girls (ratio, 3:1) have constipation. This is usually functional (i.e., without objective evidence of a pathological condition). About 80% of children with functional constipation will be successfully treated within 5 years. Success is less likely when constipation first presents before the age of 12 months, or in children with associated fecal soiling.

A significant proportion (30%–50%) of children will relapse after being successfully treated for constipation (with or without soiling) and there is evidence that they do not improve on reaching puberty. About 3% of adults report fewer than three bowel movements a week; up to 20% of women consider themselves to be constipated; and 10%–20% of men and women regularly use laxatives.

NORMAL BOWEL FUNCTION:

In healthy children the number of bowel movements changes with age and diet. Meconeum is passed within the first 24 hours in about 87% of infants and within 48 hours by 99%; this is not influenced by whether the infant is receiving breast milk or formula. Subsequently, however, the method of feeding has a significant impact on stool frequency, color and consistency. Breast-fed infants pass softer, uniformly yellow stools up to five times a day. Many a time passage of small stools after each feeds is normal due to gastro-colic reflex during early infancy. In a few healthy breastfed infants there may be weeks between bowel movements, but the stools are soft. This is more frequent than in bottle-fed infants. Within the first few weeks of life, 64% of breast-fed, but only 30% of bottle-fed, infants are having more than three bowel actions a day. Stool frequency reduces progressively with age, so that by 16 weeks of age both breast-fed and bottle-fed infants are passing on average two stools a day. Weaning, which in most children occurs between 4 and 6 months of age, results in a firmer stool. By around age 4 a child may will have an average one bowel movement a day.

Mean Average Frequency of Bowel Movements (BMs) in Children[1]
Age	BMs per Week*
0 – 3 months	5 – 40 (breast milk)
	5 – 28 (formula)
6 – 12 months	5 – 28
1 – 3 years	4 – 21
4 years	3 – 14
* Approximately means ± 2 SD

HOW TO DEFINE CONSTIPATION?

There is no precise definition of constipation that fits all people. Constipation in children can be defined as the passage of painful stools or a reduction in frequency of stools. An important feature in this definition is the child’s perception of pain or difficulty in passing stool or inability to pass stools without excessive straining– regardless of frequency and a palpable abdominal or rectal fecal mass. Faecal soiling occurring at least once a week and persisting beyond the age of toilet training can also indicate constipation. The experience of pain when evacuating can lead to fear in passing stools and avoidance of having a bowel movement. Thus setting a vicious cycle of impaction, pain, and fear and avoiding the bowel movement.

Nonetheless, it is not correct to assume that a bowel movement every day is “normal.” There is no “right” number of bowel movements. Each person’s body finds its own normal pattern, which depends on many factors. Usually normal bowel pattern is passage of soft, formed, stools of adequate quantity without pain or excessive straining that does not cause any discomfort to child. In general, 2 or less normal bowel movements per week may be a sign of constipation. Fecal soiling is often secondary to constipation and may occur during spontaneous relaxation of sphincter precipitated by rectal distention.

CAUSES OF CONSTIPATION:

Constipation in children may be caused by a change in diet and fluid intake, during toilet training or a deviation from usual toileting routines, or avoidance of bowel movements because of pain such as anal irritation, fissures (small tears in the skin), or rashes. Other factors can play a role in causing painful bowel movements, such as changes in daily routine, environment, stressful events, or postponing using the toilet when the urge is felt. At one time or another, almost everyone is constipated. In most cases, it lasts for a short time and is not serious. By understanding factors that cause constipation, steps can be taken to help prevent it.

Besides these, other pathological causes in children are anal stenosis, anterior ectopic anus (in general low varieties of Anorectal malformation), congenital hypothyroidism, Hirschsprung’s disease, Colonic strictures etc. Children with Down’s syndrome and mental retardation, Cerebral palsy also suffer from constipation due to lack of cortical awareness in such children.

ETIOLOGY OF CONSTIPATION:

The etiology of constipation and soiling in childhood is multifactorial. Painful defecation has been proposed as the primary precipitant of functional fecal retention in early childhood, although the cause of these painful bowel actions is not clear. Functional fecal retention is characterized by voluntary withholding of stool. Childhood constipation appears to be a significant problem in some Western communities, leading to speculation about the roles of diminished fibre intake and reduced exercise. There is certainly evidence that hard bowel movements may precede stool toileting refusal, perhaps leading to a self-perpetuating cycle. Subsequent rectal dilatation is then associated with impaired rectal sensation and motor function (ineffective peristalsis). Fecal soiling is likely to occur during spontaneous relaxation of the sphincters precipitated by rectal distension.

Defecation is a complex process involving a coordinated activity of the abdominal and pelvic musculature (straining) and relaxation of anal sphincters. It is triggered by achieving a threshold distension of the rectum with stool. Once continence has been achieved, defecation can be inhibited by voluntary contraction of the external sphincter. Boys take slightly longer to toilet train than girls, but complete bowel control is achieved at a mean age of 37 months. By pre-school age, 96% of children on a low-fibre diet have a bowel action within the range of three times a day to every alternative day.

In older children, difficulty in evacuating stool may be associated with abnormal contraction of the anal sphincters and pelvic floor during attempted defecation (anismus), which may develop from earlier voluntary withholding behavior. Slowed colonic transit as a cause of constipation in childhood is also well recognized, as is the association of low fibre intake with hard, infrequent stools. Although extreme restrictions of physical activity and reduced fluid intake can be associated with constipation, these are not usually important factors in most children with constipation.

CLINICAL PRESENTATION OF CONSTIPATION:

Constipation in the first week of life, presenting as delayed passage of meconium beyond the first 48 hours, suggests either an anatomical obstruction, such as anal atresia or stenosis, or Hirschsprung’s disease.

In the next few months, before weaning, bottle-fed or formula fed infants tend to pass harder stools and may present with difficult passage of dry, hard stools, and occasionally with a fissure. Breast-fed infants are less likely to pass hard stools, but very infrequent stools in these infants may raise parents’ concern about whether this is normal. Constipation may also first present at the time of weaning onto solids — in both breast-fed and bottle-fed infants.

Toilet training for stool may be associated with the development of withholding behavior and functional fecal retention. Behavioral problems can lead to struggles over toilet training, and the child may start refusing to use the toilet despite being previously successfully trained. They may also exhibit withholding behavior when ambulant, crossing their thighs or walking on tiptoe to clench their buttocks.

Up to 63% of children with constipation and fecal soiling will have a history of painful defecation beginning before 3 years of age and secondary withholding behaviour.21 Parents will typically report a child who strains at stool but can not pass more than a small amount.

Typical description of a child with functional constipation will include following features-

• excessive straining at stools
• urge to pass but cannot pass stools
• crossing of the legs
• never sits to pass stool (lack of toilet training)
• sits in the toilet but stands up in between (due to fear of pain)
• frequent soiling of cloths with small amount of solid stool (incomplete evacuation) or liquidy stools (encopresis)
• dry hard stools with / without blood
• may need manual evacuations at home
• usually have tried various Ayurvedic & other home remedies and laxatives
• faulty dietary patterns
• no history of delayed passage of meconium after birth, enterocolitis, delayed development, anemia and lack of any physical abnormalities

PHYSICAL EXAMINATION AND INVESTIGATIONS:

– Apart from the routine aspects of the physical examination, it is important to determine whether the child’s development is within normal limits for his or her age. A brief nutritional assessment is also useful. Anemia, stunted physical growth & malnutrition are usually associated with Hirschsprung’s disease, while developmental delay is seen in hypothyroidism.

– The physical examination should focus particularly on the abdomen, spine and perineum. The abdominal examination reveals whether there is a significant colonic mass. Of all children with significant constipation, about half will have palpable abdominal stool.22

– A neurological examination should include the spine as well as lower limbs and the saddle area to assess whether sensation and reflexes are normal.

– An anorectal examination enables exclusion of anatomical abnormalities, such as anal stenosis, as well as traumatic injury. It also allows assessment of sphincter tone and the presence of stool. The presence of firm, packed stool in the rectum correlates closely with radiological evidence of fecal retention.

– An abdominal x-ray is only likely to be useful if no significant fecal retention is found on rectal examination.24 There can be considerable inter observer variation among radiologists in scoring x-rays for fecal retention.23 Agreement is more likely with a large amount of retained faeces.

– Barium studies are of little or no value in most children with constipation, as they do not add any further information.

– Anorectal manometry provides an understanding of the pathophysiological abnormalities underlying the child’s constipation. However, it is only available in a few specialized centers. About 95% of children with functional constipation will have an abnormality on manometric examination (e.g., impaired sensation to rectal distension, abnormal contraction of the external anal sphincter and pelvic-floor muscles during straining for defecation, or inability to defecate the rectal balloon).22

– Measurement of colonic transit by radioisotope or radio-opaque marker is useful to differentiate slow-transit constipation from anismus,25 but is of little practical use in most children with functional constipation.

– Blood tests are of limited value, but are useful to confirm that thyroid function and calcium levels are normal. Stool microscopy is of little or no value.

MANAGEMENT OF CHILDREN WITH CONSTIPATION:

Education & Counseling-

It is important to spend time at the initial consultation with both child and parents (especially mother) in order to explain that constipation and fecal soiling are common and are likely to improve with time and simple changes & therapies. Certain facts should be stressed clearly to the parents before starting therapy. Motivation of mother and alleviating their anxiety by answering smallest queries and stigmas is the key to success. Ask them to implement all changes together, keep patience, persist with them for a long time, do not force or abuse the child, continue with laxatives for long time and gradually withdraw the drugs but not the other behavioral changes will be the road to achieve success in such children. Attention to what your child drinks, eats, and how much exercise your child gets, often helps prevent or relieve constipation. Providing guidance to prevent stool withholding, and helping establish regular times for going to the toilet are also important.

The important four components of therapy are….

1) Dietary Modifications

Whole family should change the dietary pattern and should adopt the healthy food habits. One can change the habit by setting an example yourself rather than advising children about good food. Everyone has to resist the pressure from a child in a proper way to implement such change. One should not force or abuse the child to implement such change and simultaneously one has to keep patience and wait for a change to become reality. This is the only way to improve the habits of a child.

a) Eating more fiber

Fibers retain water and makes stool soft & bulky. It is found in many vegetables, fruits, and grains. Be sure to add fiber a little at a time to let the body get used to it slowly. Limit high-fat, high-sugar foods and foods that have little or no fiber such as ice cream, cheese, meat, snacks like chips and pizza, wafers, toast, biscuits and other bakery items made up of refined wheat floor (Mainda), other home made Indian snacks made up of Mainda, processed foods such as instant mashed potatoes or already-prepared frozen dinners.

b) Drinking more fluids

Encourage child to take more fluids. It helps prevent stool from drying out. Liquid helps keep the stool soft and easy to pass, so it is important to drink enough fluids. Avoid liquids that contain caffeine (found in many soft drinks) which tends to dry out the digestive system. It does not mean only water but various liquids should be added in a smarter way like, lemon water, soups, juices, dal, curry, kheer, butter milk, curd and so on. Juices containing sorbitol, such as prune, pear and apple juice can decrease constipation. In infants older than 6 months, however too much fruit juice can cause gastrointestinal and other problems. Be sure to limit its consumption appropriately.

But limit the Milk intake to less than half a liter in 24 hours. As more milk intake prevents child from eating other things due to feeling of satiety and easy to consume.

c) Other food items

One can try some age old home remedies like honey, butter or some medicinal plant extract also. But avoid giving castor oil as it is an irritant purgative. Besides these all other food items can be given provided child avoids certain items listed above and consumes all “good food”. Parents should be cautious about content of food rather than quantity of food to be consumed by child.

d) Other drugs

Be sure to tell the doctor about any prescription and over-the-counter medicines, Including herbal supplements, your child may be taking. Some medications can cause constipation.

2) Toilet Training

Develop a bowel training program for your child. Bowel retraining works by teaching new skills or strategies to develop a routine and predictable schedule for evacuation.

a) Creating cortical awareness about defecation

Right from the age of 6 months one can start and make child toilet trained. Start sitting him on “potty” at fix regular time twice or thrice in a day at fix place. Gradually it becomes like a conditional reflex and that can be continued in during later age in life and this is the easiest way to avoid constipation (i.e. fecal impaction) to occur. Children may delay using the toilet for several reasons, including being in school or busy with activities, but it important to remind them and make them sit daily at fix time to make a habit of it.

It is easy and comfortable to strain and create abdominal pressure in a squatting / sitting position to defecate. So it is imperative for any person to squat/ sit for defecation. Same applies to children also. A child with fecal impaction will avoid sitting or squatting as it is a very painful experience for him to pass dried, hard, big fecal mass. Due to fear of pain child starts avoiding defecation and impaction worsens, thus setting a vicious cycle. Parents need to understand this and should make sincere efforts to teach child how to defecate easily. There are no short cuts to this and no medicine can help you to do this.

b) Allowing enough time to have a bowel movement

It is important not to ignore the urge to have a bowel movement. Waiting only makes constipation worse. Try getting your child up early enough in the morning to give them time to use the bathroom before school. Regular, unhurried time on the toilet after meals, particularly breakfast or dinner, can help.

c) Exercising

Regular exercise helps the digestive system stay active, healthy and toned up. A person does not need to be athletic. Any physical activity will help to initiate bowel movements and peristalsis. Encourage your child to exercise daily.

d) Soiling

The easiest way to explain soiling is to emphasize the loss of conscious awareness of the need to defecate that comes with chronic rectal distension with feces. Episodes of fecal incontinence are likely to be due to involuntary relaxation of the sphincters triggered again by rectal over distension (some thing like overflow incontinence). The emphasis on the importance of “keeping the rectum empty” is likely to alleviate blame, and improve cooperation and compliance.26 If you are successful in keeping the rectum empty, you can get rid of fecal soiling.

3) Medications

Role of medication in the treatment is always supportive. Medications will help to keep stool soft and will ease the passage by lubricating it, thus allowing pain free passage of stool. Relying only on medication without implementing above changes will never be successful. It needs to be continued for long period, weaned off gradually over a long period once normal defecation pattern is achieved. One should not be in a hurry to withdraw drugs.

Children are best treated with a softener such as lactulose (5–15 mL/ day, once to thrice a day). It is like an inert molecule without much side effects even if used over long period. Liquid paraffin should be avoided in infants under the age of 6 months, as well as in those with frequent regurgitation, or when there is concern about aspiration. Hypertonic phosphate enema preparations should be avoided in children because of the risk of significant electrolyte disturbance.26 Besides this, Bisacodyl suppositories can be used to achieve rectal emptying in the initial days till child gets used to all behavioral changes and start passing stools daily.

4) Disimpaction

Severe fecal impaction will stretch the rectal muscles to its fullest, resulting in ineffective peristalsis and inability to evacuate. So before starting therapy complete rectal emptying should be achieved to facilitate defecation.

Children who present with significant fecal retention should have a “complete clean-out” of the colon.26 Softening agents and stimulant laxatives, taken orally, are usually preferred, although there may be some advantage in the concurrent use of enemas. In severe cases, manual evacuation with saline wash outs along with oral medications for few days will help significantly.

On going treatment (Maintenance therapy)-

The crucial aspect of long-term maintenance therapy is establishing a regular toileting regimen, generally about two to three times a day for 5–10 minutes at a time after meals, with the child being praised for complying.

It is important to ensure appropriate toileting posture and comfortable foot support with the feet flat.

Behavioral modification can be documented in a toileting diary, which is used to record toileting frequency (usually with a tick), successful passage of stool in the toilet and soiling-free days (with a star), daily medications, and episodes of soiling. Stool reimpaction is less likely to occur if stools are being passed daily.26

Significant behavioral abnormalities may merit referral for psychological help, although this is best initiated by a pediatrician. Issues that may need to be addressed include parental distress, low self-esteem in the child, and poor adherence to therapeutic regimens. The psychosocial aspects of every child’s problem should be considered and in certain resistant cases one may need a help from a psychologist.30

After establishing regular bowel pattern, medications are weaned gradually but parents should continue with other behavioral changes through out the child’s life, as they are the proper way of avoiding such functional problem at any age of life.

CONCLUSION:

In a functional disorder like this one should rely more on behavioral aspects than only relying on medications. Successful implementation of such changes is a key to success in such cases. As your child gets older, he or she may find it embarrassing to talk about bowel movements. But children need to know that a bowel problem like constipation happens to virtually everyone now and then. Help them make healthy choices. Talk reassuringly and in a matter of fact way about bowel habits. Importantly, recognize the developmental stage of your child and, if necessary, be sure to work with your child’s physician to plan treatment that takes into account the child’s point of view.

DR AMIT SITAPARA
MCh (Ped Surgery)
DNB (Ped Surgery)
Laxmi Children Hospital
Rajkot.
Ph: 0281-2458666

Polyethylene Glycol 3350 Powder for Oral Solution

TABLE OF CONTENTS

1. DESCRIPTION	7. WARNINGS AND PRECAUTIONS
2. INDICATIONS AND USAGE	8. ADVERSE REACTIONS
3. DOSAGE AND ADMINISTRATION	9. OVERDOSAGE
4. CONTRAINDICATIONS	10. DRUG INTERACTIONS
5. MECHANISM OF ACTION	11. PHARMACOKINETICS
6. USE IN SPECIFIC POPULATIONS	12. HOW SUPPLIED/STORAGE AND HANDLING

1. DESCRIPTION

Polyethylene Glycol 3350 Powder for Oral Solution is a synthetic polyglycol having an average molecular weight of 3350. Polyethylene glycol 3350 is an osmotic agent for the treatment of constipation. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups.

Below 55°C, it is a free flowing white powder freely soluble in water.

2. INDICATIONS AND USAGE

For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.

3. DOSAGE AND ADMINISTRATION

The usual dose is 17 grams (about 1 heaping tablespoonful) of powder per day (or as directed by physician) in 4 – 8 ounces of water, juice, soda, coffee, or tea. The dosing cup supplied with each bottle is marked with a measuring line and may be used to measure a single polyethylene glycol 3350 dose of 17 grams (about 1 heaping tablespoonful).

Two to 4 days (48 to 96 hours) may be required to produce a bowel movement.

4. CONTRAINDICATIONS

Polyethylene glycol 3350 is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

5. MECHANISM OF ACTION

Polyethylene glycol 3350 is an osmotic agent which causes water to be retained with the stool. Essentially, complete recovery of polyethylene glycol 3350 was shown in normal subjects without constipation. Attempts at recovery of polyethylene glycol 3350 in constipated patients resulted in incomplete and highly variable recovery.

6. USE IN SPECIFIC POPULATIONS

6.1 Usage in Pregnancy

Pregnancy Category C

It is also not known whether polyethylene glycol 3350 can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Polyethylene glycol 3350 should only be administered to a pregnant woman if clearly needed.

6.2 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.3 Geriatric Use

There is no evidence for special considerations when polyethylene glycol 3350 is administered to elderly patients.

7. WARNINGS AND PRECAUTIONS WARNINGS

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating polyethylene glycol 3350 therapy.

PRECAUTIONS

General: Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel habits.

Polyethylene glycol 3350 should be administered after being dissolved in approximately 4 – 8 ounces of water, juice, soda, coffee, or tea.

8. ADVERSE REACTIONS

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients.

9. OVERDOSAGE

There have been no reports of accidental overdosage. In the event of overdosage, diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

10. DRUG INTERACTIONS

No specific drug interactions have been demonstrated.

11. PHARMACOKINETICS

No pharmakokinetic information is available.

12. HOW SUPPLIED/STORAGE AND HANDLING

1) How Available:

a) Brand name: MIRALAX, by BRAINTREE

b) Generic drugs:

GLYCOLAX, by SCHWARZ PHARMA.

Polyethylene Glycol 3350, by various manufacturers.

2) How Supplied:

Over-the-counters:

MIRALAX (brand name).

GLYCOLAX (generic drug), by KREMERS URBAN DEV.

Polyethylene Glycol 3350 (generic drug), by various manufacturers.

Prescriptions:

GLYCOLAX (generic drug), by SCHWARZ PHARMA.

Polyethylene Glycol (generic drug), by various manufacturers.

In powdered form, for oral administration after dissolution in water, juice, soda, coffee, or tea. GlycoLax (Polyethylene Glycol 3350 Powder for Oral Solution) is available in three package sizes:

16 oz. container of 255 grams of laxative powder (NDC 62175-442-15)

24 oz. container of 527 grams of laxative powder (NDC 62175-442-31)

carton of 14 individual packets containing a single 17 gram dose (NDC 62175-442-14).

3) Storage: Store at 20° – 25°C (68° – 77°F); excursions permitted between 15° – 30°C (59° – 86°F).

Rx and OTC