Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction

Launched by INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL · Mar 30, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two types of laxatives—PEG 4000 and PEG 3350 with electrolytes—used to help children aged 1 to 16 years who are suffering from constipation and fecal impaction. Constipation in children is common and often results from functional issues, meaning there’s no underlying medical problem. The trial aims to see which of these two treatments is more effective and easier for kids to take. Both treatments will be given for six days or until the child feels better, whichever comes first.

To participate, children must be between 1 and 16 years old and diagnosed with functional constipation, which means they have difficulty passing stools. They should have a hard stool mass that can be felt in their abdomen or excessive stool visible in their colon. However, children with certain medical conditions or previous surgeries affecting their digestive system won't be eligible. Throughout the trial, researchers will monitor how well each treatment works, how long it takes for relief, and whether kids have any trouble with the taste of the laxatives. This information will help doctors understand which treatment might be better for managing constipation in children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 1-16 years age admitted to the inpatient department 2. Having h/o functional constipation as per ROME IV criteria 3)with Fecal impaction defined as A hard mass in the lower abdomen identified on physical examination or Dilated rectum filled with large amount of stool on per rectal Examination or Excessive stool in the colon on abdominal radiography as determined by a radiologist
• Exclusion Criteria:
• • 1. Patients with drug-induced constipation
• • 2. Organic constipation ie, I.Neurological disorders eg. Neural tube defects/cerebral/motor neuron diseases/neuro regression syndromes II.Hirschsprung disease, or anal anomalies III.Known metabolic or endocrine disorders
• • 3. Patients with previous gastrointestinal surgery (except appendectomy)
• • 4. Children with suspected gastrointestinal obstruction
• • 5. Patients taking PEG (either at the time of enrolment or within 2 month before enrolment)
• • 6. Patients receiving medication at enrolment or within 1 month before enrolment influencing gastrointestinal motility function (eg, lactulose, loperamide, cisapride)
• • 7. Known history of Allergy to PEG formulations
• • 8. Patients having comorbidity of any other system like CVS/Respiratory/CNS etc
• • 9. Known case of Chronic kidney disease or history of acute kidney injury in past 3 monthes