Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Polyethylene glycol (PEG)4000 ARM [PEG 4000 ARM]: PEG 4000 will be administered at a dose of 1.5 gm/kg/day dissolved in water until resolution of fecal impaction or a maximum till 6 day
Sponsors
Institute of Medical sciences (IMS) and SUM Hospitalk
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving fecal disimpaction in Each Arm Timepoint: 6 days from allocation of treatment or resolution of fecal impaction whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Total no of Days required to achieve fecal disimpaction in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier;Cumulative PEG dose required for fecal disimpaction in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier;Proportion of subjects reporting palatability issues in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is eariler;Proportion of subjects discontinuing the treatment due to palatability issues in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier | — |
Countries
India
Contacts
Public ContactDr Kalpana Panda
Institute of Medical Sciences (IMS) and SUM Hospital
Outcome results
None listed