CTRI/2024/03/063855
Not Yet Recruiting
Phase 4
Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial - NI
Institute of Medical sciences (IMS) and SUM Hospitalk0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: K590- Constipation
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K590- Constipation
- Sponsor
- Institute of Medical sciences (IMS) and SUM Hospitalk
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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