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Clinical trial to compare the efficacy of two oral prokinetics metoclopramide and erythromycin in non acceptance of feed in head injury patient

Phase 3
Completed
Conditions
Health Condition 1: null- head injury
Registration Number
CTRI/2015/08/006111
Lead Sponsor
Post Graduate Institue of Medical education research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

Age >= 18 years of age of either gender

-Admission to trauma ICU within 72 hours of head injury

-GCS >= 5

Exclusion Criteria

•Patient with blunt trauma abdomen.

•Severe thoracic injury with associated hemothorax.

•Allergy to macrolide or metoclopramide.

•Patient taking erythromycin or metoclopramide or drugs that interact with them such as carbamazepinem digoxin, cyclosporein, fluconazole etc.

•Malabsorptive gastrointestinal diseases (obstruction, perforation, short bowel syndrome, or Crohnâ??s disease)

•Abnormal liver function (defined by the presence of 2 of the following: transaminases -3 times the upper limit of normal or total bilirubin -3 times the upper limit of normal, or prothrombin time -2 times the upper limit of normal).

•Renal dysfunction requiring active renal replacement therapy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of the study will be the incidence of high GAV with the use of prokinetic drugsTimepoint: every 4 hrly for 5 days
Secondary Outcome Measures
NameTimeMethod
Any episode of diarrhea or abdominal distensionTimepoint: every 4 hrly for 5 days;daily gastric volume emptiedTimepoint: daily for 5 days;Enteral Feeding failureTimepoint: every 4 hrly for 5 days;percentage of target calorie requirement metTimepoint: daily for 5 days
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