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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

Comparision of erythromycin vs metoclopramide for gastric feeding intolerance in traumatic brain injury, randomized double blinded placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006111
Enrollment
120
Registered
2015-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- head injury

Interventions

Intervention1: erythromycin and metoclopramide group: erythromycin group will receive Crushed tablet erythromycin 250 mg through RT every 8 hrly for 3 days. Metoclopramide group will receive crushed t

Sponsors

Post Graduate Institue of Medical education research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age >= 18 years of age of either gender -Admission to trauma ICU within 72 hours of head injury -GCS >= 5

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactJeetinder Makkar

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

nscjk2006@gmail.com7087009510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026