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IRCT201601213449N20 IRCT 2016-02-08 Vice Chancellor for Research, Tehran University of Medical Sciences Metoclopramide and enteral nutrition Comparing efficacy and safety of metoclopramide as continuous intravenous infusion and intravenous bolus injection on enteral nutrition tolerance in critically ill patients 2015-09-21 anticipated 40 Complete https://irct.ir/trial/3553 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive. 3 Gastroparesis. Intervention 1: Intervention group: Metoclopramide infusion with rate of 40mg/24-hour for 7 days. Intervention 2: Control group: Metoclopramide intravenous injection with dose of 10 mg every 6 hours for 7 days.
public Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6119 2112 khalilih@tums.ac.ir Tehran University of Medical Sciences scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6119 2112 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Critically ill adult patients who are candidate to receive metoclopramide as prokinetic agent due to enteral feeding intolerance (defined as gastric residual volume equal to or greater than 250 ml concomitant with symptoms of nausea, vomiting, and regurgitation or gastric residual volume more than 500 ml during 24 hours of enteral feeding) will be included. Exclusion criteria: Patients with metoclopramide allergy; metoclopramide intolerance; uncontrolled ventricular arrhythmia; extrapyramidal reactions; seizure; head trauma; signs and symptoms of increased intracranial pressure 18 years 65 years Both K90.4 Malabsorption due to intolerance, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Metoclopramide infusion with rate of 40mg/24-hour for 7 days Control group: Metoclopramide intravenous injection with dose of 10 mg every 6 hours for 7 days. Enteral feeding intolerance. Timepoint: Daily. Method of measurement: Gastric residual will be measured between the enteral feeding intervals. Intolerance defined as gastric residual volume more than 250 ml with clinical symptoms or gastric residual volume more than 500 ml by itself. Metoclopramide side effects. Timepoint: Daily. Method of measurement: Patients will be monitored regarding metoclopramide related adverse reactions including cardiovascular (blood pressure and cardiac rhythm), neurological (extrapyramidal signs and seizure) and gastrointestinal (diarrhea). Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2015-09-16 Research Ethics Committee of Tehran University of Medical Sciences 4th floor, No. 23, Poursina Street, Keshavarz Blvd., Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)