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IRCT2015043012072N6 IRCT 2015-05-24 Isfahan University of Medical Sciences Ondancetron Effect at Vomiting Control in Head Trauma Comparing the Antiemetic Effects of Ondansetron and Metoclopramide in Patients with Minor Head Trauma 2014-01-01 anticipated 120 Complete https://irct.ir/trial/12207 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 4 Condition 1: head Injuries. Condition 2: head Injuries. Intervention 1: Intervention group treat with ondansetron (4mg/2ml, slow injection). 20 minutes post drug administration, nausea level will measure again. If the severity of nausea not decrease at least by 20 mm compared to the rate before the treatment intervention, a rescue dose (4mg ondansetron) would be prescribed for the patient. Intervention 2: Cotrol group treat with metoclopramide (10mg/2ml, slow injection) and treatment with ondansetron (4mg/2ml, slow injection). 20 minutes post drug administration, nausea level will measure again.
public Mehrdad Esmailian
Azadi Ave.
Isfahan Iran (Islamic Republic of) +98 31 3629 3482 m_esmailian@med.mui.ac.ir Isfahan University of Medical Sciences scientific Mehrdad Esmailian
Azadi Ave.
Isfahan Iran (Islamic Republic of) +98 31 3629 3482 m_esmailian@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria : minor head trauma; nausea and vomiting; and a triage level of 3 or higher based on emergency severity score; exclusion criteria : hemodynamic instability; pregnancy/lactation; any neurologic deficit; restlessleg syndrome; alcohol usage; consumption of any antiemetic drugs during the 8 hours prior to admission; chemotherapy or radiotherapy; inability to complete and understand study explanations or outcome measures; allergy or previous adverse reactions to metoclopramide or ondansetron; 15 years 139 years Both S06.9 S09.9 Intracranial injury, unspecified Unspecified injury of head Treatment - Drugs Treatment - Drugs Intervention group treat with ondansetron (4mg/2ml, slow injection). 20 minutes post drug administration, nausea level will measure again. If the severity of nausea not decrease at least by 20 mm compared to the rate before the treatment intervention, a rescue dose (4mg ondansetron) would be prescribed for the patient. Cotrol group treat with metoclopramide (10mg/2ml, slow injection) and treatment with ondansetron (4mg/2ml, slow injection). 20 minutes post drug administration, nausea level will measure again. Nausea Severity. Timepoint: before drug injection and 20 minutes after drug injection. Method of measurement: Visual Analogue Scale. Dystonia. Timepoint: before drug injection and 20 minutes after drug injection. Method of measurement: Physical Examination. Fatigue. Timepoint: before drug injection and 20 minutes after drug injection. Method of measurement: Physical Examination. Headache. Timepoint: before drug injection and 20 minutes after drug injection. Method of measurement: Visual AnalogueScale. Isfahan University of Medical Sciences Approved 2013-08-06 Isfahan University of Medical Sciences Azadi Ave. Isfahan Iran (Islamic Republic of)