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IRCT2016081128944N1 IRCT 2016-08-11 Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran Compare the efficacy of Metoclopramide and Dexamethasone with Metoclopramide itself in the control of vomiting due to mild head trauma in children between the ages of 8-2 years Comparison of Metoclopramide and Dexamethasone versus Metoclopramide itself in the control of vomiting due to minor head trauma in the age range of 2-8 years old 2016-07-26 anticipated 60 Complete https://irct.ir/trial/23368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A vomiting caused by minor head trauma. Intervention 1: The intervention group In this study, one group of patients will receive 0.15mg/kg Metoclopramide and also 0.15 mg/kg Dexamethazone intramuscularly. Then, after 20,40 and 60 minutes, and also each hour (until 4 hours after the intervention) the patients' vital signs including ( blood pressure, respiratory rate, heart rate, blood oxygen concentration), the consciousness level of patients and vomiting intensity changes will be measured and recorded. If the patient is discharged from the hospital, he/she will receive a phone call for follow for up to 24 hours. Finally, the differences in these parameters between the two groups will be examined. If the both groups will not respond to the therapeutic intervention or they have deterioration in general condition, other lines of treatment or repetition of the intervention should be considered. If it will happen before the first 20 minutes after intervention, she/he will be excluded. The data from the assessment will be analyzed by SPSS software version 22. Intervention 2: Control group: In this study, this group will receive 0.15mg/kg Metoclopramide and also, 0.15mg/kg distilled water (Placebo) intramuscular. Then, after 20, 40 and 60 minutes, and also each hour (until 4 hours after intervention) the vital signs of patients including ( blood pressure, respiratory rate, heart rate, blood oxygen concentration) , the consciousness of patients and vomiting intensity changes will be measured and recorded. If the patient is discharged from the hospital, he/she will have a telephone call for follow up until 24 hours. Finally, the differences in these parameters between the two groups will be examined. If the both groups had not an appropriate response to the therapeutic intervention, and if their general condition will be deteriorate, other lines of treatment or repetition of the intervention will be done. If patients need other treatment before 20 minute, they will be excluded from the study. The data from the assessment will be analyzed by SPSS software version 22.
public Mahdis vakili
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
Ahvaz Iran (Islamic Republic of) +98 61 3336 7543 mahdisvakili@yahoo.com Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran scientific Seyed Mohammad Kazem Mortazavis
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
Ahvaz Iran (Islamic Republic of) +98 61 3336 7543 eltemas2a1000@yahoo.com Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Patients with GCS 14-15; aged between 2-8 years; minor trauma associated with vomiting and normal CT. Exclusion criteria: unstable hemodynamics; neurological disorders; restless leg syndrome; the use of antiemetic medications during past 8 hours; recent receipt of injectable drugs; Nausea and vomiting caused by motion sickness; chemotherapy and radiotherapy; allergy to metoclopramide or dexamethasone; having contraindications for dexamethasone; simultaneous treatment with corticosteroids; diarrhea and a child who is under treatment with sedative drugs. 2 years 6 years Both F50.5 Vomiting associated with other psychological disturbances Treatment - Drugs Treatment - Drugs The intervention group In this study, one group of patients will receive 0.15mg/kg Metoclopramide and also 0.15 mg/kg Dexamethazone intramuscularly. Then, after 20,40 and 60 minutes, and also each hour (until 4 hours after the intervention) the patients' vital signs including ( blood pressure, respiratory rate, heart rate, blood oxygen concentration), the consciousness level of patients and vomiting intensity changes will be measured and recorded. If the patient is discharged from the hospital, he/she will receive a phone call for follow for up to 24 hours. Finally, the differences in these parameters between the two groups will be examined. If the both groups will not respond to the therapeutic intervention or they have deterioration in general condition, other lines of treatment or repetition of the intervention should be considered. If it will happen before the first 20 minutes after intervention, she/he will be excluded. The data from the assessment will be analyzed by SPSS software version 22. Control group: In this study, this group will receive 0.15mg/kg Metoclopramide and also, 0.15mg/kg distilled water (Placebo) intramuscular. Then, after 20, 40 and 60 minutes, and also each hour (until 4 hours after intervention) the vital signs of patients including ( blood pressure, respiratory rate, heart rate, blood oxygen concentration) , the consciousness of patients and vomiting intensity changes will be measured and recorded. If the patient is discharged from the hospital, he/she will have a telephone call for follow up until 24 hours. Finally, the differences in these parameters between the two groups will be examined. If the both groups had not an appropriate response to the therapeutic intervention, and if their general condition will be deteriorate, other lines of treatment or repetition of the intervention will be done. If patients need other treatment before 20 minute, they will be excluded from the study. The data from the assessment will be analyzed by SPSS software version 22. Vomiting caused by minor head trauma. Timepoint: 20 minutes before the Intervention. Method of measurement: VAS test. Vital signs (respiratory rate, heart rate) and their alertness. Timepoint: after 20,40 and 60 minutes, and also hourly (until 4 hours after the intervention of patients' vital signs). Method of measurement: Pulse Oximeter, manometer, counting the respiratory rate. Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran Approved 2016-06-14 Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave. Ahvaz Iran (Islamic Republic of)