Protocol summary

Summary
Goal: Comparison of Metoclopramide and Dexamethasone versus Metoclopramide alone in the control of vomiting due to minor head trauma in the children age range of 2-8 years old. Inclusion criteria: Patients with GCS 14-15; 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; having contraindications for dexamethasone; simultaneous treatment with corticosteroids; diarrhea and a child who is under treatment with sedative drugs. This study will be done as a double-blind randomized controlled trial. We will recruit 60 patients, which has nausea and vomiting followed by minor head trauma, which were referred to the hospital. Twenty minutes before intervention, consciousness of patients and the severity of vomiting, will be recorded based on Visual Analog Scale. This test is a criterion for measuring the intensity of vomiting. A group of patients will receive 0.15 mg/kg Intramuscular injection of Metoclopramide and 0.15 mg/kg intramuscular Dexamethasone; and the other group will receive 0.15 mg/kg intramuscular Metoclopramide and 0.15 mg/kg intramuscular distilled water (placebo). Then, after 20, 40 and 60 minutes, and then every hour up to four hours after intervention the vital signs including (respiratory rate, heart rate,…) and their level of consciousness and also the variations and severity of vomiting will be recorded and will be checked by phone call. Finally, the differences between the two groups will be examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081128944N1
Registration date: 2016-08-11, 1395/05/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-11, 1395/05/21
Registrant information
Name
Seyed Mohammad Kazem Mortazavi
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
mortazavi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2016-07-26, 1395/05/05
Expected recruitment end date
2016-12-25, 1395/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.AJUMS.REC.1395.188

Health conditions studied

1

Description of health condition studied
vomiting caused by minor head trauma
ICD-10 code
F50.5
ICD-10 code description
Vomiting associated with other psychological disturbances

Primary outcomes

1

Description
vomiting caused by minor head trauma
Timepoint
20 minutes before the Intervention
Method of measurement
VAS test

Secondary outcomes

1

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Seyed Mohammad Kazem Mortazavi
Street address
Golestan Hospital, Golestan Ave
City
Ahvaz

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyed Mohammad Kazem Mortazavi
Street address
Imam Khomeini Hospital, Sharifzadeh st. Azadegan Ave.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mr. Dianat
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mahdis vakili
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
mahdisvakili@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Seyed Mohammad Kazem Mortazavis
Position
Resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
eltemas2a1000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mahdis Vakili
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
+98 61 3336 7543
Email
eltemas2a1000@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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