Nausea and vomiting are the most common complications after minor head trauma that increases the risk of intracranial pressure rising. This controlled, randomize, double blind clinical trial, will conduct in emergency department of Alzahra Hospital. The patients older than 15 years old with minor head trauma associated with nausea and vomiting will be randomly divided into 2 groups: treatment with metoclopramide (10mg/2ml, slow injection) and treatment with ondansetron (4mg/2ml, slow injection). The comparison between the 2 groups will be done regarding antiemetic efficacy and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015043012072N6
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Mehrdad Esmailian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3482
Email address
m_esmailian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-06-30, 1393/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Antiemetic Effects of Ondansetron and Metoclopramide
in Patients with Minor Head Trauma
Public title
Ondancetron Effect at Vomiting Control in Head Trauma
Purpose
Treatment
Inclusion/Exclusion criteria
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;
Age
From 15 years old to 139 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Azadi Ave.
City
Isfahan
Postal code
Approval date
2013-08-06, 1392/05/15
Ethics committee reference number
65489
Health conditions studied
1
Description of health condition studied
head Injuries
ICD-10 code
S06.9
ICD-10 code description
Intracranial injury, unspecified
2
Description of health condition studied
head Injuries
ICD-10 code
S09.9
ICD-10 code description
Unspecified injury of head
Primary outcomes
1
Description
Nausea Severity
Timepoint
before drug injection and 20 minutes after drug injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Dystonia
Timepoint
before drug injection and 20 minutes after drug injection
Method of measurement
Physical Examination
2
Description
Fatigue
Timepoint
before drug injection and 20 minutes after drug injection
Method of measurement
Physical Examination
3
Description
Headache
Timepoint
before drug injection and 20 minutes after drug injection
Method of measurement
Visual AnalogueScale
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehrdad Esmailian
Street address
Sofeh Blv.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Azizkhani
Street address
Azadi Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 3629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 3629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Azadi ave.
City
Isfahan
Postal code
Phone
+98 31 3629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)