The evaluation of effect of ondansetron and dexamethasone combination versus ondansetron alone on treatment of nausea and vomiting in patient with minor head trauma
Assessing the effect of ondansetron and dexamethasone combination versus ondansetron alone on treatment of nausea and vomiting in patient with minor head trauma
Design
A double-blind, randomized, double-blind, With two parallel groups case-control trial with a total of 64 patients referred to Khatam Hospital in year 98.
Settings and conduct
Initially, 64 patients with mild head trauma referred to Khatam hospital were randomly divided into two groups of control and case groups with use of blocked random numbers table. Therapist received two pre-filled syringes at the time of administration of the medication and therapist was unaware of the medication type. Patients in the control group received dexamethasone and ondansetron and in the case group patients received placebo and ondansetron .
Participants/Inclusion and exclusion criteria
The patients with head trauma and vomiting with GCS>14 that dont have shock signes and unstability.
Intervention groups
1. In the case group, the effect of ondansetron alone without dexamethasone(with placebo) on patients with mild head injury was evaluated
2.In the control group, the effect of ondansetron plus dexamethasone on mild head trauma patients in this group was evaluated.
Main outcome variables
Treatment of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045526N1
Registration date:2020-04-12, 1399/01/24
Registration timing:retrospective
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Gholamreza Kargar shoraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3833 3549
Email address
kargar98@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of ondansetron and dexamethasone combination versus ondansetron alone on treatment of nausea and vomiting in patient with minor head trauma
Public title
Effect of ondansetron alone on brain contusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Head trauma with GCS>14
Head trauma with vomiting
Exclusion criteria:
Patients with shock signes
patients with gastrointestinal disease causing nausea
Age
From 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with four blocks, case group (A) and control group (B). Blocks list and numbers (1-6) are assigned to them.Then random numbers are used to determine the order of the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The therapist used pre-prepared medications without knowing what the medication was.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan Univercity of Medical Sciences
Street address
No1, Jame Jam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98157733169
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.ZAUMS.REC.1397.157
Health conditions studied
1
Description of health condition studied
Minor head trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausa vomiting treatment
Timepoint
15 30 60 minutes after drug injection
Method of measurement
Patient evaluation in times15 30 60 minutes after drug
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ondansetron plus placebo group. In this group patients once received ondansetron 4mg plus placebo and then after one hour, patients were examined for nausea or vomiting.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients were given ondansetron 4mg and dexamethasone 10mg and then patients were evaluated for nausea.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Hospital
Full name of responsible person
Dr.Gholamreza Kargar
Street address
No1,Jamejam Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 3001
Email
Kargar98@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Kargar
Street address
No1,Jamejam Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98157733169
Phone
+98 54 3322 3001
Email
Kargar98@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Kargar
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No1 Jamejam Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
0098 54 3223001
Email
Kargar98@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Kargar
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No1,Jamejam Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3223001
Email
Kargar98@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Kargar
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No1 Jamejam Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3223001
Email
Kargar98@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available