Objectives: Objective of this study was to compare the effect of Ondansetron, Metoclopramide and Dexamethasone on nausea in patients with mild head trauma referred to Rasht Poursina Hospital.
Design: The study design was randomized, double-blind and uncontrolled with placebo.
Setting and conduct: The total number of patients was 102, who were divided into three groups of 34. They were injected with Metoclopramide, or Ondansetron and Dexamethasone. Nausea in these patients was evaluated by a nurse before drug injection based on the scoring criteria VAS (Visual Analogue Scale), then the medication was injected and after an hour, the nausea was re-evaluated. Patient's satisfaction score was 0 to 4. The number of the most common side effects for each drug was checked.
Participants including major eligibility criteria: Patients with mild head trauma (without trauma in other body parts) and nausea that required injection with GCS arrival=15; age over 18 to 60 years; without metabolic and gastrointestinal diseases were included in the study. Patients with history of brain; internal and systemic disease; hemodynamic instability; pregnancy, alcohol use; chemotherapy or radiation therapy; pathological disorder and brain injury on CT scan were excluded.
Intervention: Patients were injected with Metoclopramide, or Ondansetron and Dexamethasone.
main outcome measures (variables): Nausea
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605087369N4
Registration date:2016-06-05, 1395/03/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Firouz Behboudi
Name of organization / entity
Gilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8773
Email address
info@gtrc.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Ondansetron, Metoclopramide and Dexamethasone on Nausea in Patients with Mild Head Trauma Referred to Rasht Poursina Hospital
Public title
Comparing the effect of Ondansetron, Metoclopramide and Dexamethasone on nausea in patients with mild head trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with mild head trauma and nausea that requires injection; with arrival GCS=15; age over 18 years to 60 years; the absence of metabolic and gastrointestinal diseases; only with head trauma؛ without other traumas
Exclusion Criteria: Patients with history of brain; internal and systemic disease which mainly consists metabolic disorder such as kidney; liver and endocrine diseases; connective tissue diseases; vacuities and infectious diseases; hemodynamic instability; pregnancy; alcohol use; chemotherapy or radiation therapy; pathological disorder and brain injury on CT scan
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences,West Shahid Beheshti Blv, in front of Bank Sepah, Top floor of Iran Radiator agency, Rasht, Iran
City
Rasht
Postal code
Approval date
2016-02-02, 1394/11/13
Ethics committee reference number
IR.GUMS.REC.1394.452
Health conditions studied
1
Description of health condition studied
Mild head trauma
ICD-10 code
S00
ICD-10 code description
Superficial injury of head
Primary outcomes
1
Description
Nausea
Timepoint
Before and one hour after injection
Method of measurement
VAS scoring (Visual Analogue Scale)
Secondary outcomes
1
Description
Drug side effects
Timepoint
At discharg
Method of measurement
Clinical diagnosis
2
Description
Patient satisfaction
Timepoint
At discharg
Method of measurement
Questionnaire
Intervention groups
1
Description
Intravenous Ondansetron
Category
Treatment - Drugs
2
Description
Intravenous Metoclopramide
Category
Treatment - Drugs
3
Description
Intravenous Dexamethasone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Rojin Jalal Safari
Street address
Rasht Poursina Hospital, Namjoo St, Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences,West Shahid Beheshti Blv, in front of Bank Sepah, Top floor of Iran Radiator agency, Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Rojin Jalal Safari
Position
Medical student
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3336 8773
Fax
Email
rojin_js@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Behzad Zohrevandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
City
Rasht
Postal code
Phone
+98 133368773
Fax
Email
bzohrevandi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Rojin Jalal Safari
Position
Medical Student
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, University of Guilan, 6 Km after Rasht-Tehran Highway, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13333368773
Fax
Email
rojin_js@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)