Introduction: This study aims to compare the effect of Ondansetron and Metoclopramide on nausea/vomiting in patients with head trauma referred to Imam Hossein Hospital. Design: Randomized, double-blind controlled trial. Method: The total number of 130 patients are involved who are randomly divided into two groups of 65. They recieve Metoclopramide, 10 mg or Ondansetron, 4 mg. Nausea/vomiting in patients is evaluated by a VAS (Visual Analogue Scale) self score after 20 minutes. Need for repeated dose of drug and any adverse event is also recorded. Inclusion criteria: Patients with head trauma and nausea or vomiting who require anti emetic injection with GCS >=13; age over 15; without metabolic and gastrointestinal disease. Exclusion criteria: Hemodynamic instability; Pregnancy, Breast feeding, Alcohol use; Chemotherapy or radiation therapy; Prior use of antiemetics within 8 hours; Opioid use; Prior intravenous fluid administration; Vertigo; Allergy to study drugs; Neurologic deficit. Main outcome measure: Nausea or vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010231731N1
Registration date:2017-01-21, 1395/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-21, 1395/11/02
Registrant information
Name
Hosein Partovinejad
Name of organization / entity
Imam Hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 73430
Email address
biglari-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Ondansetron and Metoclopramide in Treatment of Nausea and Vomiting in Head Trauma Patients
Public title
Treatment of Nausea and Vomiting in Head Trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: History of head trauma; Presence of nausea or vomiting; Triage level of 3 or more; GCS >=13, age over 15.
Exclusion criteria: Unstable hemodynamics; Pregnancy or breast feeding; Neurologic deficit; Restless leg syndrome; Alcoholism; Prior use of antiemetics within 8 hours; Opioid use; Prior intravenous fluid administration; Vertigo; Chemotherapy; Radiotherapy; History of allergy or adverse reaction to metoclopramide or ondansetron; inability to complete trial or record outcomes.
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
130
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 Shahid Beheshti University of Medical Sciences
Street address
Faculty of medicine, Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Postal code
1985717434
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
IR.SBMU.SM.REC.1394.209
Health conditions studied
1
Description of health condition studied
Head Trauma
ICD-10 code
S00
ICD-10 code description
Superficial injury of head
Primary outcomes
1
Description
Nausea / Vomiting
Timepoint
Before and 20 minutes after injection
Method of measurement
VAS score (visual analog scale)
Secondary outcomes
1
Description
Drug adverse effect including extrapyramidal effects, dyskinesia
Timepoint
at discharge
Method of measurement
clinical exam
2
Description
Need for repeating injection
Timepoint
20 minutes after first injection
Method of measurement
VAS score (Visual Analog Scale)
Intervention groups
1
Description
Intervention group 1: Intravenous Metoclopramide, 10 mg/2ml once injection
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous Ondansetron, 4mg/2ml, Once injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Hosein Partovinejad
Street address
Madani st., Nezam Abad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ziaei
Street address
3rd floor, Faculty of medicine, Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Grant name
Grant code / Reference number
113
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosein Partovinejad
Position
Resident of emergency medicine
Other areas of specialty/work
Street address
Imam hossein Hospital, Madani st.
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
biglari-m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Biglari
Position
Attending physician internal medicine
Other areas of specialty/work
Street address
Imam Hossein Hospital, Madani St., Nezam Abad
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
biglari-m@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosein Partovinejad
Position
Resident of emergency medicine
Other areas of specialty/work
Street address
Imam Hosseion Hospital, Madani St., Nezam Abad
City
Tehran
Postal code
Phone
+98 21 73430
Fax
Email
biglari-m@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)