Comparison the antiemetic effect of metoclopramide and ondansetron in patients with minor head trauma referred to Shahid Hasheminezhad Hospital
Design
In this randomized controlled clinical trial 180 patients with minor head trauma will be divided in to three groups with sealed envelope.
Settings and conduct
This this randomized controlled clinical trial will be conducted in eme reza hospital emergency department. Participant, Outcome assessor, Data analyser will be unaware of intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria are patients with minor head trauma suffer from nausea and vomiting with normal brain CT scan, GCS=15 and head trauma in the first 24 hours will be enrolled the study. patients will be excluded from study whom have multiple trauma, chronic disease, hypersensitivity to metoclopramide and ondansetron.
Intervention groups
10 mg metoclopramide
4 mg ondansetron
4 ml normal saline
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034403N3
Registration date:2018-04-15, 1397/01/26
Registration timing:registered_while_recruiting
Last update:2018-04-15, 1397/01/26
Update count:0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Hamideh Feiz Disfani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
feyzh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the antiemetic effect of metoclopramide and ondansetron in patients with minor head trauma
Public title
Comparison the antiemetic effect of metoclopramide and ondansetron in patients with minor head trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
minor head trauma with nausea and vomiting
normal brain CT scan
GCS=15
head trauma in the first 24 hours
Exclusion criteria:
multiple trauma
chronic disease
hypersensitivity to metoclopramide and ondansetron
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
information about intervention groups will be saved in sealed envelops and researcher will select one envelope for each patient accidentally.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant, Outcome assessor physician,Data analysts will be unaware of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1234568
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
IR.MUMS.fm.REC.1395.642
Health conditions studied
1
Description of health condition studied
Minor head trauma
ICD-10 code
S06.0
ICD-10 code description
Commotio cerebri
Primary outcomes
1
Description
decrease in nausea and vomiting
Timepoint
befor drug administration, 15 and 30 minutes after drug administration