Etomidate causes pain when injected intravenously during induction of anesthesia. In this study we sought to determine if pretreatment by ondansetron reduces the pain on injection of etomidate.
20 patients of both sexes aged between 18 to 50 years of American Society of Anesthesiologists(ASA) physical status class I or II, whom were candidates for various elective surgical procedures requiring more than one intravenous access are enrolled in the study. On arrival to the operating room two 22 gauge cannulas are inserted into veins on the dorsum of both hands. Following the infusion of 100 mL normal saline into both hands, using an elastic band, venous drainage of hands are occluded at midarm. The patients are administered 8mg (2 mL)of ondansetron from one hand and 2ml of 0.9% saline from the other hand at the same time. The elastic band is removed after 1 minute and 2mg(1 mL) of etomidate is administered at the same rate simulataneously at both hands. The patients are asked to give a score of pain based on a verbal analogue scale (VAS) to each hand.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106125140N4
Registration date:2012-09-25, 1391/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-25, 1391/07/04
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-07-31, 1391/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ondansetron on injection pain caused by Etomidate
Public title
Pain on Injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Society of Anesthesiologists(ASA) physical status class I or II. Exclusion Criteria: patients with a history of thrombophebitis or vascular disease; chronic pain; diabetes mellitus; history of tumors or burns in either hands; history of addiction; any contraindications to injection of ondansetron or etomidate.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee, Faculty of Medicine of Tehran university of Medical Sciences
Street address
Second floor, Faculty of Medicine, Tehran University of Medical Sciences and Health Services
City
Tehran
Postal code
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
90/3451
Health conditions studied
1
Description of health condition studied
pain prevented in healthy subjects after injection
ICD-10 code
T80.9
ICD-10 code description
Unspecified complication following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Pain
Timepoint
2 minutes after injection
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
urticaria
Timepoint
30 minutes after ondansetron
Method of measurement
documenting any urticaria on thorax and around the neck
Intervention groups
1
Description
Intervention:. 8mg (2 mL) of ondansetron was administered from one hand.
Category
Prevention
2
Description
Control: 2ml of 0.9% saline from the other hand at the same time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoondzadeh
Street address
Vice Chancellor for research , Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Department of Anesthesiology, Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, North Karegar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Omid Azimaraghi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)