The purpose of this study was to investigate the effect of Celecoxib on post operative pain. A total of 80 patients with leg fracture and ASA class 1 or 2 were randomly assigned to receive 200 mg Celecoxib or placebo 2 hours before operation. VAS score was checked in 2, 6, 12, and 24 hours after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010284947N2
Registration date:2010-11-22, 1389/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-22, 1389/09/01
Registrant information
Name
Mohammad Mahdi Dadras
Name of organization / entity
Zahedan University of Medical Siences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 1260
Email address
dadras@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preemptive celecoxib on pain score reduction and opioid consumption following lower extremity Surgery
Public title
Effect of celecoxib on post operative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 50 years old, ASA class 1 or 2
Exclusion criteria: weight less than 40 or higher than 100 kg, opium addiction, history of MI, peptic ulcer, renal failure, Aspirin allergy, lithium usage, psychiatric disorder
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Vice-chancellor for Research and Information Technology of Zahedan University of Medical Sciences an
Street address
Zahedan University of Medical Sciences and Health Services
City
Zahedan
Postal code
Approval date
2010-06-17, 1389/03/27
Ethics committee reference number
83-1241
Health conditions studied
1
Description of health condition studied
fracture of leg
ICD-10 code
T12
ICD-10 code description
Broken leg NOS
Primary outcomes
1
Description
Pain intensity
Timepoint
in 2 and 6 and 12 and 24 houres after operation
Method of measurement
VAS score
Secondary outcomes
1
Description
opioid consumption
Timepoint
24 hr after operation
Method of measurement
Medical records
Intervention groups
1
Description
Celecoxib 200mg, orally, 2 hours before operation
Category
Treatment - Drugs
2
Description
Placebo, orally, 2 hours before operation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Mohammad Mahdi Dadras
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Dr Masum Khoshfetrat
Street address
Ali Ebn Abitaleb Hospital
City
Zahedan
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 and Health Services
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
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Mahdi Dadras
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital-
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
dadras@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Masum Khoshfetrat
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Ali Ebn Abitaleb Hospital
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
dadras@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)