Objectives: To assess the effect of celecoxib and ibuprofen versus placebo on pain after laparotomy in drug dependence.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible drug dependence who are candidate for laparotomy and will refer to Beasat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 60 years; (b) candidate for laparotomy; (c) drug dependence.
Exclusion criteria: (a) using analgesic during 8 hours before surgery; (b) during pregnancy of breastfeeding; (c) sensitivity to celecoxib, ibuprofen, or vitamin B; (d) affected with cardiovascular diseases, renal diseases, liver diseases, and gastrointestinal diseases; (e) alcohol abuse.
Intervention: (a) 200 mg oral celecoxib single dose 1 hour before surgery; (b) 400 mg oral ibuprofen single dose 1 hour before surgery.
Control: one tablet vitamin B single dose 1 hour before surgery.
Primary outcome: measuring the pain severity 1 and 6 hours after surgery using VAS scale.
Secondary outcome: number of narcotic or analgesic used during the 6 hours after surgery by checking medical record.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411269014N50
Registration date:2014-12-02, 1393/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-02, 1393/09/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of celecoxib and ibuprofen versus placebo on pain after laparotomy in drug dependence: a double-blind randomized clinical trial
Public title
Effect of celecoxib and ibuprofen versus placebo on pain after laparotomy in drug dependence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 60 years; (b) candidate for laparotomy; (c) drug dependence.
Exclusion criteria: (a) using analgesic during 8 hours before surgery; (b) during pregnancy of breastfeeding; (c) sensitivity to celecoxib, ibuprofen, or vitamin B; (d) affected with cardiovascular diseases, renal diseases, liver diseases, and gastrointestinal diseases; (e) alcohol abuse.
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:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients systematically one at a time to intervention and control groups.
Blinding: drugs have no label thus patients will not be aware of the type of treatment they receive. In addition, the examiner who will examine the patients is another person that will not be aware of the type of intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-05-14, 1393/02/24
Ethics committee reference number
D/P/16/35/9/87
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Unspecified pain
Primary outcomes
1
Description
measuring the pain severity
Timepoint
1 and 6 hours after surgery
Method of measurement
using VAS scale
Secondary outcomes
1
Description
number of narcotic or analgesic used
Timepoint
during the 6 hours after surgery
Method of measurement
by checking medical record.
Intervention groups
1
Description
200 mg oral celecoxib single dose 1 hour before surgery
Category
Treatment - Drugs
2
Description
400 mg oral ibuprofen single dose 1 hour before surgery
Category
Treatment - Drugs
3
Description
one tablet of vitamin B single dose 1 hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Elham Khorshidi
Street address
Beasat hospital, Shahed Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Elham Khorshidi
Full name of responsible person
Elham Khorshidi
Position
Medical student
Other areas of specialty/work
Street address
Beasat hospital, Shahed Ave.
City
Hamadan
Postal code
Phone
+98 81 8264 0020
Fax
Email
elhamkhorshidi1368@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat hospital
Full name of responsible person
Dr Afshin Farahanchi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beasat hospital, Shahed Ave.
City
Hamadan
Postal code
Phone
+98 81 8264 0020
Fax
Email
afarhanchi1970@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)