The aim of this study is to compare intravenous pethidine and ketorolac in reduction the biliary colic pain. It is designed as a clinical trial. Patients aged between 30 and 60 year with biliary colic will be enrolled the study. Exclusion criteria are drug abuse and allergy for drugs.80 patients will be divided into two groups (pethidine and ketorolac) based on random block method. Pain will be compare between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061134367N1
Registration date:2017-06-11, 1396/03/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
omid bameri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 1954
Email address
bamerio931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2017-07-14, 1396/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous pethidine and ketorolac in reduction the biliary colic pain
Public title
Pethidine and ketorolac in biliary colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Patients aged between 30 and 60 year with biliary colic will be enrolled the study. Exclusion criteria are drug abuse and allergy for drugs.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences ethical committee
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad
City
Mashhad
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MUMS.fm.REC1395.117
Health conditions studied
1
Description of health condition studied
Biliary colic
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
Each 30 minutes for 1 hour
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intravenous pethidine (1 mg/kg) with maximum dose 60 mg.
Category
Treatment - Drugs
2
Description
Intravenous ketorolac (30 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. Omid Bameri
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad
City
Mashhad
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, Mashhad 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
Emam Reza hospital
Full name of responsible person
Dr. Omid Bameri
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3316 4058
Fax
Email
Bamerio931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Omid Bameri
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3316 4058
Fax
Email
Bamerio931@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Omid Bameri
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3316 4058
Fax
Email
Bamerio931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)