Objectives: to compare the emergency costs with and without the use of the new protocol reduced renal colic pain. Design: randomized, Single-blind, single-center, phase II clinical trial. Setting and conduct: in Group A, the new protocol for treatment of renal colic is administered. For Group B, The new protocol is not administered. After treatment, the cost for patients in emergency ward will be evaluated. Inclusion criterion: patients with renal colic. Exclusion criterion: patients with cardiovascular disease, high blood pressure and diabetes. Main outcome measure variables: costs in emergency ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112727457N2
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Mehdi Rezaie
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2107
Email address
rezaei.me@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a new protocol for pain relief in renal colic patients on reducing the cost of emergency
Public title
Effects of a new protocol for pain relief in renal colic patients on reducing the cost of emergency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with renal colic. Exclusion criterion: patients with diseases of cardiovascular, high blood pressure and diabetes.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2016-02-19, 1394/11/30
Ethics committee reference number
IR.IUMS.REC.1394.9311307010
Health conditions studied
1
Description of health condition studied
renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
The patients treatment costs in emergency ward
Timepoint
After treatment
Method of measurement
According to hospital records
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: the new protocol reduces colic pain.
Category
Treatment - Drugs
2
Description
Control group: routin treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr Mehdi Rezaie
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rezaie
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 216435210
Fax
Email
rezaei.me@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hosein Saiedi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2107
Fax
Email
rezaei.me@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehdi Rezaie
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 216435210
Fax
Email
rezaei.me@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)