Efficacy of adding oral Clonidine to standard treatment in acute renal colic
Design
ّFour arm triple blinded, parallel group, randomized clinical trial
Settings and conduct
Scientist prepare and label the drugs and placebo. Patients with acute renal colic who admitted in Alzahra and Kashani hospital (Isfahan city) divided in 4 group after randomization and study manager start treating patient due to randomized numeric table; blinded to treatment protocol. Patients in different groups receive below treatments:
group 1: 10 minutes infusion of 0.1 mg/kg Morphine diluted in 100 ml normal saline and 1 pill of oral Placebo
group 2: 10 minutes infusion of 30mg Ketorolac diluted in 100 ml normal saline and 1 pill of oral Placebo
group 3: 10 minutes infusion of 0.1 mg/kg Morphine diluted in 100 ml normal saline and 1 pill of 0.2 mg oral Clonidine
group 4: 10 minutes infusion of 30mg Ketorolac diluted in 100 ml normal saline and 1 pill of 0.2 mg oral Clonidine
Study observer check and record complications and pain severity with VAS score in beginning of study and after 20 minutes and 40 minutes of treatment; blinded to treatment protocol.
Study manager and scientist inject 0.05 mg/kg IV Morphine if patient pain doesn't reduce after 40 minutes of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-55 years old; normal blood pressure
Exclusion criteria: uncontrolled pain; drug complications
Intervention groups
Patients are divided in 4 group after randomization:
group 1) receive IV Morphine and Placebo
group 2) receive IV ketorolac and Placebo
group 3) receive IV Morphine and oral Clonidine
group 4) receive IV Ketorolac and oral Clonidine
Main outcome variables
Clonidine efficiency in patient pain control and patient need to multiple dose of analgesic agents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130108012072N11
Registration date:2020-10-22, 1399/08/01
Registration timing:retrospective
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Mehrdad Esmailian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3482
Email address
m_esmailian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-05-21, 1399/03/01
Trial completion date
2020-05-21, 1399/03/01
Scientific title
Effect of adding oral clonidine to standard treatments on pain intensity of patients with acute renal colic
Public title
Clonidine efficacy in acute renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement for entering to the study
No Mental Retardation
Non pregnant
No breast feeding
Didn't use of analgesic agents since 4 hours ego
No sensitivity to Morphine or Ketorolac or Clonidine
Blood Pressure >=110/70 mm Hg
No history of chronic liver or kidney injury
VAS (Visual Analog Score)>4
Exclusion criteria:
Analgesic agents use since 4 hours ego
History of drug reaction
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drugs are prepare with scientist and labeled (scientist is blinded to patient's treatment group and efficacy or complications of each groups). Patients are selected with randomized numeric table and don't aware about treatment protocol. Manager use treatment pathway base on patient randomization; blinded about drug that be used and record result and complications.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Alzahra general hospital, Sofeh blv., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8175898595
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.MUI.MED.REC.1397.340
Health conditions studied
1
Description of health condition studied
Acute renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain severity score with Visual Analog Scale
Timepoint
Study beginning, 20 minutes and 40 minutes after treatment
Method of measurement
Visual Analog Scale
2
Description
Drug complications
Timepoint
Study beginning, 20 minutes and 40 minutes after treatment
Method of measurement
Standard questionnaire form
Secondary outcomes
1
Description
Insufficient pain control
Timepoint
40 minutes after treatment
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine
Category
Treatment - Drugs
2
Description
Intervention group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of 0.2 mg oral Clonidine
Category
Treatment - Drugs
3
Description
Control group 1: 0.1 mg/kg Morphine diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo
Category
Treatment - Drugs
4
Description
Control group 2: 30 mg Ketorolac diluted in 100 ml normal saline in 10 minutes infusion and 1 pill of oral Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra general hospital
Full name of responsible person
Mehrdad Esmailian
Street address
Alzahra general hospital, sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
m_esmailian@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mehrdad Esmailian
Street address
Kashani hospital, Kashani street
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
m_esmailian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave., Azadi square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Alzahra hospital, Sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
m_esmailian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Alzahra hospital, Sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
m_esmailian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Alzahra hospital, Sofeh Blv.
City
Isfahan
Province
Isfehan
Postal code
8175898595
Phone
+98 31 3620 2085
Email
m_esmailian@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Whole of data after coding
When the data will become available and for how long
Accessibility after 2021
To whom data/document is available
Everyone
Under which criteria data/document could be used
For seemingly studies data released to academic chairman's
From where data/document is obtainable
Isfahan University of Medical Sciences
What processes are involved for a request to access data/document