This study is designed to evaluation an alternative relief regime for patients with renal colic.
Design
Controlled clinical trial with parallel group, single-blind randomized, Phase 3 on 80 patients. The rand function of the Excel software is used for randomization.
Settings and conduct
Randomized single-blind randomized clinical trial (patients blinded to the patient's lack of knowledge of the drug), patients admitted to the emergency department of Kowsar and Tohid hospitals with acute renal colic attack, with informed consent of the patients, randomly (using the method of random blocks) are divided into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Renal colic
Exclusion criteria:
Drug hypersensitivity
People with stroke or high blood pressure
Eye injuries
Increased cerebrospinal fluid pressure
Increased intraocular pressure
Psychiatric disorders such as schizophrenia
Toxic thyroid
Unwillingness to enter the study
Intervention groups
The first intervention group received 0.1 mg / kg morphine intravenously and 5 cc normal saline as placebo BY nasal spry, the second intervention group 0.15 mg / kg oral ketamine by nasal spry plus 5 cc normal saline as placebo
Main outcome variables
Pain grade caused by kidney stones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141208020249N7
Registration date:2020-09-27, 1399/07/06
Registration timing:retrospective
Last update:2020-09-27, 1399/07/06
Update count:0
Registration date
2020-09-27, 1399/07/06
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ketamine effect against morphine effect on Renal colic Pain management
Public title
The effect of ketamine on renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Flank colic with kidney stone diagnosis
Exclusion criteria:
Drug hypersensitivity
People with stroke or high blood pressure
Eye injuries
Increased cerebrospinal fluid pressure
Increased interocular pressure
Psychiatric disorders such as schizophrenia
Toxic thyroid
Unwillingness to enter the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Excel software rand function is used for randomization. To do this, we create a column of numbers from one to 80 using the command =RAND () * (0-0-80) random numbers. The columns of even numbers are in the case group and the odd numbers are in the control group, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The injected drug is given to patients prepared in the syringe and inhaled drug is given to patients prepared in the sprayer with code, and only the researcher will be aware of its contents.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Management of Medical Researches and Information, Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Kurdistan, Iran POB 6617713446
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.MUK.REC.1398.276
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
Renal colic score
Timepoint
Minutes 0, 10, 15, 30, 60
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 0.1 mg / kg intravenous morphine and 5 cc normal saline nasal spry as placebo
Category
Treatment - Drugs
2
Description
Intervention group: 0.15 mg / kg nasal spry ketamine plus 5 cc normal saline as placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Kourosh Akhbari
Street address
Tohid Hospital, Gheriashan St
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3366 4645
Email
akhbarikourosh@gmail.com
2
Recruitment center
Name of recruitment center
Sanandaj's Kowsar Hospital
Full name of responsible person
Kourosh Akhbari
Street address
Kowsar Educational and Medical Center, Mahvi Boulevard,Lower Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3361 1231
Email
akhbarikourosh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Management of medical research and information, Kurdistan University of Medical Sciences, Kurdistan University of Medical Science, Sanandaj, POB 6617713446
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Alireza Honarmand
Position
Emergency Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice Chancellor in Research Affair, Kurdistan University of Medical Sciences, Pasdaran Ave., Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Fax
+98 87 3366 4645
Email
honarmandalireza542@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Kourosh Akhbari
Position
science Committee member of Emergency Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Management of Medical Researches and Information, Kurdistan University of Medical Sciences, pasdaran Blvd, Sanandaj, Kurdistan, Iran . POB 6617713446
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
akhbarikourosh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies