Comparative study of controlling the pain in patients that present to ED with renal colic with intravenous ketofol and intravenous morphin sulfate after reciving standard treatment
Replacment of treatment of renal colic patients with ketofol instead of morphine sulfate
Design
A clinical trial with a control group and a parallel group that was randomized in two-way blind and phase 3 was performed on 86 patients and randomized Excel function will be used for randomization.
Settings and conduct
Patients with renal colic who refer to the emergency department of Ayatollah Mousavi Hospital in Zanjan between 1400/04/15 and 1400/06/15 and have the conditions and desire to enter our plan using the randomization method and the method There will be two blind strains in which the patient and resident are kept blind to the type of injectable drug.
Participants/Inclusion and exclusion criteria
Patients with definitive diagnosis of renal colic with a desire to participate in the study and a minimum of 16 years and a maximum of 60 years of both sexes without having an underlying disease and addiction and history of allergies.
Intervention groups
Patients with renal colic who are included in the study are divided into two groups and in the intervention group ketofol at a dose of 0.75 mg / kg body weight is injected intravenously and in the control group morphine sulfate at a dose of 0.1 Mg / kg body weight is injected intravenously.
Main outcome variables
Level of controlling the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210327050778N1
Registration date:2021-07-23, 1400/05/01
Registration timing:registered_while_recruiting
Last update:2021-07-23, 1400/05/01
Update count:0
Registration date
2021-07-23, 1400/05/01
Registrant information
Name
Hossein Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3355 0591
Email address
drhosseinrahmani01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of controlling the pain in patients that present to ED with renal colic with intravenous ketofol and intravenous morphin sulfate after reciving standard treatment
Public title
Comparison of ketofol and intravenous morphin sulfate in controlling the pain in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients presenting with back and side pain and hematuria who have a definitive diagnosis of renal colic using physical examination,laboratory tests and radiologic measures such as ultrasonography and abdomino-pelvic CT
Age between 16 to 60 years
Willingness to participate in the study
No history of underlying disease, allergies or addiction
Exclusion criteria:
Renal colic patients with any sort of known drug addiction
Renal colic patients aged under16 or over 60
Renal colic patients with underliying illness
Renal colic patients with any history of allergia
Pregnant patients
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed based on the Randomised software of Excel program in the patients included in the plan and individually
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, which is two-way blind, the people involved in the project include renal colic patient and resident performing clinical trial and supervisor and statistical consultant and drug injecting nurse. Due to the two-way blindness of patient and resident study. They are unaware of the type of drug received by the patient and are kept blind. Thus, we have two classes of drugs, including morphine sulfate and vectofol Is ignorant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
No.1,Mahdavi Blvd.,Karmandan Town
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2020-09-17, 1399/06/27
Ethics committee reference number
IR.ZUMS.REC.1399.230
Health conditions studied
1
Description of health condition studied
Renal Colic
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with kalculus of ureter
Primary outcomes
1
Description
Level of controlling the pain
Timepoint
10, 30,60, and120 minute after intervention
Method of measurement
Visual analogue scale system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The second group, which is also called the intervention group in this trial, is injected intravenously with ketofol at a dose of 75 mg per kg body weight. Then the amount of pain control is recorded based on the VAS system and finally the data are analyzed. will be.
Category
Treatment - Drugs
2
Description
Control group: The first group is given intravenous morphine sulfate at a dose of 0.1 mg per kg body weight intravenously. Then the amount of pain control will be recorded based on the VAS system and data analysis will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Hossein Rahmani
Street address
Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 8687
Fax
+98 24 3301 8687
Email
Zums.ac.ir@Csa
Web page address
Http://www.zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahin Ganjkhani
Street address
No.1., Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 8687
Fax
+98 24 3301 8687
Email
Zums.ac.ir@csa
Web page address
Http://www.zums.ac.ir
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Hossein Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 8687
Email
Ramdrrah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hossein Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 6687
Email
Ramdrrah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hossein Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Mahdavi Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 8687
Email
Ramdrrah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available