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Evaluation Of The Effect Of Intravenous Magnesium Sulfate On Pain Relief In Patients With Acute Renal Colic- A Randomized Double Blind Clinical Trial

Protocol summary

Study aim
• Comparison Of The Effect Of Intravenous Magnesium Sulfate With Morphine On Pain Reduction In Patients With Acute Renal Colic In 20 Minutes • Comparison Of Effect Of Intravenous Magnesium Sulfate With Morphine On Pain Reduction In Patients With Acute Renal Colic In 30 Minutes • Comparison Of Effect Of Intravenous Magnesium Sulfate With Morphine On Pain Reduction In Patients With Acute Renal Colic In 60 Minutes • Comparison Of The Effect Of Intravenous Magnesium Sulfate With Morphine On Pain Reduction In Patients With Acute Renal Colic In 120 Minutes • Comparison Of Effect Of Intravenous Magnesium Sulfate With Morphine On Pain Reduction In Patients With Acute Renal Colic In 180 Minutes • Determining And Comparing The Effect Of Intravenous Magnesium Sulfate On Pain Reduction In Patients With Acute Renal Colic In Minutes 20, 30, 60, 120, And 180 • Determine And Compare The Effect Of Morphine On Pain Reduction In Patients With Acute Renal Colic In Minutes 20, 30, 60, 120 And 180 • Comparison Of The Effect Of Intravenous Magnesium Sulfate With Morphine On Adverse Reactions In Patients With Acute Renal Colic • Comparison Of The Effect Of Intravenous Magnesium Sulfate With Morphine On Patients' Satisfaction With Acute Renal Colic
Design
Initially, Patients With Acute Renal Colic Who Were Eligible For Study And Received Morphine Treatment After 20 Minutes, Also Had A Score Of More Than 6, Were Taken To Participate In A Written And Informed Consent Study, And Then, According To A Random Number Table And Were Randomly Divided Into Two Equal Groups.
Settings and conduct
A Randomized, Double Blind Clinical Trial Study On Patients With Acute Renal Colic In An Adult Age Group Of 18-60 Years Old Referred To Shahid Beheshti University Of Medical Sciences Hospital In Shohadaye Tajrish Affiliated To Shahid Beheshti University Of Medical Sciences During 2018.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The adult patients with acute renal colic, Age ranges of 18-60 years old, The severity of pain between 6 to 10 based on the vas criteria GCS= 15. Exclusion Criteria: Pregnancy Or Suspicion Of Pregnancy, History Of Alcohol Addiction Sensitization To Morphine Or Pain Medication, History Of Mental Illness And Depression And Recent Sedation Or Antipsychotics And Calcium Intake Of Blocker Channel, History Of Drug Dependence, Receiving Analgesic In 6 Recent Illness, Neuromascular Disease And Underlying Bradycardia (Heart Rate Less Than 60), Long Qrs Interval, History Of Heart And Kidney Disease, Liver And Liver Disease, Seizure And History Of Drop In Pressure, Abdominal Pain And Probability Of Peritonitis, Lack Of Consent Of The Patient From Continuing The Study, Unstable Patient With Clinical Condition And Pressure Drop (Systolic Pressure Less Than 90 Or Pressure Foot 20% Of The Base) And A Drop In Heart Rate To Less Than 8, And A Drop In Respiratory Rate To Less Than 60 During The Study.
Intervention groups
Magnesium Sulfate Group: Patients With Acute Renal Colic In This Group Received Magnesium Sulfate At A Dose Of 2 G Of 50% Solution At 100 Cc At 15 Minutes. Morphine Group: In Patients With Acute Renal Colic, Morphine Was Administered At A Dose Of 0.1 Mg / Kg To 100 Cc At 15 Minutes.
Main outcome variables
The Primary Outcome Was Pain Reduction And Pain Score Of Less Than 3 Which Was Recorded At 0, 20, 30, 60, 120, 180 And 180 Minutes After Injection In Patients With Acute Renal Colic, Both Groups Of Morphine And Magnesium Sulfate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171206037774N1
Registration date: 2018-02-04, 1396/11/15
Registration timing: registered_while_recruiting

Last update: 2018-02-04, 1396/11/15
Update count: 0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Fatemeh Derakhshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1429
Email address
dr.fatemeh.derakhshani62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of The Effect Of Intravenous Magnesium Sulfate On Pain Relief In Patients With Acute Renal Colic- A Randomized Double Blind Clinical Trial
Public title
The Effect Of Venous Magnesium Sulfate On Pain Relief In Patients With Acute Renal Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Adult Patients With Acute Renal Colic Are Between The Ages Of 18-60 And The Severity Of Pain Between 6 To 10 Based On The VAS Criteria And GCS= 15.
Exclusion criteria:
Pregnancy Or Suspicion Of Pregnancy, History Of Alcohol Addiction Sensitization To Morphine Or Pain Medication, History Of Mental Illness And Depression And Recent Sedation Or Antipsychotics And Calcium Intake Of Blocker Channel, History Of Drug Dependence, Receiving Analgesic In 6 Recent Illness, Neuromascular Disease And Underlying Bradycardia (Heart Rate Less Than 60), Long Qrs Interval, History Of Heart And Kidney Disease, Liver And Liver Disease, Seizure And History Of Drop In Pressure, Abdominal Pain And Probability Of Peritonitis, Lack Of Consent Of The Patient From Continuing The Study, Unstable Patient With Clinical Condition And Pressure Drop (Systolic Pressure Less Than 90 Or Pressure Foot 20% Of The Base) And A Drop In Heart Rate To Less Than 8, And A Drop In Respiratory Rate To Less Than 60 During The Study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Table Of Random Numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Due To The Double-Blindness Of The Study, Throughout The Study, The Patients, Physicians, Nurse-Injectors Were Unaware Of All Stages Of The Study, And The Preparation And Injection Of Medications By Two Nurses Or Residents Was Carried Out So That The Person Preparing The Medication From The Recipient The Medication And The Nurse Injecting Drug Was Unaware. All Drug Injection Syringes Were United And Randomized And Recorded By One Person (Emergency Medicine Assistant).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway (Evin), adjacent to Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Building No. 2, 6th floor, Secretariat of the Ethics Committee, Research Directorate
City
Tehran
Province
Tehran
Postal code
1617181514
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
2548

Health conditions studied

1

Description of health condition studied
Acute Renal Colic
ICD-10 code
N23
ICD-10 code description
Renal Colic

Primary outcomes

1

Description
Reducing Pain
Timepoint
20, 30, 60, 120, 180 min
Method of measurement
VAS

Secondary outcomes

1

Description
Side Effect
Timepoint
180 min
Method of measurement
Observation

Intervention groups

1

Description
Intervention Group: Patients With Acute Renal Colic In This Group Received Magnesium Sulfate At A Dose Of 2 G Of 50% Solution At 100 Cc At 15 Minutesmagnesium sulfate at a dose of 2 g of 50% solution at 100 cc at 15 minutes.
Category
Treatment - Drugs

2

Description
Control group: In Patients With Acute Renal Colic, Morphine Was Administered At A Dose Of 0.1 Mg / Kg To 100 Cc At 15 Minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Alireza Majidi
Street address
Tajrish Square
City
Tehran
Province
Tehran
Postal code
1819151412
Phone
+98 21 25719
Email
alirezamajidi330@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Majidi
Street address
Tajrish Square
City
Tehran
Province
Tehran
Postal code
1819141512
Phone
+98 21 25719
Email
alirezamajidi330@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Arehemi Dolatabadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tajrish Square
City
Teharn
Province
Tehran
Postal code
1918141512
Phone
+98 21 25719
Email
dr.fatemeh.derakhshani62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Majidi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tajrish Square
City
Tehran
Province
Tehran
Postal code
1819141512
Phone
+98 21 25719
Email
alirezamajidi330@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Majidi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tajrish Square
City
Tehran
Province
Tehran
Postal code
1819141512
Phone
+98 21 25719
Email
alirezamajidi330@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All Collected Data Will Analyzed Then Will Accessible To All In The Form Of A Dissertation As Well As A Published Article.
When the data will become available and for how long
After Publishing the Paper.
To whom data/document is available
All Collected Data Will Analyzed Then Will Accessible To All In The Form Of A Dissertation As Well As A Published Article.
Under which criteria data/document could be used
All Collected Data Will Analyzed Then Will Accessible To All In The Form Of A Dissertation As Well As A Published Article.
From where data/document is obtainable
The Journal Website
What processes are involved for a request to access data/document
Search in Databases
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