In this double-blind clinical trial, 100 patients with a clinical diagnosis of acute renal colic and acute pain radiating to the groin or lower abdomen suddenly after obtaining informed consent based on inclusion criteria aged 18 to 55 years and more intense pain than 5 exclusion criteria a history of seizures, heart disease, liver, kidney or metabolic, systolic blood pressure less than 90 were enrolled. After obtaining demographic information and vital signs, ECG and arterial oxygen saturation are randomly assigned to one of two groups. The first group treated with the standard protocol of 0.1 mg per kg of morphine and 30 mg ketrolac with 100 ml of normal saline as placebo as a 15 minute intravenous infused.
The second group, in addition to the standard protocol, 15 mg per kg of magnesium sulfate intravenously with 50% of the total volume 100 ml (dissolved in saline) will be administered within 15 minutes. The pain VAS score and vital signs and arterial oxygen saturation on admission and after 30 and 60 minutes after injection is measured. In the case of VAS higher than 5 in each group 30 minutes after the first dose of 3 mg of morphine in morphine consumption in patients will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020223552N6
Registration date:2016-04-23, 1395/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-23, 1395/02/04
Registrant information
Name
Abolfazl Jokar
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 2134
Email address
dr.a.jokar@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Arak University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of magnesium sulfate in treatment of acute renal colic
Public title
Efficacy of magnesium sulfate in treatment of acute renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of renal colic; aged between 18 and 55 years; VAS> 5.
Exclusion criteria:
A history of seizures, heart , liver, kidney or metabolic disease ; T > 38 ; systolic blood pressure< 90 mm Hg ; pregnancy; abdominal pain; opioid addiction ; use of calcium channel blocker .
Age
From 18 years old to 55 years old
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization Will be done with using a random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
St. Alamolhoda,St. Maskan, Arak
City
Arak
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.ARAKMU.REC.1394.44
Health conditions studied
1
Description of health condition studied
acute renal colic
ICD-10 code
9
ICD-10 code description
N20,N21,N22,N23
Primary outcomes
1
Description
Pain
Timepoint
Arrival, 30 minutes and 60 minutes after injection
Method of measurement
VAS ruler
Secondary outcomes
1
Description
Arterial oxygen saturation
Timepoint
At Arrival and 30 minutes and 60 minutes after injection
Method of measurement
Digital pulse oxymetery
2
Description
Systolic Blood Pressure
Timepoint
At Arrival and 30 minutes and 60 minutes after injection
Method of measurement
sphingmomonometer
3
Description
Diastolic Blood Pressure
Timepoint
At Arrival and 30 minutes and 60 minutes after injection
Method of measurement
sphigmomonometer
4
Description
Heart Rate
Timepoint
At Arrival and 30 minutes and 60 minutes after injection
Method of measurement
Pulse per minute
5
Description
Respiratory Rate
Timepoint
At Arrival and 30 minutes and 60 minutes after injection
Method of measurement
Respiration Per Minute
Intervention groups
1
Description
Intervention group: 15 mg/kg of magnesium sulfate 50 %( institute Pasteur.Tehran .Iran )with total volume 100 ml (dissolved in Normal saline) will be administered intravenously within 15 minutes.
in addition Treatment with the standard protocol of 0.1 mg/kg of morphine sulfate and 30 mg ketorolac intravenously the same time
Category
Treatment - Drugs
2
Description
Control group : 100 ml of normal saline as placebo will be administered intravenously within 15 minute.
in addition Treatment with the standard protocol of 0.1 mg/kg of morphine sulfate and 30 mg ketorolac intravenously the same time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
arak valiasr hospital
Full name of responsible person
ad abolfazl jokar
Street address
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
School of Medicine, Arak
City
Arak
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 of Arak 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
Arak University of Medical sceinces
Full name of responsible person
Dr. Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali Asr Hospital, Arak
City
Arak
Postal code
Phone
00
Fax
Email
dr.a.jokar@gmail.com mabj_86@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
Phone
+86 32222003
Fax
Email
rahenorayaneh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Valiasr Hospital, Arak
City
Arak
Postal code
Phone
00
Fax
Email
dr.a.jokar@gmail.com
mabj_86@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)