Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001372572
Ethics application status
Approved
Date submitted
24/08/2015
Date registered
16/12/2015
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
comparison of magnesium sulfate and morphine sulfate in renal colic
Scientific title
In patients with renal colic, is magnesium sulfate more effective than morphine sulfate in relieving pain?
Secondary ID [1] 287335 0
nil
Universal Trial Number (UTN)
u1111-1173-4139
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
renal colic 295975 0
Condition category
Condition code
Renal and Urogenital 296256 296256 0 0
Other renal and urogenital disorders
Anaesthesiology 296940 296940 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First 5 ml distilled water intravenous injection, then 50 mg per kg of weight magnesium sulfate in 100 ml normal saline intravenous infusion in 20 minutes, single dose only.
Intervention code [1] 292655 0
Treatment: Drugs
Comparator / control treatment
First 0.1 milligrams per kilogram of weight morphine sulfate intravenous slowly injection, then 100 milliliter normal saline intravenous infusion in 20 minutes. total number of doses administered for each participant is single dose only
Control group
Active

Outcomes
Primary outcome [1] 295914 0
Proportion of participants with at least a 3 point reduction in numeric pain scale.
Timepoint [1] 295914 0
15 minutes after drug administer
Primary outcome [2] 296550 0
the patients were evaluated for any side effects of M.S. and Mg.S. such as vomiting, nausea, low blood pressure, apnea, dizziness and light-headed.
Timepoint [2] 296550 0
15 minutes after drug administer
Secondary outcome [1] 316916 0
Proportion of participants with at least a 3 point reduction in numeric pain scale.
Timepoint [1] 316916 0
30minutes after drug administer
Secondary outcome [2] 318737 0
the patients were evaluated for any side effects of M.S. and Mg.S. such as vomiting, nausea, low blood pressure, apnea, dizziness and light-headed.
Timepoint [2] 318737 0
30 minutes after drug administer

Eligibility
Key inclusion criteria
patients with renal colic with age of 18-55 years
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal failure, pregnancy, systolic blood pressure under 100mmhg, respiratory rate under 12 per minute, opium addict, heart failure, patients that are under treatment with magnesium sulfate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
there are 2 treatment protocol and selection one of them by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
. Simple randomization using sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
we used student t test for statistical analysis and Cochran formula (difference between ratios ) with 80% power and 95% confidence and 25% effect size for sample size calculation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 7113 0
Iran, Islamic Republic Of
State/province [1] 7113 0

Funding & Sponsors
Funding source category [1] 291897 0
University
Name [1] 291897 0
school of medicine shahid sadoughi university of medicine sciense Yazd
Country [1] 291897 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Akram Zolfaghari Sadrabad
Address
Shahid Sadoughi University of Medical Science, Shahidan entezari, Yazd, 8915848587
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 290564 0
Individual
Name [1] 290564 0
Soheila Azimi Abarghouei
Address [1] 290564 0
Shahid Sadoughi University of Medical Science, Shahidan entezari, Yazd, 89158412158
Country [1] 290564 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293406 0
the ethic committee of shahid sadoughi university of medicine science yazd
Ethics committee address [1] 293406 0
school of medicine shahid sadoughi university of medicine science, professor hesabi ,yazd, 8915173143
Ethics committee country [1] 293406 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 293406 0
Approval date [1] 293406 0
20/01/2015
Ethics approval number [1] 293406 0
235385

Summary
Brief summary
Renal colic due to renal stone is a most severe pain had been experienced, and is common cause of patient reference to health centers. Intravenous infusion of morphine sulfate is a common treatment, but its side effect is addiction. It has been mentioned that magnesium sulfate due to its calcium receptors antagonist effect and therefore muscle relaxation, was a pain relief especially in migraine headache.
this study compares effectiveness and side effects of intravenous infusion of morphine sulfate and magnesium sulfate in renal colic patient who were referred to shahid sadoughi educational hospital. This paper is double-blinded randomized control trial study. Eighty patients with renal colic divided in two groups: case group took 50 mg/kg intravenous infusion and the control group took morphine sulfate 0.1 mg/kg intravenous infusion.pain score and probable side effects( such as vomiting, nausea, low blood pressure, apnea and dizziness) during zero, 15 and 30 minutes after infusion in both group recorded by a blinded person, and data analyzed by SPSS software.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59766 0
Dr Akram Zolfaghari Sadrabad
Address 59766 0
Shahid Sadoughi University of Medical Science, Shahidan entezari, Yazd, 8915848587
Country 59766 0
Iran, Islamic Republic Of
Phone 59766 0
+98 3538281954
Fax 59766 0
Email 59766 0
[email protected]
Contact person for public queries
Name 59767 0
Dr Soheila Azimi Abarghouei
Address 59767 0
Shahid Sadoughi University of Medical Science, Shahidan entezari, Yazd, 8915848687
Country 59767 0
Iran, Islamic Republic Of
Phone 59767 0
+98 35 38282682
Fax 59767 0
Email 59767 0
[email protected]
Contact person for scientific queries
Name 59768 0
Dr Akram Zolfaghari Sadrabad
Address 59768 0
Shahid Sadoughi University of Medical Science, Shahidan entezari, Yazd, 8915848587
Country 59768 0
Iran, Islamic Republic Of
Phone 59768 0
+98 3538281954
Fax 59768 0
Email 59768 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntravenous magnesium sulfate vs. morphine sulfate in relieving renal colic: A randomized clinical trial.2021https://dx.doi.org/10.1016/j.ajem.2020.07.035
N.B. These documents automatically identified may not have been verified by the study sponsor.