Comparison of the Effect of Intravenous Magnesium Sulfate-Morphine with Morphine on Pain Reduction in Extreme Limbs in Emergency Department
Design
This is a double-blind randomized clinical trial and patients and researchers are not aware of the type of intervention. In this study, 64 patients will participate. Randomly, each patient will be injected with morphine and magnesium sulfate or morphine. Time intervals of 0 - 15 - 30 - 45 and 60 minutes after drug injection are used to determine the severity of pain.
During the study, the patient's condition is monitored by pulse oximeter, respiratory and pulse monitoring, blood pressure and knee motor reflex every 10 minutes.
Settings and conduct
This is a double-blind randomized clinical trial and patients and researchers are not aware of the type of intervention. In this study, 64 patients with isolated limb fractures referred to Golestan and Imam Khomeini hospitals in Ahvaz will participate.
At admission, the patient's pain level is determined on an 11-point scale (0-10). Randomly, each patient will be injected with 0.1 mg / kg morphine and 30 mg / kg magnesium sulfate or 0.1 mg / kg morphine. Time intervals of 0 - 15 - 30 - 45 and 60 minutes after drug injection are used to determine the severity of pain.
During the study, the patient's condition is monitored by pulse oximeter, respiratory and pulse monitoring, blood pressure and knee motor reflex every 10 minutes.
Participants/Inclusion and exclusion criteria
Organ fractures
Intervention groups
In the intervention group, each patient will be given 1.1 mg / kg morphine and 30 mg / kg magnesium sulfate.
The control group will be injected with 1.1 mg / kg morphine.
Main outcome variables
Pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190617043913N1
Registration date:2020-01-30, 1398/11/10
Registration timing:registered_while_recruiting
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Majid Fattah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3966
Email address
majid.fattah1357@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of magnesium sulfate plus morphine versus morphine alone in long bone fractures pain alleviation in the emergency department
Public title
Comparison of magnesium sulfate plus morphine versus morphine alone in long bone fractures pain alleviation in the emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Long bone fracture
Exclusion criteria:
Cardiovascular disease
Pregnancy
Drug addiction
Reduced alertness
alcohol consumption
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. Patients and researchers are not aware of the type of group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-04-06, 1398/01/17
Ethics committee reference number
IR.AJUMS.REC.1398.143
Health conditions studied
1
Description of health condition studied
Long fractures
ICD-10 code
S22.4
ICD-10 code description
Multiple fractures of ribs
Primary outcomes
1
Description
Pain
Timepoint
Patient pain scores at 0 - 15 - 30 - 45 and 60 minutes after drug administration
Method of measurement
11 numeric grading scale (0-10)
Secondary outcomes
1
Description
Breath rate
Timepoint
Every 10 minutes
Method of measurement
Pulse Oximeter
2
Description
Pulse rate
Timepoint
Every 10 minutes
Method of measurement
Pulse Oximeter
3
Description
Blood pressure
Timepoint
Every 10 minutes
Method of measurement
Barometer
4
Description
Knee-jerk reflex
Timepoint
Every 10 minutes
Method of measurement
Reflex hammer
Intervention groups
1
Description
Intervention group: Each patient will be given 1.1 mg / kg morphine and 30 mg / kg magnesium sulfate.
Category
Treatment - Drugs
2
Description
Control group: Will be injected with 1.1 mg / kg morphine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Meisam Moezzi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
33118- 61357
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
golestanhospital@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Sasan Moogahi
Street address
Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3221 6104
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in Research Affairs, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Blv
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
U-98032
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor in Research Affairs, Ahvaz Jundishapur University of Medical Sciences