Effectiveness of intravenous lidocaine in comparison with venous morphine in reducing acute pain due to organ trauma
Design
This randomized blind study with parallel groups will be performed on 60 patients with acute extremity trauma.Patients will be randomly divided into two groups by throwing coins.The first intervention group will receive 0.1mg / kg morphine sulfate as intravenous injection.The second intervention group will receive 1.5 mg / kg lidocaine as intravenous injection.
Settings and conduct
This randomized blind study will be carried out in patients with acute extremity trauma referring to the Peymaniyeh Hospital of Jahrom. Patients who are eligible for inclusion in the study will be divided into two groups by throwing coins. The first group will receive 0.1 mg / kg morphine sulfate and the second group will receive 1.5 mg / kg lidocaine as a slow intravenous injection. Both groups at the time of referral and then 15 minutes, 30 minutes, 45 minutes and 60 minutes after administration of the drug The use of the numerical scale of pain will be studied. In the present study, the patients in the study, the investigator and the data collector, and the data monitoring committee will be unaware of which individuals are in the group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with acute trauma of the upper or lower extremity ؛ dislocation, fracture as the main cause of recurrence ؛ and the need for pain relief due to severe limb pain.
exclusion criteria: Patients with Disorders levels of consciousness؛ Hemodynamic impairment during drug administration and the susceptibility to Lidocaine and Morphine
Intervention groups
The first intervention group will receive 0.1mg / kg morphine sulfate as intravenous injection.The second intervention group will receive 1.5 mg / kg lidocaine as intravenous injection.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180805040712N2
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Mohammad safaei saruei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 9889
Email address
m.safaie@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-27, 1396/10/06
Expected recruitment end date
2019-01-31, 1397/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of venous lidocaine efficacy with intravenous morphine in reducing acute pain in patients with trauma
Public title
Comparison of venous lidocaine with venous morphine in reducing acute pain due to trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute upper or lower limb trauma including soft tissue injury
Fractures as the main cause of referral
Dislocation
Need to get analgesia due to extreme pain in the limbs
Exclusion criteria:
Disorders of consciousness
Hemodynamic Disorders During Injection
Sensitization Lidocaine and Morphine
Age
From 16 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be divided into two groups by throwing coins. One of the groups will receive intravenous lidocaine and another group will receive intravenous morphine.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study, the patients participating in the study, the researcher, the data collector and the data monitoring committee will be unaware of which individuals are in the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2017-07-05, 1396/04/14
Ethics committee reference number
IR.JUMS.REC.1396.032
Health conditions studied
1
Description of health condition studied
Patients with limb trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
At the time of referral, then 15, 30, 45 and 60 minutes after the administration of the drug
Method of measurement
Using the numerical scale of pain assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group will receive 0.1mg / kg morphine sulfate as a slow intravenous injection.
Category
Treatment - Surgery
2
Description
Intervention group: The second intervention group will receive 1.5 mg / kg lidocaine as a slow intravenous injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymaniye hostpital
Full name of responsible person
اسماعیل رعیت دوست
Street address
Peymaniye Hostpital,Valiye Asr St, Jahrom City, Fars Province
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Email
navidkalani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoos solhjoo
Street address
Jahrom, the end of Motahari Blvd, Pardis Building
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Email
navidkalani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Esmaile raiyat dust
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Jahrom, the end of Motahari Blvd, Pardis Building
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Email
navidkalani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmaile raiyat dust
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Jahrom, the end of Motahari Blvd, Pardis Building
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Email
navidkalani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmaile raiyat dust
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Jahrom, the end of Motahari Blvd, Pardis Building
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Email
navidkalani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD