Comparison of the effect of intravenous morphine and fentanyl skin patch on pain intensity of patients with shank bone fracture
Design
Clinical trials with community based and pragmatic control group, with parallel groups, one blind, randomized
Settings and conduct
Clinical and one-blind clinical anesthesia study on patients referred to the emergency department of Valiasr Hospital in Arak city with leg fracture.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years old; fracture of the leg
Exclusion criteria: Failure to detect fractures in radiography photos; Background of underlying diseases
Intervention groups
Case group (n=60) : Fentanyl patch in the same areas (left deltoid muscle, right deltoid muscle, left and right chest at the top of the nipple after shivering)
Control group (n=60) : Received 0.1 mg / kg vial of morphine
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023552N15
Registration date:2018-05-04, 1397/02/14
Registration timing:retrospective
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
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 for Research , Arak University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intravenous Morphine with Fentanyl Transdermal Patches on pain intensity of Patients with Fracture of Tibia
Public title
Effect of intravenous morphine with fentanyl skin patch on shin bone fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fracture of Tibia
Aged 18 years and older
Exclusion criteria:
Failure to detect fractures in radiographic images
Background of underlying diseases
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Not accidental
Blinding (investigator's opinion)
Single blinded
Blinding description
Analyzer Blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak, Rahahan Street
City
Arak
Province
Markazi
Postal code
3819838453
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
Ir.arakmu.rec.1395.139
Health conditions studied
1
Description of health condition studied
Fracture of Tibia
ICD-10 code
S82.2
ICD-10 code description
Fracture of tibia
Primary outcomes
1
Description
severity of pain
Timepoint
Every 20 minutes 2 hours after the first administration of morphine, or fentanyl skin patch
Method of measurement
VAS ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fentanyl patch is affixed in the same area and is fastened by a person
Category
Treatment - Other
2
Description
Control group: received morphine 0.1mcg / kg intravenously
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Vali Asr Hospital
Full name of responsible person
Dr. Abolfazl Jokar
Street address
Arak, Valiasr Square, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
381787974
Phone
+98 86 3465 5314
Email
rahenorayaneh@yhaoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak, Sardasht, School of Medicine
City
Arak
Province
Markazi
Postal code
381787974
Phone
+98 86 3465 5314
Email
rahenorayaneh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Jokar
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Arak, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
381787974
Phone
+98 86 3465 5314
Fax
Email
dr.a.jokar@gmail.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
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Arak, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
381787974
Phone
+98 86 3465 5314
Fax
Email
dr.a.jokar@gmail.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
Latest degree
Specialist
Other areas of specialty/work
Street address
Arak, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
381787974
Phone
+98 86 3465 5314
Fax
Email
dr.a.jokar@gmail.com
Web page address
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main consequence of sharing is possible
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
For scholars working in academia and academia
Under which criteria data/document could be used
researchers
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
Once the author agrees, the online data will be available online