Comparison of reducing success and complication of shoulder dislocation with “Succinylcholine and Thiopental”, “Propofol and Fentanyl” and “Fentanyl and Midazolam” in Emergency Department
The aim of this Concurrent/parallel triple blind randomized controlled clinical trial is the Comparison of reducing success and complication of shoulder dislocation with three different palliative and relaxant regimen consist of “Succinylcholine and Thiopental”, “Propofol and Fentanyl” and “Fentanyl and Midazolam” to determine the best mixed regimen with higher success rate and lower complication for our patients in this region. According to block randomization, 150 cases aged between 16 and 65 years with anterior or posterior shoulder dislocation will be allocated into three groups with 50 cases in each.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009264811N1
Registration date:2012-04-28, 1391/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-28, 1391/02/09
Registrant information
Name
Ali Kabir
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 1993
Email address
a.kabir@nhri.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahid Beheshti University
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of reducing success and complication of shoulder dislocation with “Succinylcholine and Thiopental”, “Propofol and Fentanyl” and “Fentanyl and Midazolam” in Emergency Department
Public title
Clinical trial of different treatments in shoulder dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Cases aged between 16 and 65 with anterior/posterior shoulder dislocation including those with avulsion fracture of the greater tuberosity or of the glenoid labrum who have referred to emergency department and signed a written informed consent. Exclusion criteria: Patients with physical status higher than II according to American Society of Anesthesiologists (ASA); cases with major fracture-dislocation; cases with other major trauma; history of drug abuse; intoxicated patients.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Daneshjoo Bolvd., Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-01-17, 1390/10/27
Ethics committee reference number
90-1-134 / 8175
Health conditions studied
1
Description of health condition studied
Dislocation of shoulder joint
ICD-10 code
S43.0
ICD-10 code description
Dislocation of shoulder joint
2
Description of health condition studied
Dislocation of shoulder joint
ICD-10 code
S40.0
ICD-10 code description
Contusion of shoulder and upper arm
Primary outcomes
1
Description
success of reduction
Timepoint
after each reducing process
Method of measurement
physical examination and X-ray
Secondary outcomes
1
Description
complication
Timepoint
after reduction and each subsequesnt visit
Method of measurement
history, physical examination and X-ray
Intervention groups
1
Description
Protocol A consist of 20 mg Succinylcholine and 100 mg Thiopental
Category
Treatment - Drugs
2
Description
Protocol B consist of 1-3 mg/Kg Propofol and 2-3 mg/Kg Fentanyl
Category
Treatment - Drugs
3
Description
Protocol C consist of 2-3 mg/Kg Fentanyl and 3-5 mg Midazolam
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr Afshin Amini
Street address
Imam Hossein Hospital, Nezam Abad St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Amini
Street address
Imam Hossein Hospital, Nezam Abad St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Amini
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hossein hospital, Nezam Abad st.
City
Tehran
Postal code
6314116177
Phone
+98 21 7755 8081
Fax
Email
A.amini@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Ali Kabir
Position
MD, MPH
Other areas of specialty/work
Street address
No. 255, Central Building, Adjacent Milad Tower, Iran University of Medical Sciences