Comparison the efficacy and side effects of ketamine and Dexmedetomidine in reduction of shoulder dislocation in patients referring to the emergency department of Ahwaz Imam Khomeini and Golestan Hospital in 2017
Comparison of efficacy and complications of ketamine and doxedetomidine in patients with shoulder dislocation
Design
double-blind clinical trial parallel, patients randomization to the A and B group
Settings and conduct
All patients presenting to ED with shoulder dislocation randomly divided into two groups:Dexmedetomidine neublize and Ketamine nebulize. The medication is prepared by the fourth person. VAS will be repeated at 0, 10,20, 30, 60 minutes after intervention.
Participants/Inclusion and exclusion criteria
The criteria for entering the study included all patients with the anterior and posterior shoulder dislocation, aged between 65 and 14 years old, and the exclusion criteria included patients with the fracture in the early graft, widespread injury or open arms, patients with decreased consciousness, patients with Deformity and neurologic lesions are the same organs.
Intervention groups
These individuals will be divided into 2 groups A and B, the first group will receive ketamine nebulizer and the second group will receive doxomentomidine nebulizer.
Main outcome variables
Effect of benefit (less pain and fewer side effects) Ketamine or doxedetomidine in sedation during reduction of shoulder dislocation leads to improved therapeutic goals and patients' quality of life, a change in policy and health care management, and improved treatment quality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180530039917N1
Registration date:2018-06-21, 1397/03/31
Registration timing:registered_while_recruiting
Last update:2018-06-21, 1397/03/31
Update count:0
Registration date
2018-06-21, 1397/03/31
Registrant information
Name
Payam Ghoraian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
ghoraian.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-23, 1396/04/02
Expected recruitment end date
2018-06-23, 1397/04/02
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
empty
Scientific title
Comparison the efficacy and side effects of ketamine and Dexmedetomidine in reduction of shoulder dislocation in patients referring to the emergency department of Ahwaz Imam Khomeini and Golestan Hospital in 2017
Public title
Comparison of ketamine and dexmedetomidine in a reduction of shoulder dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inferior and posterior dislocation of shoulder
14 - 65 aged
Exclusion criteria:
Patients with fracture in the primary graph
Excessive injury or open dislocation shoulder
Patients with reduced consciousness
Patients with deformity and neurological lesions in shoulder
Age
From 14 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize in two groups with quadri unit Permutational blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients know they are participating in a study that is aimed to compare the efficacy and side effects of ketamine and Dexmedetomidine in the reduction of shoulder dislocation but they are not informed that they receive placebo or Dexmedetomidine.
The physician who evaluates the clinical status of patients and the nurse who injects the drug are not aware of the medication that patients receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commite of Jundishapur University of Ahvaz
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6435134551
Approval date
2638-09-02, 2017/06/11
Ethics committee reference number
IR.AJUMS.REC.1396.636
Health conditions studied
1
Description of health condition studied
Dislocation of shoulder
ICD-10 code
S43
ICD-10 code description
Dislocation and sprain of joints and ligaments of shoulder girdle
Primary outcomes
1
Description
What is the mean value of VAS score in patients undergoing comorbid reduction of ketamine and doxedetomidine before the intervention at 5, 10, 20, 30 and 60 minutes after receiving the drug?
Timepoint
0,5,10,20 30, 60 minutes after treatmen
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The group will receive 1 Mg/Kg Ketamine nebulized
Category
Treatment - Drugs
2
Description
The group will receive 1 micro gram/Kg Dexmedetomidine nebulized
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Payam ghoraian
Street address
Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
56143661
Phone
+98 61 2267 4822
Email
Pm_ghoraian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mohammad Badvi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 8876 1241
Email
Pm_ghoraian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
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
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Ghoraian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ghoraian.p@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Ghoraian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ghoraian.p@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Ghoraian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ghoraian.p@ajums.ac.ir
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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available