A clinical trial to compare the effectiveness of ketamine, propofol/ketamin with propofol/fentanilel for procedure sedation and analgesia of reduction of shoulder dislocation.
A clinical trial to compare the effectiveness of ketamine, propofol/ketamin with propofol/fentanilel for procedure sedation and analgesia of reduction of shoulder dislocation.
Design
150 dislocated shoulder patients who referred to the emergency department of Besat Nahaja Hospital, were chosen randomly and assigned to three intervention groups. A code was allocated to each of the participants.
Settings and conduct
The dislocated shoulder patients who referred to the emergency department of Besat Nahaja Hospital, are chosen as the participants of the study. In this double-blind study, the participants and all of responsible for data collection are unaware of the patients groups and the type of drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 15 and 40 years; lake of underlying disease such as blood pressure, diabetic, cardiovascular disease, and etc; having dislocation orthopedic removable at emergency; Normal examination of the neuromuscular system; non allergenic to sedative drugs.
Exclusion criteria: Cardiovascular instability; having low saccharification; having multiple trauma; possibility of the abdomen or chest bleeding; having head trauma; decreased alertness.
Intervention groups
The first intervention group are revising 1-1.5 mg/kg of intravenous ketamine from 30 to 60 seconds. The second intervention group are revising 1-1.5 mg/kg of intravenous ketamine with 1 mg/kg propofol from 30 to 60 seconds. The third intervention group are revising 1 mg/kg of intravenous propofol with 50 µg fentanyl from 30 to 60 seconds.
Main outcome variables
Evaluation and comparison of rate of pain base on bispectral index scale (BIS) between three intervention groups before and per minute until the completed reduction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040258N1
Registration date:2018-07-11, 1397/04/20
Registration timing:prospective
Last update:2018-07-11, 1397/04/20
Update count:0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Masood Shahabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3321 6512
Email address
m.masaeli@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of ketamine, propofol/ketamin with propofol/fentanilel for procedure sedation and analgesia of reduction of shoulder dislocation.
Public title
Procedural sedation and analgesia of reduction of shoulder dislocation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 15 and 40 years
Lake of underlying disease such as blood pressure, diabetic, cardiovascular disease, and etc
Having dislocation orthopedic removable at emergency
Normal examination of the neuromuscular system
Non allergenic to sedative drug
Exclusion criteria:
Cardiovascular instability
Having low saccharification
Having multiple trauma
Possibility of the abdomen or chest bleeding
Having head trauma
Decreased alertness
Age
From 15 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized, clinical trial based on random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The dislocated shoulder patients who referred to the emergency department of Besat Nahaja Hospital, are chosen as the participants of the study. In this double-blind study, the participants and all of responsible for data collection are unaware of the patients groups and the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Republic of Iran Army University of Medical Sciences
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.AJAUMS.REC.1397.002
Health conditions studied
1
Description of health condition studied
Dislocation of shoulder joint
ICD-10 code
S43.0
ICD-10 code description
Subluxation and dislocation of shoulder joint
Primary outcomes
1
Description
Rate of pain
Timepoint
before and per minute until the completed reduction
Method of measurement
bispectral index scale (BIS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group I: patients are revising 1-1.5 mg/kg of intravenous ketamine from 30 to 60 seconds.
Category
Treatment - Drugs
2
Description
Intervention group II: patients are revising 1-1.5 mg/kg of intravenous ketamine with 1 mg/kg propofol from 30 to 60 seconds.
Category
Treatment - Drugs
3
Description
Intervention group III: patients are revising 1 mg/kg of intravenous propofol with 50 µg fentanyl from 30 to 60 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Nahaja Hospital
Full name of responsible person
Masood Shahabian
Street address
Besat Nahaja Hospital, Basij Highway
City
Tehran
Province
Tehran
Postal code
1735838544
Phone
+98 21 3321 6512
Email
info@website.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Solemani
Street address
Vice Chancellor for Research, Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Masood Shahabian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
elmpajooh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Masood Shahabian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
elmpajooh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Masood Shahabian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
elmpajooh@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be 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
The total data to be included are the primary and secondary effects to be shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Masood Shahabian provides the analysis code to the applicants via email: elmpajooh@yahoo.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.