Comparison of combination of intravenous diazepam and fentanyl with combination of intravenous midazolam and fentanyl in reduction of shoulder joint dislocation in emergency department
1. Determine and compare satisfaction of patients with combination of intravenous diazepam and fentanyl and combination of midazolam and venous fentanyl in onset of shoulder joint
2. Determine and compare the satisfaction of the emergency doctor with the combination of intravenous midazolam and fentanyl and the combination of diazepam and intravenous fentanyl in arthralgic articulation
3. Determine and compare the side effects of drug in diazepam and intravenous fentanyl, and the combination of midazolam and venous fentanyl in the onset of shoulder dislocation
Design
Randomized clinical trial, parallel group with blinded assessment
Settings and conduct
In this study, patients are randomly divided into two groups. In the first group, after receiving the consent of the patient to participate in the study and achieve other entry criteria, a diazepam dose of 0.3 mg / kg will be administered to the patient before reduction and then a standard dose of fentanyl will be used to reduce pain and as soon as the muscles are loosened, the joint will be reduced and the results will be recorded in a special form. In the parallel group, instead of diazepam, midazolam will be given at a dose of 0.03 mg / kg, and the other actions will be similar.
Participants/Inclusion and exclusion criteria
Need for analgesia for joint reduction; no severe underlying illness; age between 18 and 65 years old; aatempt to participate in the study.
Intervention groups
Group one will receive Intravenous diazepam and fentanyl for pre-reduction sedation
Group two will receive Intravenous midazolam and fentanyl for pre-reduction sedation
Main outcome variables
Evaluation of pain before, during and after reduction in the patient with Visual Analogue Scale; evaluation of the incidence of adverse drug reactions during and after joint reduction; assess physician's satisfaction during joint reduction with Likert scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170313033051N1
Registration date:2019-03-30, 1398/01/10
Registration timing:registered_while_recruiting
Last update:2019-03-30, 1398/01/10
Update count:0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Mohammad Afzalimoghaddam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 4848
Email address
afzalimoghadam@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combination of intravenous diazepam and fentanyl with combination of intravenous midazolam and fentanyl in reduction of shoulder joint dislocation in emergency department
Public title
Effect of intravenous diazepam in reduction shoulder joint dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The need for analgesia for joint reduction
No severe underlying diseases
Age 18 to 65 years
The desire to participate in the study
Exclusion criteria:
Lack of desire to participate in the study
Sensitivity to drug used in study
Pregnancy
Hemodynamic instability
Presence of fracture associated with dislocation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not aware of the type of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd,.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1962
Health conditions studied
1
Description of health condition studied
Shoulder dislocation
ICD-10 code
S43.0
ICD-10 code description
Subluxation and dislocation of shoulder joint
Primary outcomes
1
Description
Patient satisfaction according to pain scale
Timepoint
Before reduction, during the reduction and after the reduction
Method of measurement
Using Visual Analogue Scale
2
Description
Uncomplicated joint reduction
Timepoint
During the reduction and after the reduction with intervals 15 minutes for 2 hours
Method of measurement
Examination of vital signs and level of consciousness during and after the procedure
3
Description
Physician Satisfaction
Timepoint
After reduction
Method of measurement
sing Likert scale
Secondary outcomes
1
Description
No need for post-reduction care
Timepoint
During and after the reduction for 2 hours and at intervals of 15 minutes
Method of measurement
Using Glasgow Coma Scale and vital sign monitoring with sphygmomanometer and pulse oximeter
Intervention groups
1
Description
Intervention group: Administration of intravenous Diazepam and intravenous Fentanyl. After obtaining the consent of the patient to participate in the study and to place him randomly in this group, Diazepam at a dose of 0.3 mg / kg slowly will be administered intravenously, and as soon as the patient`s muscles will be relaxed, intravenous Fentanyl at a dose of 3 micg / kg will be injected and after about 30 seconds the reduction maneuver has been carried out by traction counter-traction method, and the duration of the reduction and the number of attempts and possible complications are documented.
Category
Treatment - Drugs
2
Description
Control group: After obtaining the consent of the patient to participate in the study and to place him randomly in this group, Midazolamat a dose of 0.1 mg / kg slowly will be administered intravenously, and then intravenous Fentanyl at a dose of 3 micg / kg will be injected and after about 30 seconds the reduction maneuver has been carried out by traction counter-traction method, and the duration of the reduction and the number of attempts and possible complications are documented.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohammad Afzalimoghaddam
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6690 4848
Email
afzalimoghadam@tums.ac.ir
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Afzalimoghaddam
Street address
Sina Hospital, Imam Khomeini Ave.,
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
afzalimoghadam@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
6th floor, Tehran University of Medical Sciences., Qods Ave., Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?