comparison of effectiveness of thiopental versus midazolam in patients with shoulder dislocation who come to emergency department of Shariati and Imam Khomeini Hospitals
Aims: To comparison effectiveness of midazolam versus thiopantal in patients with shoulder dislocation who come to emergency departments of Shariati and Imam Khomeini Hospitals. Inclusion criteria: All patients who is suffering from shoulder dislocation will enrolled to the study.Major exclusion criteria: unwilling to study participation, drugs sensitivity, fracture dislocation. Study community: All patients come to emergency departments of Shariati and Imam Khomeini Hospitals with shoulder dislocation.Sample size: 60 patients. Intervention: It is a randomized double blind and parallel clinical trial and patients randomly assign as interventions or controls. In interventions patients receive thiopantal (1-2 mg/kg ) I.V. with fentanyl (1-2 microgr/kg) I.V. for sedation and controls receive midazolam (0.05-0.1 mg/kg) I.V. with fentanyl (1-2 microgr/kg) I.V. for sedation. Duration of intervention: 2014.08.22 till 2014.12.22. Outcomes: time of starting loss of conciseness and and time of arousal from sedation. Muscle relaxation, patients and physician satisfaction, pain before and after reduction and number of physician effort for reduction and also complications will evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408068872N5
Registration date:2014-08-23, 1393/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-23, 1393/06/01
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effectiveness of thiopental versus midazolam in patients with shoulder dislocation who come to emergency department of Shariati and Imam Khomeini Hospitals
Public title
comparison of effectiveness of thiopental versus midazolam in patients with shoulder dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: All patients come come to Shariati and Imam Khomeini Hospitals with shoulder dislocatin during study period will enrolled to the study. Exclustion criterias: Severe nourovascular damages; coming after 24 hours; fracture dislocation; multiple trauma patient; unwilling to study participation; decreased level of conciousness; unstable vital signs; drugs sensitivity; ilicit drug abusers; age < 18; pregnant women; hepato renal disorders.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Gods Street, Keshavarz Ave.
City
Tehran
Postal code
Approval date
2014-07-08, 1393/04/17
Ethics committee reference number
93/d/130/858
Health conditions studied
1
Description of health condition studied
shoulder dislocation
ICD-10 code
S43.0
ICD-10 code description
Dislocation of shoulder joint
Primary outcomes
1
Description
number of effort for reduction
Timepoint
after termination of reduction
Method of measurement
question from physician
2
Description
muscle relaxation
Timepoint
after termination of reduction
Method of measurement
qualitave questionnaire
3
Description
pain evaluation
Timepoint
before and just after reduction
Method of measurement
Neumeric Rating Scale
4
Description
loss of conciousness time
Timepoint
one time after loss of responsiveness
Method of measurement
second, cornometer
5
Description
time of arousal
Timepoint
time of full responsiveness
Method of measurement
second, cornometer
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
After termination of Procedure
Method of measurement
Qualitative questionnare
2
Description
physician satisfaction
Timepoint
After termination of Procedure
Method of measurement
Qualitative questionnare
3
Description
complications
Timepoint
After termination of procidure
Method of measurement
questionnare(apnea, long decreased level of contiousness, nausea and vomiting, chest wall rigidity)
Intervention groups
1
Description
In control group, patients receive midazolam (0.05-0.1 mg/kg) I.V. with fentanyl (1-2 microgr/kg) I.V. for sedation.
Category
Treatment - Drugs
2
Description
In intervention group, patients receive thiopantal (1-2 mg/kg ) I.V. with fentanyl (1-2 microgr/kg) I.V. for sedation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Morteza Saeedi
Street address
North Amirabad street
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Rezvan Hemati
Street address
Chamran highway, West Bagherkhan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
No. 1, North door of Tehran university, Poursina street, Enghelab street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
assistant professor/ Emergeny Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital , North Amiraba street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Fax
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Emegency Medicine department, Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Fax
+98 21 8863 3039
Email
m_saeedi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Saeedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Emergency Medicine department, Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)