To compare the effects of intravenous sedation with midazolam/fentanyl and thiopental/ fentanyl for orthopedic procedures of upper extremities. Population of this study are patients with age range between 15 and 60 years old from both sex who have dislocation of shoulder joint or fracture of radius. For this study according to sample size measurement, we need 92 patients. Multiple trauma or fractures, history of allergic reaction to study drugs will be excluded from this study. We will perform a randomized clinical trial in Hazrat Rasoul Akram and Sina hospitals. All the patients who fulfill the inclusion criteria would be randomly allocated to one of the study groups. In each group, under cardiac monitoring, pulse oximetery and non invasive blood pressure control drugs with recommended doses will be used. Time of drug injection, beginning and duration of sedation, recovery time, satisfaction of the physician who perform the procedure and side effects will be recorded. SPSS software will be used for analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110307751N2
Registration date:2012-04-17, 1391/01/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-17, 1391/01/29
Registrant information
Name
Davood Farsi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
dfarsi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous sedation with midazolam/fentanyl and thiopental/ fentanyl for orthopedic procedures of upper extremities
Public title
Comparison of midazolam/fentanyl and thiopental/ fentanyl for fracture and dislocation reduction of upper arm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Orthopedic injuries of upper extremities in 15-60 years old patients with American Society of Anesthesiologist (ASA) Classification Score 1& 2
Exclusion criteria: Pregnancy, multiple trauma or fractures, history of allergic reaction to study drugs,or asthma, heart failure, porphyria, mental disorders or psychosis
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Tehran university of medical sciences
City
Tehran
Postal code
1445613131
Approval date
2012-02-26, 1390/12/07
Ethics committee reference number
2343
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
Fracture of lower end of both ulna and radius
ICD-10 code
S52/6
ICD-10 code description
Fracture of lower end of both ulna and radius
Primary outcomes
1
Description
pain score
Timepoint
before procuder,on time procuder,5 minut after procuder,15 minut after procuder
Method of measurement
numeric rating scale
Secondary outcomes
1
Description
BP
Timepoint
Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure
Method of measurement
Osillometry
2
Description
SaO2
Timepoint
Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure
Method of measurement
Puls oxymetry
3
Description
HR
Timepoint
Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure
Method of measurement
Cardiac monitoring
4
Description
Pain
Timepoint
Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure
Method of measurement
Numeric rating scale
Intervention groups
1
Description
In control group thiopental (2 mg/kg) and fentanyl (1.5 mg/kg) is used and compared with midazolam (0.1-0.5 mg/kg) and fentanyl (1.5 mg/kg). In case of needing additional doses, half of the first dose is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital and Hazrate Rasol Hospital
Full name of responsible person
Dr Davood Farsi
Street address
Hazrate Rasol Hospital, Niayesh Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Universty of Medical Sciences
Full name of responsible person
Dr Akhondzadeh Shahin
Street address
Tehran Universty of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?