This study compares the efficacy of two combinations to reduce anterior shoulder dislocation. The subjects in this clinical trial consisted of 48 patients with anterior shoulder dislocation who were randomly assigned to midazolam/fentanyl and propofol/fentanyl groups for PSA.This study was undertaken at the emergency department of Imam Hossein Hospital (Tehran, Iran) between April and August 2011. The two groups were compared to the time interval between injection and induction of sedation (T1), duration of time from sedation to awakening (T2), the duration of time between sedation and full awareness to time, location and individuals (T3), and possible side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501236238N2
Registration date:2015-02-23, 1393/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Hamid Reza Hatamabadi
Name of organization / entity
Shahid Beheshti University of edical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 73430
Email address
hhatamabadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Propofol versus Midazolam for Procedural Sedation of Anterior Shoulder Dislocation in Emergency Department; A Randomized Clinical Trial
Public title
Propofol versus Midazolam for Procedural Sedation of Anterior Shoulder Dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria include anterior dislocation of the shoulder and over 18 years of age. The exclusion criteria include hypersensitivity to midazolam, propofol, or fentanyl; other injury (fracture around shoulder or other limb); intake of food or fluid during last 4 hours; presence of airway difficulty; sensory problems; motor problems, vascular problems, and consumption of alcohol or other recreational drug during past 6 hours.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Daneshjoo Bolvd., Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-09-20, 1391/06/30
Ethics committee reference number
1393.554
Health conditions studied
1
Description of health condition studied
Dislocation of shoulder joint
ICD-10 code
S40.0
ICD-10 code description
Contusion of shoulder and upper arm
Primary outcomes
1
Description
Success of reduction
Timepoint
after each reducing process
Method of measurement
Physical examination and X-ray
Secondary outcomes
1
Description
Complication
Timepoint
after reduction and each subsequesnt visit
Method of measurement
History, physical examination and X-ray
Intervention groups
1
Description
Fentanyl injection was initially administered at a dose of 1 µg/kg. Then, a bolus of propofol titrated (slow IV during 30 seconds) until the spontaneous eyelid close.
Category
Treatment - Drugs
2
Description
Fentanyl injection was initially administered at a dose of 1 µg/kg. Then,intravenous midazolam 2mg/kg injected slowly during 30 seconds and titrated to spontaneous eyelid closed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Dr Hamid Reza Hatamabadi
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Hatamabadi
Street address
Emam Hossein Hospital, Shahid Madani St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hamid Reza Hatamabadi
Position
Associate professor
Other areas of specialty/work
Street address
Imam Hossein hospital, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
hhatamabadi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Dr Ensieh Gafari Shad
Position
Assistant
Other areas of specialty/work
Street address
Imam Hossein hospital, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
ensieh_ghaffari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hamid Rez Hatamabadi
Position
Associate
Other areas of specialty/work
Street address
Imam Hossein hospital, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
hhatamabadi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)