The Comparison of intravenous Midazolam, Fentanyl versus intravenous Lidocain, Midazolam and Fentanyl as sedative and analgesic for the reduction of anterior shoulder dislocation in patient presented to Emergency Department
The goal of this study is comparison of intravenous Midazolam, Fentanyl versus intravenous Lidocain, Midazolam and Fentanyl as sedative and analgesic for the reduction of anterior shoulder dislocation in patient presented to Emergency Department. This study is double blind randomized clinical trial. 100 patients with anterior shoulder dislocation candidate for close reduction in Emergency Department and do not have any contraindications for administration Lidocain, Midazolam and Fentanyl were randomly divided into two groups. One will be administered intravenous Lidocain, Midazolam and Fentanyl as sedative and analgesic (intervention) and another will be administered intravenous distilled water, Midazolam and Fentanyl (control). The interventional group patients are administered 1mg/kg intravenous lidocain and the same amount of distilled water administered intravenously as a placebo for control group. In both groups midazolam and fentanyl administered intravenously and tit-rated to reach the benchmark 4 from ramsay score. Then shoulder dislocation will be reducted. Severity of pain was assessed according to Visual Analog Scale before drug administration and also after full consciousness of patient will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101730353N1
Registration date:2017-02-12, 1395/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Aida Mohammadian
Name of organization / entity
Imam Hosein hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 7069
Email address
aynaz3139@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Reserch of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of intravenous Midazolam, Fentanyl versus intravenous Lidocain, Midazolam and Fentanyl as sedative and analgesic for the reduction of anterior shoulder dislocation in patient presented to Emergency Department
Public title
The role of intravenous Lidocain as sedative and analgesic for the reduction of anterior shoulder dislocation in refereed to Emergency ward of hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with anterior shoulder dislocation
Exclusion criteria: All patients with loss of consciousness; the patient who has shoulder fracture(except hill-sachs lesion); past medical history of shoulder surgery or shoulder fracture; past medical history of epilepsy; cardiac disease or dysrhythmia drug history of using digoxin; all patient with allergy to lidocain midazolam or fentanyl
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Scinces
Street address
Tabnank St, Yaman St, Shahid Chamran highway
City
tehran
Postal code
1985717443
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
ir.sbmu.sm.rec.1394.22
Health conditions studied
1
Description of health condition studied
anterior shoulder dislocation
ICD-10 code
S43.01
ICD-10 code description
Anterior subluxation and dislocation of humerus
Primary outcomes
1
Description
severity of pain
Timepoint
before sedation and after full conciousnes
Method of measurement
according to VAS (Visual Analog Scale)
Secondary outcomes
1
Description
drug`s side effects: apnea, oxigen saturation decrease less than 90 percent, dysrhytmia, other
Timepoint
after full consciousness
Method of measurement
questionair
Intervention groups
1
Description
In control grup, after pain assesment, patients were gave 5 cc intravenus distilled water. After 5 minute the patients were gave titrate intravenus Midazolam & Fentanyl to reach 4 from ramsay score.
Category
Treatment - Drugs
2
Description
In intervention group, after pain assesment, patients were gave intravenus lidocain 1 mg per kg of patient body weight. After 5 minute the patients were gave titrate intravenus Midazolam & Fentanyl to reach 4 from ramsay score.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Immam Hosein hospital
Full name of responsible person
Ali Arhami Dolatabadi
Street address
Immam Hosein 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
Mohammad Rahmati Roodsari
Street address
Shahid Beheshti University of Medical science, Tabnak St, Yaman St, Shahid Chamran highway
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
Immam Hosein hospital
Full name of responsible person
Aida Mohammadian
Position
emergency medicine resident
Other areas of specialty/work
Street address
Imam Hosein Hospital, Shahid Madani St
City
tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
aynaz3139@gmail.comaidamohammadian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Arhami Dolatabadi
Position
Emergency medicin, Assistant professor
Other areas of specialty/work
Street address
Immam Hosein Hospital,Shahid Madani St
City
tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
ali_arhami@sbmu.ac.ir; aliarhami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical science
Full name of responsible person
Aida Mohammadian
Position
Assistant of Emergency Medicine
Other areas of specialty/work
Street address
Imam Hosein Hospital, Shahid Madani St
City
Tehran
Postal code
Phone
+98 21 2235 8282
Fax
Email
aidamohammadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)