Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint in acute emergency department of Ahvaz Imam Khomeini and Golestan hospitals
Objective: comparison the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint.
Design: double center single blind randomized clinical trial
Randomization: Patients will allocate to two equal groups of intervention and control according to table of random numbers.
Participants including major eligibility criteria: this study will conduct on 40 patients with anterior dislocation of shoulder joint in Ahvaz Imam Khomeini and Gholestan hospitals. Main inclusion criteria include age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time and main exclusion criteria include decrease of level of consciousness; trauma and injury of other limbs; pregnancy; addiction; disability in speaking; allergy to opioids; abnormality in vital signs such as systolic blood pressure below 90 mmHg and respiratory rate below 12 beat in minute.
Main outcome: sedation and analgesia
Intervention: patients in intervention group will receive Dexmedetomidin via intravenous with dosage of 1 micro-gram per kilogram in 10-15 minutes. Patients in control group will receive Midazolam with dosage of 0.1 milligram per kilogram via intravenous with Fentanyl in 2-3 micro-grams per kilogram in 10-15 minutes.
General information
Acronym
have no acronym
IRCT registration information
IRCT registration number:IRCT2016021726611N1
Registration date:2016-07-11, 1395/04/21
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Seyyed Javad Maleki
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613738383
Email address
maleki.sj@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint in acute emergency department of Ahvaz Imam Khomeini and Golestan hospitals
Public title
Comparing the effect of Dexmedetomidin with Midazolam-Fentanyl in sedation and analgesia in reduction of anterior dislocation of shoulder joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18-50 years; having anterior shoulder dislocation without any other trauma; having pain score of 4-10 based on visual analog score in admission time; having consciousness level in a way that has no appropriate verbal response but normal cardiovascular function.
Exclusion criteria: decrease of level of consciousness; trauma and injury of other limbs; pregnancy; addiction; disability in speaking; lack of cooperation; allergy to opioids; abnormality in vital signs such as systolic blood pressure below 90 mmHg
and respiratory rate below 12 beat in minute.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
00986135715794
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.AJUMS.REC.1394.361
Health conditions studied
1
Description of health condition studied
Dislocation of acromioclavicular joint
ICD-10 code
S43.1
ICD-10 code description
Dislocation of acromioclavicular joint
Primary outcomes
1
Description
Sedation and analgesia
Timepoint
10 minutes after intervention
Method of measurement
Questionnaire and visual analog sore
Secondary outcomes
1
Description
Side effects
Timepoint
10-15 minutes after intervention
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
Patients in intervention group will receive Dexmedetomidin via intravenous with dosage of 1 micro-gram per kilogram in 10-15 minutes.
Category
Treatment - Drugs
2
Description
Patients in control group will receive Midazolam with dosage of 0.1 milligram per kilogram via intravenous with Fentanyl in 2-3 micro-grams per kilogram in 10-15 minutes