Comparison of Remifentanil with Fentanyl/Midazolam for Moderate Sedation for Closed Reduction of Anterior Shoulder Dislocation in Adults in the ED: a Randomized Controlled Trial
Objective: The aim of this study is to compare the efficacy of a pure analgesia- based sedation regimen with Remifentanil with a conventional regimen consisting of Fentanyl / Midazolam for moderate sedation for reduction of anterior shoulder dislocation in adults in ED.
Setting: This study is conducted in the ED of a university-affiliated tertiary care medical center over a 9-month period between February 2, 2013 and October 23, 2013.
Design:A prospective, randomized clinical trial.
Participants:42 intent-to-treat American Society of Anesthesiologists (ASA) class I–II adult patients undergoing moderate sedation for closed shoulder reduction will be randomly allocated into two groups.
Intervention: Group 1 will receive R (1 µg/kg and repeated additional doses of 1 µg/kg/min), while those in group 2 will receive F (1.5 µg/kg) plus M (0.1 mg/kg).
Main outcome measures: Primary end-points are pain score, procedure time and patient satisfaction, and incidence of respiratory adverse events. Secondary end points included non respiratory adverse events.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011312115N1
Registration date:2014-05-11, 1393/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Hamid Zamani Moghadam
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 1221 1537
Email address
zamanimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-02-02, 1391/11/14
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Remifentanil with Fentanyl/Midazolam for Moderate Sedation for Closed Reduction of Anterior Shoulder Dislocation in Adults in the ED: a Randomized Controlled Trial
Public title
Remifentanil for Moderate Sedation for Shoulder Reduction in the ED
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA: Those aged 18–64 years with anterior shoulder dislocation, requiring closed reduction with physical condition I (healthy and normal patients without previous medical history) and II (patients with mild systemic disease with no functional limitation) according to the classification system of American Society of Anesthesiologists (ASA) will be selected.
EXCLUSION CRITERIA: The exclusion criteria included age <18 years and >64 years; History of allergy to benzodiazepines and narcotics; Prolonged use of opioids; Alcohol usage; Sleep obstructive apnea syndrome; Maxillofacial malformations with high probability of failure in maintaining the airway; Pregnant patients; Anterior dislocation requiring referral to orthopedic operating room; Patients with severe trauma; Patients in septic shock; Patients with advanced Heart disease; Kidney failure; Pneumonia; Uncontrolled seizures; Patients not willing to participate in the study.
Age
From 18 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Vice chancellor for research Mashhad Univercity of Medical Sciences, Ghoreishi building, Daneshgah avenue, Mashhad, Iran.
City
Mashhad
Postal code
91735-951
Approval date
2012-11-04, 1391/08/14
Ethics committee reference number
91/570419
Health conditions studied
1
Description of health condition studied
Anterior Shoulder Dislocation
ICD-10 code
s43.0
ICD-10 code description
Glenohumeral Joint
Primary outcomes
1
Description
Pain Perception
Timepoint
During Intervention
Method of measurement
Visual Analog Scale 100mm
2
Description
Respiratory Adverse Events
Timepoint
During Intervention
Method of measurement
The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of intravenous administration of the drug until hospital discharge
3
Description
Procedure Time
Timepoint
During Intervention
Method of measurement
From the begining of sedatiion till end of reduction
Patients in control group will recieve single dose fentanyl 1.5 microg/kg slowly via intravenous infusion over 30 seconds from the form of injection solution 0.05 mg/ml plus single dose midazolam 0.1 mg/kg slowly via intravenous infusion over 2 minutes from the form of injection solution 1 mg/ml.
Category
Treatment - Drugs
2
Description
In the intervention group the patients will receive remifentanil 1 microg/kg slowly via intravenous injection over 30 seconds and repeated doses every 1 minute titrated to effect from the form of injection,powder for reconstitution: 1mg, diluted to a final concentration of 50 microg/ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.Zamani Moghadam.H emergency medicine specialist