Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
Primary Purpose
Shoulder Dislocation
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sedation with propofol and remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Dislocation focused on measuring Sedation, Propofol, Remifentanil, recovery
Eligibility Criteria
Inclusion Criteria: - Anterior dislocation of the shoulder suitable for manual reduction Exclusion Criteria: significant other illness body weight 25% greater than expected fear of oxygen masks alcohol intoxication
Sites / Locations
- Royal Infirmary
Outcomes
Primary Outcome Measures
Time to full recovery
Secondary Outcome Measures
Operating conditions
Pain or discomfort
Full Information
NCT ID
NCT00326352
First Posted
May 15, 2006
Last Updated
May 15, 2006
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT00326352
Brief Title
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
Official Title
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Terminated
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
5. Study Description
Brief Summary
For reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam
Detailed Description
Propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. We intend to provide sedation with propofol, 0.5 mg/Kg, and analgesia with remifentanil 0.5 microgram/Kg for reduction of dislocated shoulders. This will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/Kg, and morphine incrementally up to 0.15 mg/Kg. The primary outcome measure is time to full recovery. Secondary aspects are pain or discomfort during the procedure and operating conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Sedation, Propofol, Remifentanil, recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sedation with propofol and remifentanil
Primary Outcome Measure Information:
Title
Time to full recovery
Secondary Outcome Measure Information:
Title
Operating conditions
Title
Pain or discomfort
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Anterior dislocation of the shoulder suitable for manual reduction
Exclusion Criteria:
significant other illness
body weight 25% greater than expected
fear of oxygen masks
alcohol intoxication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon B Drummond, FRCA
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4HA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
16373806
Citation
Dunn MJ, Mitchell R, Souza CD, Drummond G. Evaluation of propofol and remifentanil for intravenous sedation for reducing shoulder dislocations in the emergency department. Emerg Med J. 2006 Jan;23(1):57-8. doi: 10.1136/emj.2004.021410.
Results Reference
background
Learn more about this trial
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
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