Clinical Trials Logo
  1. Home
  2. Shoulder Dislocation
  3. NCT00326352
  4. Details
NCT00326352 Clinical Trial

Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Shoulder Dislocation Clinical Trial

Official title:
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00326352
Other study ID # 2003/1/13
Secondary ID
Status Terminated
Phase N/A
First received May 15, 2006
Last updated May 15, 2006
Start date July 2003
Est. completion date June 2005

Study information
Verified date May 2006
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority Scotland: Scottish Executive Health Department
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sedation with propofol and remifentanil

Locations
Country Name City State
United Kingdom Royal Infirmary Edinburgh Midlothian

Sponsors (2)
Lead Sponsor Collaborator
University of Edinburgh Lothian Health Board

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to full recovery
Secondary Operating conditions
Secondary Pain or discomfort
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05635240 - Chronic Anterior Shoulder Instability in the Military
Recruiting NCT02913352 - Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation N/A
Completed NCT03154957 - Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path
Recruiting NCT02510625 - The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability N/A
Completed NCT00707018 - Immobilization in External Rotation After First Time Anterior Shoulder Dislocation N/A
Recruiting NCT04887337 - Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode N/A
Completed NCT04960137 - Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor N/A
Recruiting NCT05388942 - Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial N/A
Completed NCT02725333 - Does Shoulder Stabilizations Stabilize Shoulders? N/A
Recruiting NCT05705479 - Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial N/A
Not yet recruiting NCT05048303 - Multicenter Clinical Cohort Study of Modified Flexible Fixation Latarjet Procedure for Recurrent Shoulder Dislocation N/A
Recruiting NCT03453710 - Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability N/A
Recruiting NCT04952636 - A Prospective Comparative Study of Arthroscopic and Open Surgery in Cuistow Procedure N/A
Completed NCT00251264 - Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability N/A
Terminated NCT02426996 - The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation N/A
Completed NCT04022629 - ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial Phase 2/Phase 3
Terminated NCT04820491 - Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial N/A
Recruiting NCT05443295 - Improvement of Fatigue in Unstable Shoulder Through a Therapeutic Exercise Program in Physiotherapy N/A
Completed NCT06459258 - Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training N/A
Completed NCT04479397 - Sling vs Nothing After Latarjet Procedure N/A