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

Not Applicable

Terminated

• Conditions: Shoulder Dislocation

• Registration Number: NCT00326352
• Lead Sponsor: University of Edinburgh

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.

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-06
• Status Verified: 2006-05
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Last Update Submitted: 2006-05-15
• Study First Posted: 2006-05-16
• Last Update Posted: 2006-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to full recovery

Secondary Outcome Measures

Name	Time	Method
Operating conditions
Pain or discomfort

Trial Locations

Locations (1)

Royal Infirmary; 🇬🇧 Edinburgh, Midlothian, United Kingdom