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

University of Edinburgh

Status: Terminated

Conditions: Shoulder Dislocation

Treatments: Drug: Sedation with propofol and remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00326352

2003/1/13

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)