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

Condition(s) targeted: Shoulder Dislocation

Intervention: Sedation with propofol and remifentanil (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Edinburgh

Official(s) and/or principal investigator(s):
Gordon B Drummond, FRCA, Principal Investigator, Affiliation: University of Edinburgh

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

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to full recovery

Secondary outcome:

Operating conditions

Pain or discomfort

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.

Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.

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

Royal Infirmary, Edinburgh, Midlothian EH16 4HA, United Kingdom

Related publications:

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.

Starting date: July 2003
Ending date: June 2005
Last updated: May 15, 2006