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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00326352
Enrollment
40
Registered
2006-05-16
Start date
2003-07-31
Completion date
2005-06-30
Last updated
2006-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Keywords

Sedation, Propofol, Remifentanil, recovery

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.

Interventions

DRUGSedation with propofol and remifentanil

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to full recovery

Secondary

MeasureTime frame
Operating conditions
Pain or discomfort

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026