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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Shoulder Dislocation
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT00326352
Primary Trial ID Number
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
Research Details
  • 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.
Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Sedation with propofol and remifentanil
Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to full recovery; null
Secondary Outcome Measures
  • Operating conditions; null; Pain or discomfort; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
16 Years - 65 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Royal Infirmary
Edinburgh
Midlothian
EH16 4HA
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
EudraCT Number
Not available for this trial
Funder(s)
  • Lothian Health Board
Other Study ID Numbers
2003/1/13
Sponsor(s)
University of Edinburgh
Key Dates

Recruitment Start Date

Jul 2003

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

15 May 2006

Last Updated

15 May 2006