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

May 15, 2006 updated by: 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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to full recovery

Secondary Outcome Measures

Outcome Measure
Operating conditions
Pain or discomfort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Gordon B Drummond, FRCA, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2006

Last Update Submitted That Met QC Criteria

May 15, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003/1/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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