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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326352
First Posted: May 16, 2006
Last Update Posted: May 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lothian Health Board
Information provided by:
University of Edinburgh
  Purpose
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

Condition Intervention
Shoulder Dislocation Drug: Sedation with propofol and remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Time to full recovery

Secondary Outcome Measures:
  • Operating conditions
  • Pain or discomfort

Estimated Enrollment: 40
Study Start Date: July 2003
Estimated Study Completion Date: June 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326352


Locations
United Kingdom
Royal Infirmary
Edinburgh, Midlothian, United Kingdom, EH16 4HA
Sponsors and Collaborators
University of Edinburgh
Lothian Health Board
Investigators
Principal Investigator: Gordon B Drummond, FRCA University of Edinburgh
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00326352     History of Changes
Other Study ID Numbers: 2003/1/13
First Submitted: May 15, 2006
First Posted: May 16, 2006
Last Update Posted: May 16, 2006
Last Verified: May 2006

Keywords provided by University of Edinburgh:
Sedation
Propofol
Remifentanil
recovery

Additional relevant MeSH terms:
Shoulder Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Propofol
Midazolam
Remifentanil
Morphine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action