Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil - Full Text View

Sponsor:	University of Edinburgh
Collaborator:	Lothian Health Board
Information provided by:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT00326352

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

Resource links provided by NLM:

MedlinePlus related topics: Dislocations Shoulder Injuries and Disorders

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Remifentanil hydrochloride Remifentanil Propofol

U.S. FDA Resources

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

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

ClinicalTrials.gov Identifier:	NCT00326352 History of Changes
Other Study ID Numbers:	2003/1/13
Study First Received:	May 15, 2006
Last Updated:	May 15, 2006
Health Authority:	Scotland: Scottish Executive Health Department

Keywords provided by University of Edinburgh:

Sedation
Propofol
Remifentanil
recovery

Additional relevant MeSH terms:

Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries
Midazolam
Propofol
Remifentanil
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012