Comparison of Sedation/Analgesia: Midazolam/Morphine Vs P... | NCT00326352

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

NCT00326352

Sponsor

University of Edinburgh

Status

Terminated

Last Update Posted

May 16, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Shoulder Dislocation

Interventions

Sedation with propofol and remifentanil

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

May 15, 2006

First Submission Date that Met QC Criteria

May 15, 2006

First Posted Date

May 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2006

Last Update Posted Date

May 16, 2006Estimated

Name	Class
NHS Lothian	OTHER_GOV

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Sedation with propofol and remifentanil	Drug

Measure	Description	Time Frame
Time to full recovery

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gordon B Drummond, FRCA	University of Edinburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Infirmary		Edinburgh	Midlothian	EH16 4HA	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16373806	Background	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. doi: 10.1136/emj.2004.021410.

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

ID	Term
D015742	Propofol
D000077208	Remifentanil