NCT00326352

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
Last Updated

May 16, 2006

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

May 15, 2006

Conditions

Shoulder Dislocation

Keywords

SedationPropofolRemifentanilrecovery

Outcome Measures

Primary Outcomes (1)

  • Time to full recovery

Secondary Outcomes (2)

  • Operating conditions

  • Pain or discomfort

Interventions

Sedation with propofol and remifentanilDRUG

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Anterior dislocation of the shoulder suitable for manual reduction

You may not qualify if:

  • significant other illness
  • body weight 25% greater than expected
  • fear of oxygen masks
  • alcohol intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary

Edinburgh, Midlothian, EH16 4HA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 16373806BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

PropofolRemifentanil

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gordon B Drummond, FRCA

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 16, 2006

Study Start

July 1, 2003

Study Completion

June 1, 2005

Last Updated

May 16, 2006

Record last verified: 2006-05

Locations

GB(1)