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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Shoulder Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sedation with propofol and remifentanil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gordon B Drummond, FRCA

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary

Edinburgh, Midlothian, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND

PMID: 16373806 (View on PubMed)

Other Identifiers

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2003/1/13

Identifier Type: -

Identifier Source: org_study_id