Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-04-30

Brief Summary

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This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

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Detailed Description

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This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation

Alfentanil

Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Group Type ACTIVE_COMPARATOR

Alfentanil

Intervention Type DRUG

Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Interventions

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Propofol

Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation

Intervention Type DRUG

Alfentanil

Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults undergoing moderate procedural sedation in the Emergency Department

Exclusion Criteria

* Age \<18 years
* Pregnancy
* Intoxication
* Cannot give informed consent
* Allergy to any of the three study medications
* ASA physical status score \> 2
* Patients who require deep procedural sedation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No