Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

NCT ID: NCT00997321

Last Updated: 2012-04-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propofol

propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation

Ketamine

ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

propofol

propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation

Intervention Type DRUG

Ketamine

ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who require moderate procedural sedation with propofol in the ED

Exclusion Criteria

* age \> 17 years
* pregnant
* intoxicated
* cannot give informed consent
* allergy to ketamine or propofol
* patient will require deep procedural sedation
* ASA physical status score \> 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James R Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Miner JR, Gray RO, Bahr J, Patel R, McGill JW. Randomized clinical trial of propofol versus ketamine for procedural sedation in the emergency department. Acad Emerg Med. 2010 Jun;17(6):604-11. doi: 10.1111/j.1553-2712.2010.00776.x.

Reference Type RESULT
PMID: 20624140 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMRF062661

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ketamine Versus Propofol as ICU Sedation
NCT06243822 COMPLETED PHASE4
Ketamine and Propofol for Upper Endoscopy
NCT02295553 COMPLETED PHASE4