Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
NCT ID: NCT01260662
Last Updated: 2015-07-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
271 participants
INTERVENTIONAL
2010-11-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)
NCT00997321
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
NCT02404610
Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial
NCT01269307
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
NCT00997126
Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults
NCT01544725
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Propofol
Deep sedation using propofol
Propofol
1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation
1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation
4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Propofol
1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hennepin Healthcare Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Miner JR, Moore JC, Austad EJ, Plummer D, Hubbard L, Gray RO. Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. Ann Emerg Med. 2015 May;65(5):479-488.e2. doi: 10.1016/j.annemergmed.2014.08.046. Epub 2014 Oct 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSR 10-3230
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.