SedationPhase 4NCT00997321

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

A Phase 4 study testing propofol and Ketamine in people with Sedation, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation
What is being tested?: propofol and Ketamine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients who require moderate procedural sedation with propofol in the ED

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department

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

Conditions: Sedation
Being tested: propofol, Ketamine
Keywords: ketamine, propofol, procedural sedation, moderate procedural sedation in the ED

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

propofolDrug
propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
KetamineDrug
ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Study groups in NCT00997321
Study group	Role	What they receive
Propofol	Active comparator	propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation Receives: Drug: propofol
Ketamine	Active comparator	ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation Receives: Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory Depression (Sub-clinical and Clinical Signs)
binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform
Measured: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)

Secondary outcomes (3)

Time to Return of Baseline Mental Status
time in seconds from the first dose of medication until the patient has regained baseline mental status
Measured: from start of procedure until the return of baseline mental status up to 120 minutes
Patient Reported Pain or Recall of the Procedure
patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question
Measured: single measurement immediately after patient returns to baseline mental status after sedation procedure
Depth of Sedation
Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain
Measured: single measurement during sedation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Oct 2009

First posted19 Oct 2009 (estimated)
Study startJul 2007
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997321
Sponsor's protocol ID: MMRF062661
Status last verified: Mar 2012
First submitted: 12 Oct 2009
Last updated: 2 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 20624140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department
ClinicalTrials.gov ID: NCT00997321
Acronym / sponsor ID: MMRF062661
Conditions: Sedation
Keywords: ketamine, propofol, procedural sedation, moderate procedural sedation in the ED
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Hennepin Healthcare Research InstituteUniversity, hospital or other
Study start: Jul 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Oct 2009 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Propofol	Active comparator	Drug: propofolpropofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation
Ketamine	Active comparator	Drug: Ketamineketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients who require moderate procedural sedation with propofol in the ED

Key exclusion criteria (7 listed)

age > 17 years
pregnant
intoxicated
cannot give informed consent
allergy to ketamine or propofol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
propofolpropofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation	Drug	Propofol
Ketamineketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation	Drug	Ketamine

Primary outcome

Respiratory Depression (Sub-clinical and Clinical Signs)
Time frame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)
binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform

3 secondary outcomes

Time to Return of Baseline Mental Status
Time frame: from start of procedure until the return of baseline mental status up to 120 minutes
Patient Reported Pain or Recall of the Procedure
Time frame: single measurement immediately after patient returns to baseline mental status after sedation procedure
Depth of Sedation
Time frame: single measurement during sedation procedure

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol	50	50
Ketamine	50	47

Primary outcome: Respiratory Depression (Sub-clinical and Clinical Signs)

Time frame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Propofol n = 50	Ketamine n = 47
Value	0.4 (0.26 to 0.55)	0.6 (0.45 to 0.74)

Population analysed: 50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol	0 of 50 (0%)	0 of 50 (0%)	Not reported
Ketamine	0 of 47 (0%)	0 of 47 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20624140Miner 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.

Related trials for Sedation

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James R Miner, MD principal investigator

Hennepin Healthcare Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing propofol and Ketamine in people with Sedation, run by Hennepin Healthcare Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Depression (Sub-clinical and Clinical Signs) (time frame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.