FracturesNCT00137085
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
A study testing ketamine in people with Fractures and Dislocations, run by Queen's University at 1 site in Canada.
Trial summary
We, the investigators at Queen's University, propose to conduct a randomized, double-blind, feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency Department procedural sedation with propofol. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Fractures, Dislocations, Abscess
- What is being tested?
- ketamine
- How many people
- 124 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals presenting or referred to the Emergency Department at Kingston General Hospital with a fracture or dislocation requiring manipulation under procedural sedation; or abscess requiring incision and drainage under procedural sedation.
- Ability to provide informed consent according to institutional requirements.
- Ability to comprehend and communicate in English.
Who cannot join
- Age < 14 or > 65 years
- Any history of significant active cardiac, pulmonary, hepatic or renal disease, as determined by patient history, chart review, or emergency physician.
- American Society of Anesthesiology (ASA) classification greater than class II.
- Body mass > 130 kg.
- A history of physician-diagnosed obstructive sleep apnea.
- Chronic use of opioids including methadone and buprenorphine.
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- A self-reported history of recent substance abuse or prior opioid dependence.
- Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
- A history of psychotic disorders, as reported by subjects or identified on review of the medical records.
- A known history of allergy or sensitivity to any study medication.
Trial locations and contacts
1 site in 1 country.
About this study
We, the investigators at Queen's University, propose to conduct a randomized, double-blind, feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency Department procedural sedation with propofol. The outcomes of interest will be safety, with respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine may be a safer and more efficacious alternative to fentanyl when used as an adjunct to propofol-assisted procedural sedation.
Read the detailed description
This initial, single-centre feasibility study will have the following specific objectives:
- Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency department procedural sedation, with respect to safety and efficacy parameters;
- Pilot of a blinded emergency department sedation and analgesia protocol, including drug doses, concealment techniques, and data collection tools, to determine the feasibility of a subsequent larger, multi-centre trial;
- Determination of the true incidence of the primary outcome measures in the study population, using the study drug administration doses and protocol, such that an accurate sample size may be estimated for a future, adequately-powered, multi-centre trial;
- Validation of a newly-developed ordered, categorical rating scale for the reporting of respiratory and hemodynamic adverse events occurring during emergency department procedural sedation and analgesia.
- Conditions
- Fractures, Dislocations, Abscess, Anesthesia, Analgesia
- Being tested
- ketamine
- Keywords
- procedural sedation
- Medical subject headings
- Fractures, Bone, Joint Dislocations, Abscess, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest in this study will be the incidence and severity of adverse events during procedural sedation, characterized by using an ordered, four-point categorical scale of airway, ventilatory and hemodynamic adverse events.
Secondary outcomes (7)
The secondary outcome measures of this study will be: the incidence and type of individual adverse events listed in the primary outcome
the dose of propofol administered during the procedure
times from study drug administration to: beginning of procedure, end of procedure, recovery of appropriate verbal response, Emergency Department discharge, incidence of any adverse event(s)
successful completion of the procedure
the operator's rating of the sedation
incidence of any adverse drug reaction
patient visual analogue scale (VAS) ratings of analgesia, amnesia, and general satisfaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startSep 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 124 participants
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Marco LA Sivilotti, MD, MSc, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137085
- Sponsor's protocol ID
- PSI R04-43
- Status last verified
- Apr 2006
- First submitted
- 26 Aug 2005
- Last updated
- 14 Jun 2007
- Results posted
- No
Publications
Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.
PubMed 18754820
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
- ClinicalTrials.gov ID
- NCT00137085
- Acronym / sponsor ID
- PSI R04-43
- Conditions
- Fractures, Dislocations, Abscess, Anesthesia, Analgesia
- Keywords
- procedural sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Sep 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We, the investigators at Queen's University, propose to conduct a randomized, double-blind, feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency Department procedural sedation with propofol. The outcomes of interest will be safety, with respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine may be a safer and more efficacious alternative to fentanyl when used as an adjunct to propofol-assisted procedural sedation.
Detailed description
This initial, single-centre feasibility study will have the following specific objectives:
- Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency department procedural sedation, with respect to safety and efficacy parameters;
- Pilot of a blinded emergency department sedation and analgesia protocol, including drug doses, concealment techniques, and data collection tools, to determine the feasibility of a subsequent larger, multi-centre trial;
- Determination of the true incidence of the primary outcome measures in the study population, using the study drug administration doses and protocol, such that an accurate sample size may be estimated for a future, adequately-powered, multi-centre trial;
- Validation of a newly-developed ordered, categorical rating scale for the reporting of respiratory and hemodynamic adverse events occurring during emergency department procedural sedation and analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals presenting or referred to the Emergency Department at Kingston General Hospital with a fracture or dislocation requiring manipulation under procedural sedation; or abscess requiring incision and drainage under procedural sedation.
- Ability to provide informed consent according to institutional requirements.
- Ability to comprehend and communicate in English.
Key exclusion criteria (10 listed)
- Age < 14 or > 65 years
- Any history of significant active cardiac, pulmonary, hepatic or renal disease, as determined by patient history, chart review, or emergency physician.
- American Society of Anesthesiology (ASA) classification greater than class II.
- Body mass > 130 kg.
- A history of physician-diagnosed obstructive sleep apnea.
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 |
|---|---|---|
| ketamine | Drug | – |
Primary outcome
The primary outcome of interest in this study will be the incidence and severity of adverse events during procedural sedation, characterized by using an ordered, four-point categorical scale of airway, ventilatory and hemodynamic adverse events.
7 secondary outcomes
The secondary outcome measures of this study will be: the incidence and type of individual adverse events listed in the primary outcome
the dose of propofol administered during the procedure
times from study drug administration to: beginning of procedure, end of procedure, recovery of appropriate verbal response, Emergency Department discharge, incidence of any adverse event(s)
successful completion of the procedure
the operator's rating of the sedation
incidence of any adverse drug reaction
patient visual analogue scale (VAS) ratings of analgesia, amnesia, and general satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
- Derived from this study: PubMed 18754820Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.
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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.
Marco LA Sivilotti, MD, MSc principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine in people with Fractures and Dislocations, run by Queen's University at 1 site in Canada.
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 3 inclusion and 10 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 14 Jun 2007. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of interest in this study will be the incidence and severity of adverse events during procedural sedation, characterized by using an ordered, four-point categorical scale of airway, ventilatory and hemodynamic adverse events.. 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 NCT00137085, 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 14 Jun 2007.