Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000220662
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
26/08/2005
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ketamine by intravenous, sublingual and oral route of administration for treatment of pain:pharmacokinetics
Scientific title
Ketmine by intravenous, sublingual and oral route of administration for treatment of pain: pharmacokinetics
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 303 0
Condition category
Condition code
Alternative and Complementary Medicine 346 346 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adminstration of oral, sublingual, intravenous ketamine for patints in acute pain.
Intervention code [1] 168 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 401 0
Drug pharmacokinetics for 8 hours after oral and sublingual routes of administration compared with intravenous
Timepoint [1] 401 0
Secondary outcome [1] 873 0
Nil
Timepoint [1] 873 0

Eligibility
Key inclusion criteria
Previously on ketamine.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coronary artery disease,hypertension,tachyarrythmias,impaired renal function,pregnancy,lactation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2005
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
1/10/2005
Date of last data collection
Anticipated
Actual
5/10/2005
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 406 0
Other Collaborative groups
Name [1] 406 0
ANZCA grant 2004
Country [1] 406 0
Primary sponsor type
Individual
Name
Professor Stephan Schug
Address
Country
Secondary sponsor category [1] 329 0
Hospital
Name [1] 329 0
Royal Perth Hospital
Address [1] 329 0
Country [1] 329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1390 0
Royal Perth Hospital
Ethics committee address [1] 1390 0
Ethics committee country [1] 1390 0
Australia
Date submitted for ethics approval [1] 1390 0
10/07/2004
Approval date [1] 1390 0
23/09/2004
Ethics approval number [1] 1390 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36290 0
Prof Stepahn Schug
Address 36290 0
UWA Anaesthesia
L2 MRF Bld. Royal Perth Hospital
Box X2213 Perth 6847
Country 36290 0
Australia
Phone 36290 0
+61 0412299025
Fax 36290 0
Email 36290 0
stepahn.schug@uwa.edu.au
Contact person for public queries
Name 9357 0
Prof Stephan Schug
Address 9357 0
University of Western Australia
2nd Floor
Medical Research Foundation Building
GPO Box X2213
Perth WA 6847
Country 9357 0
Australia
Phone 9357 0
+61 8 92240201
Fax 9357 0
Email 9357 0
stephan.schug@uwa.edu.au
Contact person for scientific queries
Name 285 0
Prof Stephan Schug
Address 285 0
Department Anaesthesia & Pain Medicine
Royal Perth Hospital
Welington Street
Perth WA 6000
Country 285 0
Australia
Phone 285 0
+61 8 92241036
Fax 285 0
+61 8 92241111
Email 285 0
stephan.schug@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.