Trial Review

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
ACTRN12605000608662
Ethics application status
Approved
Date submitted
3/10/2005
Date registered
6/10/2005
Date last updated
6/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine - Investigate the Dose Study
Scientific title
Pharmacodynamics of Ketamine in Children during emergency medical procedures.
Secondary ID [1] 189 0
Auckland District Health Board: A+3166
Universal Trial Number (UTN)
Trial acronym
KIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, sedation and distress during emergency medical procedures. 739 0
Condition category
Condition code
Other 815 815 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pharmacodynamic study of Ketamine 1mg/kg
Intervention code [1] 691 0
Treatment: Drugs
Comparator / control treatment
Pain, sedation and distress.
Control group

Outcomes
Primary outcome [1] 1047 0
Ketamine concentration at peak, during the procedure and after the procedure.
Timepoint [1] 1047 0
Measured at peak (5 minutes), during the procedure (approximately 30 minutes) and after the procedure.
Secondary outcome [1] 1948 0
Behavioural Measures of Distress - Wisconsin Sedation Scale
Timepoint [1] 1948 0
Measured at same time as Ketamine levels.
Secondary outcome [2] 1949 0
Visual Analog Scale
Timepoint [2] 1949 0
Measured at same time as Ketamine levels.
Secondary outcome [3] 1950 0
Observer Scale of Behavioural Distress.
Timepoint [3] 1950 0
Measured at same time as Ketamine levels.

Eligibility
Key inclusion criteria
All children suitable for Ketamine sedation as per Auckland Starship Childrens hospital guidelines.
Minimum age
Not stated
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 240 0
New Zealand
State/province [1] 240 0

Funding & Sponsors
Funding source category [1] 904 0
Other Collaborative groups
Name [1] 904 0
Royal Australasian College of Physicians
Country [1] 904 0
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 763 0
University
Name [1] 763 0
University of Auckland
Address [1] 763 0
Country [1] 763 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2187 0
New Zealand Northern Regional X
Ethics committee address [1] 2187 0
Ethics committee country [1] 2187 0
New Zealand
Date submitted for ethics approval [1] 2187 0
Approval date [1] 2187 0
Ethics approval number [1] 2187 0

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

Contacts
Principal investigator
Name 35579 0
Address 35579 0
Country 35579 0
Phone 35579 0
Fax 35579 0
Email 35579 0
Contact person for public queries
Name 9880 0
David Herd
Address 9880 0
54 Woodside Ave
Northcote
Auckland 1310
Country 9880 0
New Zealand
Phone 9880 0
+64 9 4805721
Fax 9880 0
+64 9 4805721
Email 9880 0
[email protected]
Contact person for scientific queries
Name 808 0
David Herd
Address 808 0
54 Woodside Ave
Northcote
Auckland 1310
Country 808 0
New Zealand
Phone 808 0
+64 9 4805721
Fax 808 0
+64 9 4805721
Email 808 0
[email protected]

No information has been provided regarding IPD availability


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.