Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000126213
Ethics application status
Approved
Date submitted
8/01/2009
Date registered
20/02/2009
Date last updated
20/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacokinetics of 0.25% levobupivacaine with clonidine following caudal epidural administration in children
Scientific title
A non-randomised single group study on the pharmokinetics of 0.25% levobupivacaine with clonidine administered caudally in children undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated. 4176 0
Condition category
Condition code
Anaesthesiology 4385 4385 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will recieve 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with clonidine 2mcg/mL, via the caudal route, under general anaesthesia
Intervention code [1] 3895 0
Treatment: Drugs
Comparator / control treatment
Not applicable as this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5265 0
To establish the pharmacokinetics of levobupivacaine via the caudal route, when administered with clonidine. We will obtain up to 5 blood samples per patient and the samples will be batch-analysed for serum levobupivacaine levels at the Biochemistry laboratory at the Royal Melbourne Hospital. NONMEM population pharmacokinetic modelling will be used to analyse this data.
Timepoint [1] 5265 0
10, 20, 60, 90, >120 minutes post-injection
Secondary outcome [1] 8878 0
N/A
Timepoint [1] 8878 0
N/A

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Children aged under 18 years.
2. Subumbilical surgery planned.
3. Caudal analgesia with levobupivacaine and clonidine regarded as acceptable standard of care by treating anaesthetist (or by independent anaesthetist where conflict of interest arises between research and treating anaesthetist)
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Caudal analgesia refused by parent/guardian.
2. Allergy to levobupivacaine/drug solution excipients.
3. Administration of levobupivacaine or clonidine via any route in 72 hours prior to, or any extra administration during, the study period.

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 3
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4355 0
Hospital
Name [1] 4355 0
Royal Children's Hospital
Country [1] 4355 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road,
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 3920 0
None
Name [1] 3920 0
Address [1] 3920 0
Country [1] 3920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6408 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 6408 0
Flemington Road,
Parkville
Victoria 3052
Ethics committee country [1] 6408 0
Australia
Date submitted for ethics approval [1] 6408 0
Approval date [1] 6408 0
12/11/2008
Ethics approval number [1] 6408 0
28102

Summary
Brief summary
The aim of this study is to determine how clonidine affects the absorption of levobupivacaine in children having caudal anaesthesia for sub-umbilical surgery. Our study hypothesis is that the absorption of levobupivacaine will be affected when administered in conjunction with clonidine via the caudal route.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35077 0
Address 35077 0
Country 35077 0
Phone 35077 0
Fax 35077 0
Email 35077 0
Contact person for public queries
Name 12424 0
Dr George Chalkiadis
Address 12424 0
Department of Anaesthesia and Pain Management, Royal Children's Hospital
Flemington Road,
Parkville
Victoria 3052
Country 12424 0
Australia
Phone 12424 0
+61 3 9345 5233
Fax 12424 0
+61 3 9345 6003
Email 12424 0
george.chalkiadis@rch.org.au
Contact person for scientific queries
Name 3352 0
Dr George Chalkiadis
Address 3352 0
Department of Anaesthesia and Pain Management, Royal Children's Hospital
Flemington Road,
Parkville
Victoria 3052
Country 3352 0
Australia
Phone 3352 0
+61 3 9345 5233
Fax 3352 0
+61 3 9345 6003
Email 3352 0
george.chalkiadis@rch.org.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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