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Trial registered on ANZCTR


Registration number
ACTRN12609000845235
Ethics application status
Approved
Date submitted
29/09/2009
Date registered
30/09/2009
Date last updated
27/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in children
Scientific title
A non-randomised single group study on the pharmokinetics of 0.25% levobupivacaine with adrenaline administered caudally in children undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated
Secondary ID [1] 284170 0
Nil
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. 251936 0
Condition category
Condition code
Anaesthesiology 252118 252118 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with adrenaline 5 mcg/mL via the caudal route, under general anaesthesia. This will be administered as a single shot caudal.
Intervention code [1] 241355 0
Treatment: Drugs
Comparator / control treatment
Not applicable as this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253000 0
To establish the pharmacokinetics of levobupivacaine via the caudal route, when administered with adrenaline. We will obtain up to 6 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] 253000 0
5, 10, 20, 30, 60, >90 minutes post-injection
Secondary outcome [1] 257769 0
N/A
Timepoint [1] 257769 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 adrenaline 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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: 1. Caudal analgesia refused by parent/guardian. 2. Allergy to levobupivacaine/drug solution excipients. 3. Administration of levobupivacaine or adrenaline 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243815 0
Hospital
Name [1] 243815 0
Royal Children's Hospital
Address [1] 243815 0
Flemington Road
Parkville, Victoria, 3052
Country [1] 243815 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 237165 0
None
Name [1] 237165 0
Address [1] 237165 0
Country [1] 237165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243946 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 243946 0
Flemington Road, Parkville Victoria 3052
Ethics committee country [1] 243946 0
Australia
Date submitted for ethics approval [1] 243946 0
24/08/2009
Approval date [1] 243946 0
19/11/2009
Ethics approval number [1] 243946 0
29101

Summary
Brief summary
The aim of this study is to determine how adrenaline 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 adrenaline via the caudal route.
Trial website
Trial related presentations / publications
Chalkiadis GA, Abdullah F, Bjorksten AR, Clarke A, Cortinez LI, Udayasiri S, Anderson BJ. Absorption characteristics of epidural levobupivacaine with adrenaline and clonidine in children. Paediatr Anaesth. 2013 Jan;23(1):58-67.
Public notes

Contacts
Principal investigator
Name 30339 0
Dr George Chalkiadis
Address 30339 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 30339 0
Australia
Phone 30339 0
+61393455233
Fax 30339 0
Email 30339 0
george.chalkiadis@rch.org.au
Contact person for public queries
Name 13586 0
Dr Dr George Chalkiadis
Address 13586 0
Department of Anaesthesia and Pain Management, Royal Children's Hospital
Flemington Road,
Parkville
Victoria 3052
Country 13586 0
Australia
Phone 13586 0
+61 3 9345 5233
Fax 13586 0
+61 3 9345 6003
Email 13586 0
george.chalkiadis@rch.org.au
Contact person for scientific queries
Name 4514 0
Dr Dr George Chalkiadis
Address 4514 0
Department of Anaesthesia and Pain Management, Royal Children's Hospital
Flemington Road,
Parkville
Victoria 3052
Country 4514 0
Australia
Phone 4514 0
+61 3 9345 5233
Fax 4514 0
+61 3 9345 6003
Email 4514 0
george.chalkiadis@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary