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Trial registered on ANZCTR


Registration number
ACTRN12611000985987
Ethics application status
Approved
Date submitted
9/09/2011
Date registered
15/09/2011
Date last updated
15/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Local Anaesthetic Use in Dental General Anaesthetics on Paediatric Patients undergoing tooth extraction.
Scientific title
Local Anaesthetic Use in Dental General Anaesthetics on Paediatric Patients undergoing tooth extraction and their reported post operative pain.
Secondary ID [1] 263010 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whether the use of Local Anaesthetic for primary teeth dental extractions under general anaesthetics is beneficial for child patients. 270739 0
Condition category
Condition code
Anaesthesiology 270916 270916 0 0
Pain management
Oral and Gastrointestinal 270919 270919 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All children undergoing tooth extraction under general anaesthetic, if in the intervention group will have lignocaine administered prior to extraction. The lignocaine will be given lingually or buccally and all children to a maximum of 7mg/kg. The actual amount will depend on the number of teeth being extracted. All children will receive Gas induction and intra operative pain relief- Sevofluorane/Nitrous Oxide, Propofol 2mg/kg, Fentanyl 10mcg/kg, Morphine: 0.1mg/kg and Diclofenac: 1mg/kg
A patients post operative pain and distress will be compared between the groups using the FLACC Paediatric Pain scale.
Intervention code [1] 269358 0
Treatment: Drugs
Comparator / control treatment
All children will be treated under general anaesthetic whether having local anaesthetic or not. Children receiving standard local anaesthetic as is standard treatment at the moment will be compared to the children receiving no local anaesthetic for their teeth extractions. There is no seperate control group.
Control group
Active

Outcomes
Primary outcome [1] 279585 0
FLACC score comparison
Timepoint [1] 279585 0
Immediately post treatment until the child leaves the day stay unit.
Secondary outcome [1] 287967 0
Post operative pain using the FLACC: behavioural scale for scoring Paediatric Pain in young children.
Timepoint [1] 287967 0
Two days after operation

Eligibility
Key inclusion criteria
Child requiring extraction under GA
I or II
Consent
Minimum age
1 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non consent
No extractions required
ASA III+

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3832 0
New Zealand
State/province [1] 3832 0

Funding & Sponsors
Funding source category [1] 269816 0
Hospital
Name [1] 269816 0
Hutt Valley DHB
Country [1] 269816 0
New Zealand
Primary sponsor type
Hospital
Name
Dental Department, Hutt Valley DHB
Address
High Street
Lower Hutt
5040
Country
New Zealand
Secondary sponsor category [1] 268848 0
None
Name [1] 268848 0
Address [1] 268848 0
Country [1] 268848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271784 0
Upper South B Ethics Committee
Ethics committee address [1] 271784 0
Ethics committee country [1] 271784 0
New Zealand
Date submitted for ethics approval [1] 271784 0
Approval date [1] 271784 0
Ethics approval number [1] 271784 0

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

Contacts
Principal investigator
Name 33135 0
Address 33135 0
Country 33135 0
Phone 33135 0
Fax 33135 0
Email 33135 0
Contact person for public queries
Name 16382 0
Dr Erin Mahoney
Address 16382 0
Dental Department
Hutt Valley DHB
High Street
Lower Hutt
5040
Country 16382 0
New Zealand
Phone 16382 0
+64 4 570 9298
Fax 16382 0
Email 16382 0
erin.mahoney@huttvalleydhb.org.nz
Contact person for scientific queries
Name 7310 0
Dr Erin Mahoney
Address 7310 0
Dental Department
Hutt Valley DHB
High Street
Lower Hutt
5040
Country 7310 0
New Zealand
Phone 7310 0
+64 4 570 9298
Fax 7310 0
Email 7310 0
erin.mahoney@huttvalleydhb.org.nz

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.