We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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

Study design
Purpose of the study
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
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 269816 0
Name [1] 269816 0
Hutt Valley DHB
Address [1] 269816 0
High Street
Lower Hutt
Country [1] 269816 0
New Zealand
Primary sponsor type
Dental Department, Hutt Valley DHB
High Street
Lower Hutt
New Zealand
Secondary sponsor category [1] 268848 0
Name [1] 268848 0
Address [1] 268848 0
Country [1] 268848 0

Ethics approval
Ethics application status
Ethics committee name [1] 271784 0
Upper South B Ethics Committee
Ethics committee address [1] 271784 0
6 Haxelden Road
Level 1 Montgomery Watson Building
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

Brief summary
When children are having their baby teeth removed under general anaesthetic (asleep) we commonly give them an injection of local anaesthetic just before they wake up to reduce the pain they may have after their operation. Some dentists do not give the local anaesthetic because children do not like the feeling of the numbness when they wake up and the numbness feeling can be quite distressing for children. All children while they are asleep are given pain medicine such as Panadol or morphine regardless of whether they get injections or not. For the children in this study we are going to use local anaesthetic in some patients and not in others and the parents and the nurses are going to determine if the children like having or not having the local anaesthetic. We expect the children will like not having the numbness feeling and the pain relief provided by the doctors (anaesthetists) while asleep will keep the children comfortable.
Trial website
Trial related presentations / publications
Public notes

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
Country 16382 0
New Zealand
Phone 16382 0
+64 4 570 9298
Fax 16382 0
Email 16382 0
Contact person for scientific queries
Name 7310 0
Dr Erin Mahoney
Address 7310 0
Dental Department
Hutt Valley DHB
High Street
Lower Hutt
Country 7310 0
New Zealand
Phone 7310 0
+64 4 570 9298
Fax 7310 0
Email 7310 0

No information has been provided regarding IPD availability
Summary results
No Results