Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000842268
Ethics application status
Approved
Date submitted
22/09/2009
Date registered
29/09/2009
Date last updated
29/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Observational study assessing the laryngeal and pharyngeal spread of topical local anaesthetic administered orally during general anaesthesia in children
Scientific title
Observational study assessing the laryngeal and pharyngeal spread of topical local anaesthetic administered orally during general anaesthesia in children
Universal Trial Number (UTN)
U1111-1111-9650
Trial acronym
Topical anaesthesia of the paediatric airway (TAPA)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients having general anaesthetic 251895 0
Condition category
Condition code
Anaesthesiology 252070 252070 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study to assess the spread of local anaesthetic solution throughout the pharynx and larynx.

Children having a general anaesthetic requiring a tracheal tube will have local anaesthetic poured into the back of the mouth. The local anaesthetic will be stained with methylene blue dye, so that the investigator is able to determine which parts of the patient have come into contact with the local anaesthetic.

The study is expected to be completed within two years.
Intervention code [1] 241324 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 252964 0
Complete staining of laryngeal structures with methylene blue stained local anaesthetic solution
Timepoint [1] 252964 0
Within 10 minutes of induction of anaesthesia
Secondary outcome [1] 257702 0
Adverse events during induction of anaesthesia including: coughing, laryngospasm (spasm of vocal cords), reduced oxygen saturation of blood, reduced heart rate.

These will be assessed by the investigator present by observation of the patient and monitoring equipment during approximately 10 minutes after induction of anaesthesia.
Timepoint [1] 257702 0
Within 10 minutes of induction of anaesthesia

Eligibility
Key inclusion criteria
Healthy children undergoing elective surgery requiring tracheal intubation
Minimum age
6 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American Society of Anesthesiologists (ASA) grade 3 and above (patients with significant medical problems)

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243772 0
Other
Name [1] 243772 0
Melbourne Royal Children's Hospital Anaesthetic department research fund
Country [1] 243772 0
Australia
Primary sponsor type
Hospital
Name
Royal Childerns Hospital, Melbourne
Address
Royal Childerns Hospital
50 Flemington Rd
Parkville VIC 3052
Melbourne
Country
Australia
Secondary sponsor category [1] 237131 0
None
Name [1] 237131 0
Address [1] 237131 0
Country [1] 237131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243902 0
Royal Childrens Hospital Melbourne
Ethics committee address [1] 243902 0
Ethics committee country [1] 243902 0
Australia
Date submitted for ethics approval [1] 243902 0
15/12/2007
Approval date [1] 243902 0
15/01/2008
Ethics approval number [1] 243902 0
28010

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

Contacts
Principal investigator
Name 30314 0
Address 30314 0
Country 30314 0
Phone 30314 0
Fax 30314 0
Email 30314 0
Contact person for public queries
Name 13561 0
richard beringer
Address 13561 0
department of anaesthesia
bristol royal hospital for children
upper maudlin street
bristol
bs2 8bj
Country 13561 0
United Kingdom
Phone 13561 0
+44 7590665250
Fax 13561 0
Email 13561 0
richard.beringer@uhbristol.nhs.uk
Contact person for scientific queries
Name 4489 0
richard beringer
Address 4489 0
department of anaesthesia
bristol royal hospital for children
upper maudlin street
bristol
bs2 8bj
Country 4489 0
United Kingdom
Phone 4489 0
+44 7590665250
Fax 4489 0
Email 4489 0
richard.beringer@uhbristol.nhs.uk

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 320635-(Uploaded-09-12-2019-23-44-25)-Basic results summary.pdf
Plain language summaryNo See paper attached
Study results articleYes Pediatric Anesthesia

Documents added automatically
No additional documents have been identified.