Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000235000
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
22/03/2010
Date last updated
29/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of topical lignocaine on the incidence of perioperative respiratory complications in children undergoing laryngo-tracheo-bronchoscopies – a double blind randomised controlled pilot study
Scientific title
Impact of topical lignocaine on the incidence of perioperative respiratory complications in children undergoing laryngo-tracheo-bronchoscopies – a double blind randomised controlled pilot study
Secondary ID [1] 1514 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory complications following topical lignocaine onto the vocal cords for laryngotracheobronchoscopies 256959 0
Condition category
Condition code
Anaesthesiology 257102 257102 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical lignocaine vs. placebo onto vocal cords for a laryngo-tracheo-bronchoscopy.
The lignocaine is applied directly following induction of anaesthesia. It is only applied once which takes one spray of lignocaine of 5-10 seconds duration.
The lignocaine dose used will be a maximum of 4 mg/kg as topical spray (under vision) onto the vocal cords. For this trial, lignocaine 4% will be used in all children. In children > 30 kg 3 ml of lignocaine 4% will be applied.
Intervention code [1] 256136 0
Prevention
Comparator / control treatment
Saline.
The saline is sprayed as a once off spray (identical to lignocaine) directly following induction of anaesthesia. The application of the spray takes approx. 5-10 seconds.
The control group will receive the equivalent amount of normal saline in ml as compared to the lignocaine dose
Control group
Placebo

Outcomes
Primary outcome [1] 257997 0
the total of respiratory complications intraoperatively and postoperatively.
Assessment by clinical examination and monitoring
Timepoint [1] 257997 0
intraoperatively plus during the stay in the recovery room area
Secondary outcome [1] 263551 0
the occurrence of the individual respiratory complication.
Assessment by clinical examination and monitoring
Timepoint [1] 263551 0
intraoperatively plus during the stay in the recovery room area

Eligibility
Key inclusion criteria
Children, aged 0 to 16 years, male or female undergoing an laryngo-tracheo-bronchoscopy (LTB).
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity to lignocaine, airway reconstruction surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written voluntary consent consisting of parental permission and also child assent when applicable, will be obtained and great care will be taken to maintain the highest standards regarding consent for clinical research in paediatric anaesthesia. The children will be included into the trial at the preanaesthetic visit. Following inclusion into the study protocol, the children will be randomly assigned to group “lignocaine” or group “saline” by computer generated block randomisation. The anaesthetist in charge, the ENT surgeon and the recovery staff will be blinded to the substance used to spray on the cords (lignocaine vs saline). Allocation was concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2010
Actual
18/11/2009
Date of last participant enrolment
Anticipated
Actual
20/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3853 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 256639 0
Hospital
Name [1] 256639 0
Princess Margaret Hospital for Children
Country [1] 256639 0
Australia
Primary sponsor type
Individual
Name
Prof Britta Regli-von Ungern-Sternberg
Address
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 255926 0
Individual
Name [1] 255926 0
Dr Tim Cooney
Address [1] 255926 0
Princess Margaret Hospital for Children
Department of Ear-Nose and Throat Surgery
Roberts Road
Subiaco, WA 6008
Country [1] 255926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292933 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 292933 0
Roberts Road
Subiaco
WA 6008
Ethics committee country [1] 292933 0
Australia
Date submitted for ethics approval [1] 292933 0
01/07/2009
Approval date [1] 292933 0
20/08/2009
Ethics approval number [1] 292933 0
1640 EP

Summary
Brief summary
the purpose of this study is to characterize the modification induced by lignocaine on the incidence of intraoperative and postoperative respiratory complications in children undergoing laryngo tracheo bronchoscopies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30925 0
Prof Britta Regli-von Ungern-Sternberg
Address 30925 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital
Roberts Road,
Subiaco
WA 6008
Country 30925 0
Australia
Phone 30925 0
+61893408109
Fax 30925 0
Email 30925 0
[email protected]
Contact person for public queries
Name 14172 0
Prof Britta Regli-von Ungern-Sternberg
Address 14172 0
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country 14172 0
Australia
Phone 14172 0
+61893408109
Fax 14172 0
+61893408755
Email 14172 0
[email protected]
Contact person for scientific queries
Name 5100 0
Prof Britta Regli-von Ungern
Address 5100 0
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country 5100 0
Australia
Phone 5100 0
+61893408109
Fax 5100 0
Email 5100 0
[email protected]

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.