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Trial registered on ANZCTR


Registration number
ACTRN12612000629831
Ethics application status
Not yet submitted
Date submitted
8/06/2012
Date registered
12/06/2012
Date last updated
12/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of the throat in young children
Scientific title
A comparison of new (supine) and traditional (sitting) methods of examining the throat in children under 3 years of age presenting acutely to a paediatric service: Evaluation of tolerability and effectiveness.
Secondary ID [1] 280648 0
Nil
Universal Trial Number (UTN)
U1111-1131-6203
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute paediatric conditions 286663 0
Condition category
Condition code
Respiratory 286960 286960 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two methods of examining the throat in young children (under 3 years). Traditional method of examination involves sitting on the caregiver's lap facing the examiner with head, legs and arms restrained by the caregiver, as described in a standard paediatric textbook (Kliegman RM, Stanton BF, St. Geme JW, Schor NF, Behrman, RE (Eds). Nelson’s Textbook of Paediatrics, 19th Ed (2001) Chapter 628). The new method involves the child lying supine with head on the examiner's knees and pelvis on the caregiver's lap. This will occur as part of the normal examination routine and will take approximately 30-60 seconds in either case. It will be done only once, using one or the other of the described methods as allocated by randomisation.
Intervention code [1] 285048 0
Diagnosis / Prognosis
Comparator / control treatment
Traditional method of examination, sitting on the caregiver's lap facing the examiner with head, legs and arms restrained by the caregiver, as described in a standard paediatric textbook (Kliegman RM, Stanton BF, St. Geme JW, Schor NF, Behrman, RE (Eds). Nelson’s Textbook of Paediatrics, 19th Ed (2001) Chapter 628)
Control group
Active

Outcomes
Primary outcome [1] 287302 0
Tolerability of procedure (patient distress) rated by caregiver on a Likert scale.
Timepoint [1] 287302 0
Immediate
Primary outcome [2] 287309 0
Effectiveness of procedure (clarity of view) rated by doctor on a Likert scale
Timepoint [2] 287309 0
Immediate
Secondary outcome [1] 297861 0
Ease of examination (rated by doctor on Likerts scale)
Timepoint [1] 297861 0
Immediate
Secondary outcome [2] 297862 0
Time taken (measured by doctor)
Timepoint [2] 297862 0
Immediate
Secondary outcome [3] 297879 0
Ease of restraint (rated by caregiver on a Likert scale)
Timepoint [3] 297879 0
Immediate

Eligibility
Key inclusion criteria
Children presenting with acute medical problems where examination of the throat is clinically indicated.
Minimum age
1 Days
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Throat examination is contraindicated.
Informed consent not obtained from carer.
Seriously ill requiring urgent intervention.
Previously recruited to study during current admission.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes containing random allocation to one of the two examination methods will be nprepared for each one year age stratum. When a child is ligible for the study, the parent/guardian is approached by the paediatric doctor assessing the child, and informed consent is sought. If consent is obtained, the appropriate envelope for the child's age will be opend, and that method will be used. No blinding will be possible, but neither the doctor or parent will be aware of the allocation until after recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a random number generator (Excel function)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment outside Australia
Country [1] 4358 0
New Zealand
State/province [1] 4358 0
Taranaki

Funding & Sponsors
Funding source category [1] 285414 0
Self funded/Unfunded
Name [1] 285414 0
Country [1] 285414 0
Primary sponsor type
Hospital
Name
Taranaki Base Hospital
Address
23 David Street, Westown, New Plymouth 4310, Taranaki
Country
New Zealand
Secondary sponsor category [1] 284265 0
None
Name [1] 284265 0
Address [1] 284265 0
Country [1] 284265 0
Secondary sponsor category [2] 284274 0
Individual
Name [2] 284274 0
Dr Robert Primhak
Address [2] 284274 0
Taranaki Base Hospital, 23 David Street, Westown, New Plymouth 4310, Taranaki
Country [2] 284274 0
New Zealand
Other collaborator category [1] 276857 0
Individual
Name [1] 276857 0
Dr Yun Mi Kim
Address [1] 276857 0
Taranaki Base Hospital, 23 David Street, Westown, New Plymouth 4310, Taranaki
Country [1] 276857 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287427 0
Central Ethic Committee
Ethics committee address [1] 287427 0
Ethics committee country [1] 287427 0
New Zealand
Date submitted for ethics approval [1] 287427 0
16/06/2012
Approval date [1] 287427 0
Ethics approval number [1] 287427 0

Summary
Brief summary
Examination of the throat is a routine part of the examination of an unwell child, but is usually saved until last as it is often challenging and upsetting to a younger unco-operative child. The traditional method of examination, described in paediatric textbooks, is for the child to sit on the caregiver’s lap, facing the doctor, with the caregiver restraining with one hand around the body and arms and the other around the head, possibly with the child’s legs gripped between the caregiver’s knees. Over the years the principal investigator has developed an alternative technique for in young children which he believes to be easier and less upsetting. This technique requires the examiner to sit opposite the caregiver, and positions the child supine with the head on the examiner’s knees and the child’s trunk and bottom supported by the caregiver’s lap. The caregiver holds the child’s hands. The head is controlled by the examiner’s knees and the throat is examined upside down. All children under the age of three years referred to the Paediatric Assessment Unit in Taranaki Base Hospital in whom a throat examination is clinically indicated will be eligible for the study. Informed consent will be obtained from the caregiver. The child will be randomly allocated to one of the two methods using random number generated allocation in sealed envelopes, stratified by age range (0<12 months, 12<24 months and 24<36 months). The only exclusion criteria will be lack of consent, or a clinical contra-indication to examining the throat (e.g. croup).
The two methods will be explained to all staff participating and a laminated sheet describing each method will be available in the study box. The doctor examining the throat will use the allocated method. If it is not possible to complete an adequate throat examination by the allocated method then the other method may subsequently be used.
The caregiver will rate the examination on a Likert scale for
a) Upset to the child
b) Ease of restraining the child
The examiner will rate the method on a Likert scale for
a) Ease of examination
b) Adequacy of view
The time taken to complete a throat examination will also be recorded.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 34292 0
Address 34292 0
Country 34292 0
Phone 34292 0
Fax 34292 0
Email 34292 0
Contact person for public queries
Name 17539 0
Dr Rob Primhak
Address 17539 0
Taranaki Base Hospital, 23 David Street, Westown,New Plymouth 4310, Taranaki
Country 17539 0
New Zealand
Phone 17539 0
+64279185811
Fax 17539 0
+646753 7791
Email 17539 0
[email protected]
Contact person for scientific queries
Name 8467 0
Dr Robert Primhak
Address 8467 0
Taranaki Base Hospital, 23 David Street, New Plymouth 4310, Taranaki
Country 8467 0
New Zealand
Phone 8467 0
+64279185811
Fax 8467 0
+646753 7791
Email 8467 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.