ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

Condition category

Condition code

Respiratory

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]

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]

Tolerability of procedure (patient distress) rated by caregiver on a Likert scale.

Timepoint [1]

Immediate

Primary outcome [2]

Effectiveness of procedure (clarity of view) rated by doctor on a Likert scale

Timepoint [2]

Immediate

Secondary outcome [1]

Ease of examination (rated by doctor on Likerts scale)

Timepoint [1]

Immediate

Secondary outcome [2]

Time taken (measured by doctor)

Timepoint [2]

Immediate

Secondary outcome [3]

Ease of restraint (rated by caregiver on a Likert scale)

Timepoint [3]

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?

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]

New Zealand

State/province [1]

Taranaki

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Taranaki Base Hospital

Address

23 David Street, Westown, New Plymouth 4310, Taranaki

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Secondary sponsor category [2]

Individual

Name [2]

Dr Robert Primhak

Address [2]

Taranaki Base Hospital, 23 David Street, Westown, New Plymouth 4310, Taranaki

Country [2]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Dr Yun Mi Kim

Address [1]

Taranaki Base Hospital, 23 David Street, Westown, New Plymouth 4310, Taranaki

Country [1]

New Zealand

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Central Ethic Committee

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

16/06/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Rob Primhak

Address

Taranaki Base Hospital, 23 David Street, Westown,New Plymouth 4310, Taranaki

Country

New Zealand

Phone

+64279185811

Fax

+646753 7791

robert.primhak@tdhb.org.nz

Contact person for scientific queries

Name

Dr Robert Primhak

Address

Taranaki Base Hospital, 23 David Street, New Plymouth 4310, Taranaki

Country

New Zealand

Phone

+64279185811

Fax

+646753 7791

robert.primhak@tdhb.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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically