Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000054516
Ethics application status
Approved
Date submitted
7/01/2015
Date registered
22/01/2015
Date last updated
22/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving postoperative tonsillectomy pain management in children – a double blinded randomised control trial of a patient analgesia information sheet
Scientific title
Children undergoing tonsillectomy given post operative analgesia information sheet with the primary outcome assessed being parents knowledge and assessment of analgesia and children's self reported pain
Secondary ID [1] 285922 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative analgesia 293844 0
Paediatric tonsillectomy 293845 0
Condition category
Condition code
Surgery 294148 294148 0 0
Other surgery
Anaesthesiology 294238 294238 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Allocation of an analgesia information sheet to half patient population. This information sheet included specific instructions of analgesia regime and information surrounding the analgesia. It was given to the parents immediately post-operative by the operating surgeon. The parents were advised not to open the envelope until home. Routine post operative peri operative care was not changed.
Intervention code [1] 290898 0
Other interventions
Comparator / control treatment
Control was randomly half patients not given information sheet
Control group
Active

Outcomes
Primary outcome [1] 293943 0
Knowledge of analgesia used. A questionnaire was formulated by the principal researcher. This included 9 questions; knowledge and understanding questions. The parents were asked to fill in the questionnaire at day 10 post operative.
Timepoint [1] 293943 0
Day 10 post operative questionnaire
Secondary outcome [1] 312207 0
Pain assessment
Timepoint [1] 312207 0
Pain scale used at day 3, 5, 7
Scale used was Wong-Baker FACES Pain Rating Scale. The child indicated which pain level they were.
Also used was the faces, legs, arms, cry and consolibility - FLACC scale. The parents assessed the pain of the child using the FLACC scale.

Eligibility
Key inclusion criteria
Children, undergoing tonsillectomy who were prescribed oxycodone for analgesia
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children were not involved in the study if there were contraindications to the analgesia prescribed

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2013
Actual
23/05/2013
Date of last participant enrolment
Anticipated
Actual
13/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290501 0
Self funded/Unfunded
Name [1] 290501 0
Lucas Bailey
Country [1] 290501 0
Australia
Primary sponsor type
Individual
Name
Lucas Bailey
Address
John Flynn Hospital
42 Inland Drive, Tugun QLD 4224
Country
Australia
Secondary sponsor category [1] 289200 0
None
Name [1] 289200 0
Address [1] 289200 0
Country [1] 289200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292160 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 292160 0
Ethics committee country [1] 292160 0
Australia
Date submitted for ethics approval [1] 292160 0
Approval date [1] 292160 0
01/05/2013
Ethics approval number [1] 292160 0
13/18.

Summary
Brief summary
Allocation of an analgesia information sheet following tonsillectomy in children. The primary purpose of the study was to find that if allocation of an information sheet improved post operative analgesia in children and to assess if parents were more knowledgeable regarding analgesia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53830 0
Dr Lucas Bailey
Address 53830 0
John Flynn Hospital
Address: 42 Inland Drive, Tugun QLD 4224
Country 53830 0
Australia
Phone 53830 0
+61421675999
Fax 53830 0
Email 53830 0
[email protected]
Contact person for public queries
Name 53831 0
Lucas Bailey
Address 53831 0
John Flynn Hospital
Address: 42 Inland Drive, Tugun QLD 4224
Country 53831 0
Australia
Phone 53831 0
+61421675999
Fax 53831 0
Email 53831 0
[email protected]
Contact person for scientific queries
Name 53832 0
Lucas Bailey
Address 53832 0
John Flynn Hospital
Address: 42 Inland Drive, Tugun QLD 4224
Country 53832 0
Australia
Phone 53832 0
+61421675999
Fax 53832 0
Email 53832 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
SourceTitleYear of PublicationDOI
EmbaseImproving postoperative tonsillectomy pain management in children - A double blinded randomised control trial of a patient analgesia information sheet.2015https://dx.doi.org/10.1016/j.ijporl.2015.03.003
N.B. These documents automatically identified may not have been verified by the study sponsor.