Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12610000236099
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
22/03/2010
Date last updated
5/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of postoperative nausea, vomiting and pain after adenotonsillectomy or tonsillectomy
Scientific title
Study of postoperative nausea, vomiting and pain after adenotonsillectomy or tonsillectomy
Secondary ID [1] 1522 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative nausea and vomiting and pain long term follow-up after adeno-tonsillectomy or tonsillectomy. 256961 0
Condition category
Condition code
Anaesthesiology 257104 257104 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Elective surgical Adeno-tonsillectomy or tonsillectomy.
Participants recruited over 12 months.
Approx. duration of surgical procedure 10-45 min.
Intervention code [1] 256138 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257999 0
Incidence of postoperative nausea and vomiting following adeno-tonsillectomy over the first postoperative week By clinical assessment and follow-up phone calls
Timepoint [1] 257999 0
one week (day of surgery, day 3 and day 7 post surgery)
Secondary outcome [1] 263553 0
Incidence of pain following adeno/tonsillectomy and patient/parent satisfaction By clinical assessment and follow-up phone calls
Timepoint [1] 263553 0
one week (day of surgery, day 3 and day 7 post surgery)

Eligibility
Key inclusion criteria
Patients with elective adeno-tonsillectomy or tonsillectomy.
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
29/01/2010
Date of last participant enrolment
Anticipated
Actual
20/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 256641 0
Hospital
Name [1] 256641 0
Princess Margaret Hospital for Children
Country [1] 256641 0
Australia
Funding source category [2] 288380 0
Charities/Societies/Foundations
Name [2] 288380 0
Princess Margaret Hospital Foundation
Country [2] 288380 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern
Address
Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 255928 0
Individual
Name [1] 255928 0
Ric Bergesio
Address [1] 255928 0
Princess Margaret Hospital for Children Department of Anaesthesia Roberts Road Subiaco, WA 6008
Country [1] 255928 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290264 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 290264 0
Ethics committee country [1] 290264 0
Australia
Date submitted for ethics approval [1] 290264 0
Approval date [1] 290264 0
15/10/2009
Ethics approval number [1] 290264 0
1723/EP

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

Contacts
Principal investigator
Name 30927 0
Prof Britta Regli-von Ungern-Sternberg
Address 30927 0
Department of Anaesthesia and Pain Management Princess Margaret Hospital for Children Roberts Road Subiaco WA 6008
Country 30927 0
Australia
Phone 30927 0
+61893408109
Fax 30927 0
Email 30927 0
[email protected]
Contact person for public queries
Name 14174 0
Britta Regli-von Ungern
Address 14174 0
Princess Margaret Hospital for Children Department of Anaesthesia Roberts Road Subiaco, WA 6008
Country 14174 0
Australia
Phone 14174 0
+61893408109
Fax 14174 0
Email 14174 0
[email protected]
Contact person for scientific queries
Name 5102 0
Britta Regli-von Ungern
Address 5102 0
Princess Margaret Hospital for Children Department of Anaesthesia Roberts Road Subiaco, WA 6008
Country 5102 0
Australia
Phone 5102 0
+61893408109
Fax 5102 0
Email 5102 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.