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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 256641 0
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008
Country [1] 256641 0
Australia
Funding source category [2] 288380 0
Charities/Societies/Foundations
Name [2] 288380 0
Princess Margaret Hospital Foundation
Address [2] 288380 0
68 Hay street
Subiaco
WA 6008
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
Princess Margaret Hospital
Roberts Road
Subiaco
WA 6008
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
The aim of this study is to identify the types of complications, concerns and outcomes experienced by children who have had either adenotonsillectomy or tonsillectomy, at the three and seven day point following the procedure. Based on analysis of this data the recommended care and support for this group of patients after discharge may be modified to improve patient outcomes.
Trial website
Trial related presentations / publications
Paediatr Anaesth. 2013 Aug;23(8):690-6. doi: 10.1111/pan.12170. Epub 2013 May 13.

Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up.

Stanko D, Bergesio R, Davies K, Hegarty M, von Ungern-Sternberg BS.

Source: Department of Anaesthesia and Pain Management, Princess Margaret Hospital for Children, Perth, WA, Australia.

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
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 14174 0
Prof 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
britta.regli-vonungern@health.wa.gov.au
Contact person for scientific queries
Name 5102 0
Prof 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
britta.regli-vonungern@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary