Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000044820
Ethics application status
Approved
Date submitted
16/12/2011
Date registered
10/01/2012
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Procedure specific pain profiles & parental pain information access for common surgical procedures
Scientific title
Procedure specific pain profiles & parental pain information access for common surgical procedures
Secondary ID [1] 279623 0
Governance, Evidence, Knowledge & Outcomes (GEKO)
Research Governance

Quality Activity number 3388
Universal Trial Number (UTN)
Trial acronym
PSPP: Procedure Specific Pain Profiles
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Identifying post procedure pain levels and changes over time 285417 0
Parental access to pain information. 285528 0
Time frame for patients to return to normal activities. 285529 0
Identify nausea and vomiting rates. 285530 0
Condition category
Condition code
Anaesthesiology 285599 285599 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This audit will examine the pain experienced by children following the most common procedures performed at Princess Margaret Hospital/Perth Children's Hospital under general anaesthesia. We have selected the 36 common groups of procedures and are recruiting 50 patients in each group. The surgical groups include Ear, Nose and Throat, Urology, Orthopaedic, Gastro-Intestinal, Dental and miscellaneous general surgery.
The audit involves a telephone follow up interview after informed verbal consent has been obtained. The audit questions include questions on issues regarding pain management, post operative nausea, vomiting and pain frequency and treatment and parental rating of overall treatment. The parents will be contacted a few days after surgery and then followed up until they return to normal activity.
Intervention code [1] 283992 0
Not applicable
Comparator / control treatment
Not applicable - No treatment
Investigative telephone interview
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286164 0
Benchmarking levels of pain control, treatment of postoperative nausea and vomiting, parental and child satisfaction of the targeted surgical groups - MUA (radius), dental, appendicectomy, nail bed repairs and facial lacerations. A telephone questionnaire will be used for the assessment
Timepoint [1] 286164 0
Day of surgery
Primary outcome [2] 286165 0
Benchmarking child's return to normal behaviour via telephone questionnaires
Timepoint [2] 286165 0
Within 2-5 days following procedure until return to normal function.
Primary outcome [3] 286169 0
Levels of Pain control via telephone questionnaires
Timepoint [3] 286169 0
Within 2-5 days following procedure until return to normal function.
Secondary outcome [1] 295291 0
Benchmarking retention, source and provison of pain control options for parents via telephone questionnaire
Timepoint [1] 295291 0
Within 2-5 days following procedure until return to normal function.
Secondary outcome [2] 295297 0
Levels of PONV control via telephone questionnaire
Timepoint [2] 295297 0
Within 2-5 days following procedure until return to normal function.
Secondary outcome [3] 295442 0
Benchmarking retention, source and provison of nausea, vomiting treatment options for parents via telephone questionnaire
Timepoint [3] 295442 0
Within 2-5 days following procedure until return to normal function.

Eligibility
Key inclusion criteria
Patient has undergone MUA (without metal work); Dental extractions - front teeth only, molars +/- front teeth, baby teeth & accident; appendicectomy - laparoscopic or open, nail bed repairs and facial lacerations.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking family
Surgical procedures other than those listed in the inclusion criteria.
Parent or child decline to participate

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/11/2011
Actual
7/02/2012
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
1800
Accrual to date
1452
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12859 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 25335 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 284398 0
Hospital
Name [1] 284398 0
Perth Children's Hospital
Country [1] 284398 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
c/o Department of Anaesthesia & Pain Management, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA6009
Country
Australia
Secondary sponsor category [1] 283327 0
None
Name [1] 283327 0
Address [1] 283327 0
Country [1] 283327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286357 0
Princess Margaret Hospital Ethics and Research Governance Committee
Ethics committee address [1] 286357 0
Princess Margaret children's Hospital
Ethics Committee
GPO Box D184
Perth WA 6840
Ethics committee country [1] 286357 0
Australia
Date submitted for ethics approval [1] 286357 0
Approval date [1] 286357 0
29/11/2011
Ethics approval number [1] 286357 0
Quality activity 3388

Summary
Brief summary
Satifactory treatment and parental support for pain relief, and nausea and vomiting. This has not been benchmarked for children undergoing surgery for fractures of the lower arm detal trauma, nail bed injury, face cuts and appendicectomy within our hospital. We are undertaking a telephone survey of parents and children who have had the above procedures to improve our service and patient care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33546 0
Prof Britta von Ungern-Sternberg
Address 33546 0
Perth Children's Hospital Department of Anaesthesia and Pain Management
15 Hospital Avenue
Nedlands
WA 6009
Country 33546 0
Australia
Phone 33546 0
+61 8 93408109
Fax 33546 0
Email 33546 0
[email protected]
Contact person for public queries
Name 16793 0
Prof Britta von Ungern-Sternberg
Address 16793 0
Perth Children's Hospital Department of Anaesthesia and Pain Management
15 Hospital Avenue
Nedlands
WA 6009
Country 16793 0
Australia
Phone 16793 0
+61 893408109
Fax 16793 0
Email 16793 0
[email protected]
Contact person for scientific queries
Name 7721 0
Prof Britta von Ungern-Sternberg
Address 7721 0
Perth Children's Hospital Department of Anaesthesia and Pain Management
15 Hospital Avenue
Nedlands
WA 6009
Country 7721 0
Australia
Phone 7721 0
+61 893408109
Fax 7721 0
Email 7721 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Recruitment is still ongoing and at this stage the investigators will not be sharing data from this trial.


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.